A Phase 1/2 interventional study of Oral Cabotegravir (CAB) and Oral Rilpivirine (RPV) in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 19 sites in 5 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment
The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.
IMPAACT 2017 was a Phase I/II, multi-center, open-label, non-comparative dose-finding study with the primary objective of evaluating the safety, acceptability, tolerability, and PK of oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) as well as long-acting rilpivirine (RPV LA) in adolescents living with HIV-1, who are 12 to \<18 years of age, ≥35kg, and virologically suppressed.
The study design included two cohorts of participants and five study steps. In Cohort 1, Step 1 participants received either oral CAB or oral rilpivirine (RPV) for at least four weeks and up to six weeks (maximum). In Cohort 1, Step 2 participants received intramuscular injectable formulations of the study products, either CAB LA or RPV LA. Cohort 1 participants were assigned either CAB (Cohort 1C) or RPV (Cohort 1R) based on their pre-study combination Antiretroviral Therapy (cART) regimen. Participants on a PI-based and/or NNRTI-based cART regimen were assigned to Cohort 1C, and participants on a non-boosted INSTI-based cART regimen were assigned to Cohort 1R. All participants continued their pre-study cART regimen during Cohort 1.
During Cohort 2, all participants discontinued their pre-study cART regimen and received both study products, CAB and RPV, at the doses established in Cohort 1. Cohort 2 participants enrolled to either Cohort 2A to receive both oral CAB + oral RPV (Step 3) followed by both CAB LA + RPV LA (Step 4) or Cohort 2B to directly receive both CAB LA + RPV LA without an oral lead-in phase (Step 5). If eligible, Cohort 1 participants were able to enroll into Cohort 2 (i.e., Cohort 1 Rollover). However, Cohort 2 participants who were not previously enrolled in Cohort 1 (i.e., Cohort 1-Naïve) were the primary group for analyses and conclusions. No participants enrolled into Cohort 2B, direct to injection (Step 5). Therefore, all references to Cohort 2 refer to Cohort 2A (Steps 3 and 4).
Two interim analyses were planned. The first interim analysis established the doses for Cohort 2 and determined whether to open Cohort 2 to Cohort 1 participants who met criteria to enter Cohort 2. The second interim analysis provided justification to open Cohort 2 to additional participants who were not previously enrolled in Cohort 1. A final analysis of Cohort 1 data was performed to confirm the final doses for Cohort 2.
Safety and PK evaluations were performed during Steps 1-5 and long-term safety follow-up (LSFU). Antiviral activity assessments were performed during Steps 1-5. Acceptability and tolerability were assessed during Steps 1-5 and LSFU, with all participants completing quantitative questionnaires and a subset of participants completing in-depth qualitative interviews. Additionally, parents/caregivers of a subset of U.S. participants from U.S. sites were also enrolled to complete a single in-depth qualitative interview. Because objectives related to parents/caregivers were exploratory, these outcomes are not described here.
Cohort 1 participants were followed for up to 64 weeks. Participants were followed for at least four weeks in Step 1 (oral phase) and at least 12 weeks in Step 2 (injection phase). All Step 2 participants were followed (on cART, off study product) for up to an additional 48 weeks as part of LSFU after their last study product injection. If eligible, Cohort 1 participants enrolled into Cohort 2 before completing LSFU. For Cohort 1, Step 1 participants not progressing to Step 2, the last visit was targeted to be completed 28 days after the participant's last oral study product use.
Cohort 2 participants were followed for up to 188 (Cohort 2B) or 192 (Cohort 2A) weeks. Participants were followed for at least four weeks in Step 3 (oral phase) and 92 weeks in Step 4/Step 5 (injection phase). After completing 92 weeks of follow-up in Step 4/Step 5 (injection phase), Cohort 2 participants who continued access to injectable study products through a mechanism external to the protocol exited the study. If it was not possible for participants to access injections of CAB LA + RPV LA from non-study sources at the completion of their Step 4 Week 96 or Step 5 Week 92 visit, participants remained in the study safety extension for up to 48 weeks. Participants who permanently discontinued injectable study product use during Cohort 2, Step 4/Step 5, or did not wish to continue to access the study products through the external mechanism after their Week 96 visit, were followed (on cART, off study product) for an additional 48 weeks as part of LSFU after their last study product injection, except for participants in the study safety extension. Participants in the study safety extension who decided to permanently discontinue injectable study product or who had not established access to study product after the 48 weeks in the study safety extension would exit the study (not enter LSFU). For Cohort 2, Step 3 participants not progressing to the injection phase, the last visit was targeted to be completed 28 days after the participant's last oral study product use. Female participants who discontinued study product use (either oral or injectable study product) due to pregnancy during Steps 1-5 were followed for an additional 48 weeks in LSFU to assess long-term safety and washout PK of the study products, except for participants in the study safety extension. Participants who became pregnant during the safety extension were only followed until the pregnancy outcome was determined.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 168 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Cohort 1 Step 1, Cohort 2 Step 3, and Cohort 2 Step 5
All the following criteria must be met for inclusion of any adolescent participant in Step 1 of Cohort 1, or in Step 3 of Cohort 2, unless otherwise noted:
At enrollment, body weight greater than or equal to 35 kg (77 lbs)
For at least 3 consecutive months (defined as 90 consecutive days) prior to screening, and prior to enrollment, has been on stable unchanged cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.
