A Phase 1 interventional study of Oral CAB and CAB LA in HIV Infections, sponsored by ViiV Healthcare. Completed at 3 sites in China. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-13.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 1, Interventional, and Treatment
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Among 265 studies in HIV Infections by GlaxoSmithKline — 14 open to participants now, 26 under way, 8 of them phase 3. HIV Infections · GlaxoSmithKline.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 131st largest by enrollment of the 209 interventional ones that give a count, is one of 8 that started in 2018, is one of 82 in phase 1, and was the 187th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →14 of the 265 studies in HIV Infections by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in Romania, South Africa, Uganda
ViiV Healthcare · Sites in Netherlands
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years to 65 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 53 · Phase 3 68 · Phase 4 18
First in 1994; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 84 across the 209 interventional studies, 328 across the 14 observational. Of the 230 that completed or were terminated, 95 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
5 of the studies in HIV Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07053384ViiV HealthcareA Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | 2027-01-22 |
| NCT07934719ViiV HealthcareMass Balance and Absolute Bioavailability of [14C]-VH4011499 | 2027-02-18 |
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
| NCT07525544ViiV HealthcareA Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | 2027-05-05 |
| NCT07202546ViiV HealthcareA Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2027-10-28 |
Add all 5 to your calendar (.ics) → With an account.
Among the 265 studies in HIV Infections by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and prevention of HIV infection. CAB possesses attributes that allow formulation and delivery as a LA parenteral product. CAB is being developed as both oral and long acting (LA) injectable formulations. This study is designed to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during injection phase of the study. Approximately 60 subjects will be screened, of which, approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection phase of the study. The maximum study duration will be approximately 89 weeks including oral phase, injection phase and follow-up phase.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
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.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
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.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive oral doses of CAB 30 milligrams (mg) tablets once daily for 4 weeks followed by IM injectable suspension of CAB LA 600 mg at Week 5, Week 9, Week 17, Week 25 and Week 33. There will be an approximately 1-week washout period between the last oral dose and the first injection of CAB at Week 5.
Drug: Oral CAB · Drug: CAB LA
CAB tablet will be formulated as white to almost white, oval shaped, film coated 30 mg tablets, administered orally once daily. The CAB tablets will be packaged in bottles containing 30 tablets each.
CAB LA is a sterile white to slightly colored suspension containing 200 mg/mL of CAB as free acid for administration by IM injection in gluteus medius.
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or other situations as per investigator's judgement.
Time frame: Week 5 to 41
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hematology parameters were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: Activated partial thromboplastin time (APTT) prolonged, hemoglobin (Hb) (increased), white blood cells (WBC) (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Time frame: Week 5 to 41
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), bilirubin, calcium (hypercalcemia and hypocalcemia), carbon dioxide (CO2) (decreased), cholesterol (high), Creatine phosphokinase (CPK) increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Time frame: Week 5 to 41
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Time frame: Week 5 to 41
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: systolic blood pressure (SBP) (Low: \<85 millimeters of mercury \[mmHg\], High: \>160 mmHg), diastolic blood pressure (DBP) (Low: \<45 mmHg, High: \>100 mmHg), pulse rate (Low: \<40 mmHg, High: \>100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Week 5 to 41
Number of Participants Withdrawn Due to AEs- Injection Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Time frame: Week 5 to 41
Number of Participants Experiencing Injection Site Reactions (ISR)-Injection Phase
Injection site reactions were recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) is presented.
Time frame: Week 5 to 41
Concentration of Cabotegravir in Plasma at the End of the Dosing Interval (Ctau)-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Ctau following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Dosing of Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Maximum Observed Concentration (Cmax) Following Oral Dosing With Cabogegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Cmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Time of Occurrence of Cmax (Tmax) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Tmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Apparent Clearance Following Oral Dosing (CL/F) Following Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of CL/F following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Terminal Absorption Elimination Half-life (t1/2) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of t1/2 following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Apparent Terminal Phase Rate Constant (Lambda z) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Lambda z following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Volume of Distribution at Steady State (Vss) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Vss following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Ctau Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
AUC(0-tau) Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Cmax Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Tmax Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Ctau Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
AUC(0-tau) Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Cmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Tmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 7 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
CL/F Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of CL/F following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 7, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
T1/2 Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of t1/2 following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Lambda z Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Lambda z following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Vss Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Vss following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Number of Participants With Non-serious AEs and SAEs (Oral lead-in Phase)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity, Is a congenital anomaly/birth defect, other situation as per investigator's judgement.
Time frame: Up to Week 4
Number of Participants Withdrawn Due to AEs-oral lead-in Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Time frame: Up to Week 4
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included ALT, albumin, ALP, AST, bilirubin, calcium (hypercalcemia and hypocalcemia), CO2 decreased, cholesterol, CPK increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Time frame: Up to Week 4
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hematology parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: APTT prolonged, Hb (increased), WBC (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Time frame: Up to Week 4
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Time frame: Up to Week 4
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: SBP (Low \<85 mmHg, High: \>160 mmHg), DBP (Low: \<45 mmHg, High: \>100 mmHg), pulse rate (Low: \<40 mmHg, High: \>100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Time frame: Up to Week 4
Percentage of Participants With Injection Discontinuation-Injection Phase
Percentage of participants with injection discontinuation is presented.
Time frame: Week 5 to 41
Number of Participants With Grade 2 to 4 Injection Site Pain-Injection Phase
Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity is categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated. Higher grade indicates more severe condition. Number of participants who had at least one Grade 2 to 4 Injection site reaction is presented.