Has at least one documented plasma HIV-1 RNA less than the lower limit of detection of the assay from a specimen collected less than 6 months (defined as within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 12-18 months (defined as 365 to 545 days) prior to entry.
OR
For Cohort 1 participants enrolling to Cohort 2, has documented plasma HIV-1 RNA results less than the lower limit of detection of the assay from all indicated Cohort 1 study visits with their Cohort 1 Week 16 visit completed within 28 days prior to Cohort 2 entry.
At screening, has Grade 2 or lower of all the following laboratory test results:
For females of , at entry, currently using at least one allowable effective method of , and agrees to use at least one allowable effective method of contraception throughout study participation, for at least 30 days after discontinuation of oral study product, and for at least 48 weeks after discontinuation of CAB LA and/or RPV LA, and intending to delay any planned pregnancies until 30 days after last oral study product use or until 48 weeks after last injectable study product use.
Exclusion Criteria: Cohort 1 Step 1, Cohort 2 Step 3, or Cohort 2 Step 5
Adolescents will be excluded from the study if any of the following are identified during the screening period:
Within 6 months (defined as within 179 days) prior to entry, two consecutive documented HIV-1 RNA values greater than the lower limit of detection of the assay
Inclusion/Exclusion Criteria, Step 2 (Cohort 1 Progression Criteria, Step 1 to Step 2)
Cohort 1 Step 1 participants will be assessed for eligibility to progress from the oral lead-in phase (Step 1) to the injection phase (Step 2) primarily based on the safety assessments from the Cohort 1 Step 1 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product. See the study protocol for Week 4a and Week 4b visit scheduling, order of procedures, and visit windows, respectively.
All of the following criteria must be met in order for participants to be included in Cohort 1 Step 2:
At Cohort 1 Step 1 Week 4a study visit, or from confirmatory repeat testing of Cohort 1 Step 1 Week 4a study visit laboratory tests, has Grade 2 or lower of all the following laboratory test results:
Participants who meet any of the following criteria will be excluded from Cohort 1 Step 2:
Inclusion/Exclusion Criteria, Step 4 (Cohort 2 Progression Criteria, Step 3 to Step 4)
Cohort 2 Step 3 participants will be assessed for eligibility to progress from the oral lead-in phase (Step 3) to the injection phase (Step 4) primarily based on the safety assessments from the Cohort 2 Step 3 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product. See the study protocol for Week 4a and Week 4b visit scheduling, order of procedures, and target visit windows, respectively.
All of the following criteria must be met in order for participants to be included in Cohort 2 Step 4:
At Cohort 2 Step 3 Week 4a study visit, or from confirmatory repeat testing of Cohort 2 Step 3 Week 4a study visit laboratory tests, has Grade 2 or lower of the following laboratory test results:
Participants who meet any of the following criteria will be excluded from Cohort 2 Step 4:
Inclusion/Exclusion Criteria: Parents/Caregivers
Selected parents or caregivers of adolescents may be enrolled to complete qualitative phone interviews. See the study protocol for more information regarding the selection process, and coordination of scheduling the interviews. All of the following criteria must be met for the parent/caregiver to be enrolled:
Parents and/or caregivers of participants who meet the following criterion will be excluded from study participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): CAB LA administered as three single intramuscular (IM) injections four weeks apart (600 mg injection at Week 4b, 400 mg injection at Week 8, and 400 mg injection at Week 12). Step 2 (Q8W dosing): CAB LA administered as two single IM injections four weeks apart (600 mg injection at Week 4b and 600 mg injection at Week 8).
Drug: Oral Cabotegravir (CAB) · Drug: Long-Acting Injectable Cabotegravir (CAB LA) · Drug: Combination Antiretroviral Therapy (cART)
Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks. Step 2 (Q4W dosing): RPV LA administered as three single IM injections four weeks apart (900 mg injection at Week 4b, 600 mg injection at Week 8, 600 mg injection at and Week 12). Step 2 (Q8W dosing): RPV LA administered as two single IM injections four weeks apart (900 mg injection at Week 4b and 900 mg injection at Week 8).
Drug: Oral Rilpivirine (RPV) · Drug: Long-Acting Injectable Rilpivirine (RPV LA) · Drug: Combination Antiretroviral Therapy (cART)
Step 3: CAB administered orally as one 30 mg tablet once daily and RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks. Step 4: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Week 4b and at Week 8. Subsequent injections: starting at Week 16, CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection every eight weeks through Week 96 or final safety extension visit.
Drug: Oral Cabotegravir (CAB) · Drug: Oral Rilpivirine (RPV) · Drug: Long-Acting Injectable Cabotegravir (CAB LA) · Drug: Long-Acting Injectable Rilpivirine (RPV LA)
Step 5: First and second injections: CAB LA administered as a 600 mg IM injection and RPV LA administered as a 900 mg IM injection at Entry and at Week 4. Subsequent injections: starting at Week 12, CAB LA administered as a 600 mg IM injection and RPV LA administered as 900 mg IM injection every eight weeks through Week 92 or final safety extension visit.
Drug: Long-Acting Injectable Cabotegravir (CAB LA) · Drug: Long-Acting Injectable Rilpivirine (RPV LA)
30 mg tablets administered orally
25 mg tablets administered orally
Also known as: Edurant
Administered by intramuscular (IM) injection
Administered by intramuscular (IM) injection
Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)
We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose
Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)
We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose
Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)
We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C)
We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample.
Time frame: Week 16
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, 6, and 8
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, 6, 8
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Time frame: Week 4b, Week 8, Week 12
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample.
Time frame: Week 16
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, and 8
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, and 8
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Time frame: Week 4b, Week 8
Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1)
We present the proportion of participants with results of HIV-1 RNA \< 50 copies/mL at Week 16
Time frame: Week 16
Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1)
Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst".
Time frame: Week 8
Median Dimension of Quality of Life Scores
A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions.
Time frame: Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 24
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 24
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 48
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 48
Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)
We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample.
Time frame: Week 2
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 8 and Week 24
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 16 and Week 24
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 8 and Week 48
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 16 and Week 48
Accrual for Cohort 1 occurred between April 2019 and November 2021 at 15 different medical clinic sites across Botswana, South Africa, Thailand, and the United States. Accrual for Cohort 2 occurred between July 2021 and August 2022 at 18 different medical clinic sites across Botswana, South Africa, Thailand, Uganda, and the United States.
| Milestone | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA |
|---|---|---|---|---|
| Started | 30 | 25 | 0 | 0 |
| Completed | 29 | 23 | 0 | 0 |
| Not completed | 1 | 2 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 |
| Milestone | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA |
|---|---|---|---|---|
| Started | 29 | 23 | 0 | 0 |
| Completed | 28 | 21 | 0 | 0 |
| Not completed | 1 | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Milestone | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA |
|---|---|---|---|---|
| Started | 0 | 0 | 144 | 0 |
| Completed | 0 | 0 | 141 | 0 |
| Not completed | 0 | 0 | 3 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 |
| Withdrew: Non-compliance with study treatment | 0 | 0 | 1 | 0 |
| Milestone | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA |
|---|---|---|---|---|
| Started | 0 | 0 | 141 | 0 |
| Completed | 0 | 0 | 140 | 0 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Milestone | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA |
|---|---|---|---|---|
| Started | 0 | 0 | 140 | 0 |
| Completed | 0 | 0 | 137 | 0 |
| Not completed | 0 | 0 | 3 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 2 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Milestone | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA |
|---|---|---|---|---|
| Started | 0 | 0 | 117 | 0 |
| Completed | 0 | 0 | 116 | 0 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB |
|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1) | 0 (0 to 0.12) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB |
|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) |
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB |
|---|---|
| Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) |
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB |
|---|---|
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) |
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB |
|---|---|
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1) | 0.24 (0.10 to 0.44) | 0.22 (0.07 to 0.44) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1) | 0.035 (0.001 to 0.18) | 0.04 (0.001 to 0.22) |
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) | 0 (0 to 0.15) |
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) | 0.044 (0.001 to 0.22) |
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1) | 0 (0 to 0.12) | 0 (0 to 0.15) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2) | 0.10 (0.05 to 0.18) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation.
| (h*ug)/mL | Cohort 1C: CAB |
|---|---|
| Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C) | 139 ± 59.1 |
We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples.
| mL/h | Cohort 1C: CAB |
|---|---|
| Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C) | 216.0 ± 59.1 |
We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples
| ug/mL | Cohort 1C: CAB |
|---|---|
| Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C) | 8.90 ± 43.1 |
We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples.
| h | Cohort 1C: CAB |
|---|---|
| Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C) | 2.73 ± 1.13 |
We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples.
| ug/mL | Cohort 1C: CAB |
|---|---|
| Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C) | 4.09 ± 96.1 |
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample.
| ug/mL | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W) | 2.91 ± 58.8 | 0.0644 ± 59.9 |
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
| ug/mL | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W) | 9.56 ± 32.2 | 0.132 ± 35.5 |
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
| h | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W) | 1.50 ± 0.551 | 89.6 ± 162 |
We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
| ug/mL | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Week 4b | 5.46 ± 39.6 | 0.0704 ± 227 |
| Week 8 | 2.10 ± 37.0 | 0.0441 ± 75.9 |
| Week 12 | 2.73 ± 76.7 | 0.0555 ± 56.7 |
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample.
| ug/mL | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W) | 1.01 ± 237 | 0.0449 ± 38.2 |
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
| ug/mL | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W) | 6.42 ± 42.2 | 0.129 ± 39.4 |
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
| h | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W) | 1.84 ± 0.829 | 18.6 ± 53.5 |
We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
| ug/mL | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Week 4b | 2.89 ± 194 | 0.0703 ± 24.8 |
| Week 8 | 1.33 ± 105 | 0.0327 ± 28.8 |
We present the proportion of participants with results of HIV-1 RNA \< 50 copies/mL at Week 16
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1) | 0.964 | 1.00 |
Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst".
| proportion of participants | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1) | 0 | 0.043 |
A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions.
| score on a scale | Cohort 1C: CAB | Cohort 1R: RPV |
|---|---|---|
| Physical Functioning | 96.9 (90.6 to 100) | 100 (93.8 to 100) |
| Emotional Functioning | 95 (80 to 100) | 95 (90 to 100) |
| Social Functioning | 100 (95 to 100) | 100 (95 to 100) |
| School Functioning | 80 (65 to 90) | 85 (80 to 95) |
| Psychosocial Functioning | 91.7 (76.7 to 96.7) | 91.7 (86.7 to 96.7) |
| Total Functioning | 93.5 (82.6 to 96.7) | 94.6 (90.2 to 97.8) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2) | 0.14 (0.08 to 0.23) |
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2) | 0.02 (0.003 to 0.07) |
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2) | 0 (0 to 0.04) |
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2) | 0.02 (0.002 to 0.07) |
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2) | 0 (0 to 0.037) |
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2) | 0 (0 to 0.04) |
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
| proportion of participants | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2) | 0 (0 to 0.04) |
We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample.
| ug/mL | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| CAB concentration | 6.65 ± 42.3 |
| RPV concentration | 0.0708 ± 59.0 |
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
| ratio | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| CAB Ratio | 1.14 ± 107 |
| RPV Ratio | 1.35 ± 47.1 |
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
| ratio | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| CAB Ratio | 0.974 ± 47.0 |
| RPV Ratio | 1.22 ± 32.7 |
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
| ratio | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| CAB Ratio | 1.31 ± 97.6 |
| RPV Ratio | 1.84 ± 47.1 |
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
| ratio | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|
| CAB Ratio | 1.12 ± 50.9 |
| RPV Ratio | 1.68 ± 37.9 |
Collected over Cohort 1: study entry through final study visit (Week 16, premature discontinuation prior to Week 16, final long-term safety follow-up visit, or Cohort 2 entry) Cohort 2: study entry through final study visit (Week 96, premature discontinuation prior to Week 96, final long-term safety follow-up visit, or final safety extension visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1C: CAB | 0/30 (0%) | 1/30 (3.3%) | 28/30 (93.3%) |
| Cohort 1R: RPV | 0/25 (0%) | 0/25 (0%) | 23/25 (92%) |
| Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | 0/144 (0%) | 9/144 (6.3%) | 136/144 (94.4%) |
| Event | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|---|---|
| Gastritis alcoholic haemorrhagicGastrointestinal disorders | 1/30 | 0/25 | 1/144 |
| MalariaInfections and infestations | 0/30 | 0/25 | 2/144 |
| CataractEye disorders | 0/30 | 0/25 | 1/144 |
| Anaphylactic reactionImmune system disorders | 0/30 | 0/25 | 1/144 |
| Dengue feverInfections and infestations | 0/30 | 0/25 | 1/144 |
| Respiratory tract infectionInfections and infestations | 0/30 | 0/25 | 1/144 |
| Typhoid feverInfections and infestations | 0/30 | 0/25 | 1/144 |
| Radius fractureInjury, poisoning and procedural complications | 0/30 | 0/25 | 1/144 |
| Aspartate aminotransferase increasedInvestigations | 0/30 | 0/25 | 1/144 |
| Blood creatine phosphokinase increasedInvestigations | 0/30 | 0/25 | 1/144 |
| Event | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA |
|---|---|---|---|
| Injection site painGeneral disorders | 9/30 | 9/25 | 57/144 |
| CoughRespiratory, thoracic and mediastinal disorders | 9/30 | 6/25 | 52/144 |
| HeadacheNervous system disorders | 3/30 | 8/25 | 42/144 |
| Upper respiratory tract infectionInfections and infestations | 4/30 | 2/25 | 30/144 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 6/30 | 5/25 | 29/144 |
| NauseaGastrointestinal disorders | 1/30 | 5/25 | 11/144 |
| Blood pressure increasedInvestigations | 6/30 | 0/25 | 23/144 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 4/30 | 5/25 | 28/144 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 2/30 | 5/25 | 26/144 |
| HypertensionVascular disorders | 6/30 | 0/25 | 6/144 |
Participants who have taken at least 1 dose of any study product on the respective cohort. For participants enrolled in both Cohort 1 and Cohort 2, the baseline value summarized is from the corresponding cohort. Baseline characteristics for parents/caregivers are not reported.
| Age, Continuous(years) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 | 15 (12 to 17) | 16 (12 to 17) | — | — | 15 (12 to 17) |
| Cohort 2 | — | — | 15 (12 to 17) | — | 15 (12 to 17) |
| Age, Customized(Participants) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 — 12 | 1 | 3 | — | 0 | 4 |
| Cohort 1 — 13 | 5 | 0 | — | 0 | 5 |
| Cohort 1 — 14 | 7 | 3 | — | 0 | 10 |
| Cohort 1 — 15 | 6 | 4 | — | 0 | 10 |
| Cohort 1 — 16 | 4 | 4 | — | 0 | 8 |
| Cohort 1 — 17 | 7 | 11 | — | 0 | 18 |
| Cohort 2 — 12 | — | — | 11 | — | 11 |
| Cohort 2 — 13 | — | — | 23 | — | 23 |
| Cohort 2 — 14 | — | — | 19 | — | 19 |
| Cohort 2 — 15 | — | — | 35 | — | 35 |
| Cohort 2 — 16 | — | — | 27 | — | 27 |
| Cohort 2 — 17 | — | — | 29 | — | 29 |
| Sex: Female, Male(Participants) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 — Female | 14 | 12 | — | — | 26 |
| Cohort 1 — Male | 16 | 13 | — | — | 29 |
| Cohort 2 — Female | — | — | 74 | — | 74 |
| Cohort 2 — Male | — | — | 70 | — | 70 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 — Hispanic or Latino | 0 | 3 | — | — | 3 |
| Cohort 1 — Not Hispanic or Latino | 30 | 22 | — | — | 52 |
| Cohort 1 — Unknown or Not Reported | 0 | 0 | — | — | 0 |
| Cohort 2 — Hispanic or Latino | — | — | 3 | — | 3 |
| Cohort 2 — Not Hispanic or Latino | — | — | 141 | — | 141 |
| Cohort 2 — Unknown or Not Reported | — | — | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 — American Indian or Alaska Native | 0 | 0 | — | — | 0 |
| Cohort 1 — Asian | 9 | 0 | — | — | 9 |
| Cohort 1 — Native Hawaiian or Other Pacific Islander | 0 | 0 | — | — | 0 |
| Cohort 1 — Black or African American | 21 | 21 | — | — | 42 |
| Cohort 1 — White | 0 | 4 | — | — | 4 |
| Cohort 1 — More than one race | 0 | 0 | — | — | 0 |
| Cohort 1 — Unknown or Not Reported | 0 | 0 | — | — | 0 |
| Cohort 2 — American Indian or Alaska Native | — | — | 0 | — | 0 |
| Cohort 2 — Asian | — | — | 36 | — | 36 |
| Cohort 2 — Native Hawaiian or Other Pacific Islander | — | — | 0 | — | 0 |
| Cohort 2 — Black or African American | — | — | 106 | — | 106 |
| Cohort 2 — White | — | — | 2 | — | 2 |
| Cohort 2 — More than one race | — | — | 0 | — | 0 |
| Cohort 2 — Unknown or Not Reported | — | — | 0 | — | 0 |
| Region of Enrollment, Customized(Participants) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 — United States | 8 | 17 | — | — | 25 |
| Cohort 1 — Botswana | 0 | 5 | — | — | 5 |
| Cohort 1 — South Africa | 14 | 3 | — | — | 17 |
| Cohort 1 — Uganda | 0 | 0 | — | — | 0 |
| Cohort 1 — Thailand | 8 | 0 | — | — | 8 |
| Cohort 2 — United States | — | — | 20 | — | 20 |
| Cohort 2 — Botswana | — | — | 25 | — | 25 |
| Cohort 2 — South Africa | — | — | 43 | — | 43 |
| Cohort 2 — Uganda | — | — | 20 | — | 20 |
| Cohort 2 — Thailand | — | — | 36 | — | 36 |
| HIV-1 RNA(Participants) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 — <50 copies/mL | 30 | 24 | — | — | 54 |
| Cohort 1 — >=50 copies/mL | 0 | 1 | — | — | 1 |
| Cohort 2 — <50 copies/mL | — | — | 138 | — | 138 |
| Cohort 2 — >=50 copies/mL | — | — | 6 | — | 6 |
| Quality of Life Dimension Scores(units on a scale) | Cohort 1C: CAB | Cohort 1R: RPV | Cohort 2A: Oral CAB + Oral RPV and CAB LA + RPV LA | Cohort 2B: CAB LA + RPV LA | Total |
|---|---|---|---|---|---|
| Cohort 1 Physical Functioning Dimension | 96.9 (93.8 to 100) | 100 (96.9 to 100) | — | — | 100 (93.8 to 100) |
| Cohort 1 Emotional Functioning Dimension | 90 (80 to 100) | 90 (70 to 100) | — | — | 90 (75 to 100) |
| Cohort 1 Social Functioning Dimension | 100 (90 to 100) | 95 (90 to 100) | — | — | 100 (90 to 100) |
| Cohort 1 School Functioning Dimension | 80 (70 to 90) | 70 (60 to 87.5) | — | — | 80 (65 to 90) |
| Cohort 1 Psychosocial Functioning Dimension | 90 (81.7 to 96.7) | 83.3 (76.7 to 95) | — | — | 90 (78.3 to 95) |
| Cohort 1 Total Functioning Dimension | 92.9 (87 to 96.7) | 89.1 (83.7 to 95.7) | — | — | 91.3 (83.7 to 95.8) |
| Cohort 2 Physical Functioning | — | — | 100 (93.8 to 100) | — | 100 (93.8 to 100) |
| Cohort 2 Emotional Functioning Dimension | — | — | 100 (85 to 100) | — | 100 (85 to 100) |
| Cohort 2 Social Functioning Dimension | — | — | 100 (90 to 100) | — | 100 (90 to 100) |
| Cohort 2 School Functioning Dimension | — | — | 80 (70 to 90) | — | 80 (70 to 90) |
| Cohort 2 Psychosocial Functioning | — | — | 91.7 (83.3 to 96.7) | — | 91.7 (83.3 to 96.7) |
| Cohort 2 Total Functioning | — | — | 94.6 (84.8 to 97.8) | — | 94.6 (84.8 to 97.8) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network. By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Ran from Apr 2019 to primary completion in Feb 2023, 46 months.
Results were first posted in May 2024, 1 year 2 months after primary completion.
Of 35 non-industry phase 1/2 interventional studies under HIV Infections, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's 46 months is below that.
Counting every sponsor, half of 42 studies reached it within 47 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cabotegravir · Rilpivirine
National Institute of Allergy and Infectious Diseases (NIAID) →