Time frame: Week 5 to 41
HIV-Prevention Treatment Satisfaction Total Score-Injection Phase
HIV-Prevention Treatment Satisfaction Questionnaire (change) (HIV-PrevTSQc) was used to assess participant tolerability and satisfaction to the treatment. It consisted total 13 questions. The experience of HIV prevention treatment was assessed using a scale from 3 (much more satisfied/effective/convenient/ flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now) to -3 (much less satisfied/effective/convenient/flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now). Total score was calculated by taking sum of scores of all questions. It ranges from -39 to 39, with higher scores indicating more satisfaction.
Time frame: At Week 10
Number of Participants With Acceptability of Cabotegravir for HIV Prevention
Number of participants who consider using cabotegravir for HIV prevention in the future is presented. Participants were asked if they would consider using cabotegravir for HIV prevention in the future and their answers to this question were recorded as 'Yes', 'No' or 'Missing'.
Time frame: Up to Week 41
Relationship Between Safety and Tolerability Parameters With Cabotegravir PK Parameters
Relationship between safety and tolerability parameters with cabotegravir PK parameters was planned to be analyzed.
Time frame: Up to Week 41
This was an open-label, multi-site study to evaluate pharmacokinetic (PK), safety, tolerability, and acceptability of long acting (LA) injections of cabotegravir (CAB) in human immunodeficieny virus (HIV) uninfected Chinese men.
| Milestone | Cabotegravir |
|---|---|
| Started | 48 |
| Completed | 47 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | Cabotegravir |
|---|---|
| Started | 47 |
| Completed | 47 |
| Not completed | 0 |
| Milestone | Cabotegravir |
|---|---|
| Started | 47 |
| Completed | 43 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 3 |
| Milestone | Cabotegravir |
|---|---|
| Started | 43 |
| Completed | 43 |
| Not completed | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or other situations as per investigator's judgement.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| Non-serious AEs | 47 |
| SAEs | 1 |
Hematology parameters were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: Activated partial thromboplastin time (APTT) prolonged, hemoglobin (Hb) (increased), white blood cells (WBC) (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| APTT prolonged, Grade 0, n=28 | 28 |
| APTT prolonged, Grade 1, n=28 | 0 |
| APTT prolonged, Grade 2, n=28 | 0 |
| APTT prolonged, Grade 3, n=28 | 0 |
| APTT prolonged, Grade 4, n=28 | 0 |
| Hb (increased), Grade 0, n=47 | 47 |
| Hb (increased), Grade 1, n=47 | 0 |
| Hb (increased), Grade 2, n=47 | 0 |
| Hb (increased), Grade 3, n=47 | 0 |
| Hb (increased), Grade 4, n=47 | 0 |
| WBC (decreased), Grade 0, n=47 | 47 |
| WBC (decreased), Grade 1, n=47 | 0 |
| WBC (decreased), Grade 2, n=47 | 0 |
| WBC (decreased), Grade 3, n=47 | 0 |
| WBC (decreased), Grade 4, n=47 | 0 |
| Lymphocytes count (decreased), Grade 0, n=47 | 47 |
| Lymphocytes count (decreased), Grade 1, n=47 | 0 |
| Lymphocytes count (decreased), Grade 2, n=47 | 0 |
| Lymphocytes count (decreased), Grade 3, n=47 | 0 |
| Lymphocytes count (decreased), Grade 4, n=47 | 0 |
| Neutrophils (decreased), Grade 0, n=47 | 47 |
| Neutrophils (decreased), Grade 1, n=47 | 0 |
| Neutrophils (decreased), Grade 2, n=47 | 0 |
| Neutrophils (decreased), Grade 3, n=47 | 0 |
| Neutrophils (decreased), Grade 4, n=47 | 0 |
| Platelets (decreased), Grade 0, n=47 | 45 |
| Platelets (decreased), Grade 1, n=47 | 2 |
| Platelets (decreased), Grade 2, n=47 | 0 |
| Platelets (decreased), Grade 3, n=47 | 0 |
| Platelets (decreased), Grade 4, n=47 | 0 |
| Prothrombin INR (increased), Grade 0, n=28 | 28 |
| Prothrombin INR (increased), Grade 1, n=28 | 0 |
| Prothrombin INR (increased), Grade 2, n=28 | 0 |
| Prothrombin INR (increased),Grade 3, n=28 | 0 |
| Prothrombin INR (increased), Grade 4, n=28 | 0 |
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), bilirubin, calcium (hypercalcemia and hypocalcemia), carbon dioxide (CO2) (decreased), cholesterol (high), Creatine phosphokinase (CPK) increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| ALT, Grade 0, n=47 | 41 |
| ALT, Grade 1, n=47 | 6 |
| ALT, Grade 2, n=47 | 0 |
| ALT, Grade 3, n=47 | 0 |
| ALT, Grade 4, n=47 | 0 |
| Albumin, Grade 0, n=47 | 47 |
| Albumin, Grade 1, n=47 | 0 |
| Albumin, Grade 2, n=47 | 0 |
| Albumin, Grade 3, n=47 | 0 |
| Albumin, Grade 4, n=47 | 0 |
| ALP, Grade 0, n=47 | 47 |
| ALP, Grade 1, n=47 | 0 |
| ALP, Grade 2, n=47 | 0 |
| ALP, Grade 3, n=47 | 0 |
| ALP, Grade 4, n=47 | 0 |
| AST, Grade 0, n=47 | 39 |
| AST, Grade 1, n=47 | 6 |
| AST, Grade 2, n=47 | 2 |
| AST, Grade 3, n=47 | 0 |
| AST, Grade 4, n=47 | 0 |
| Bilirubin, Grade 0, n=47 | 45 |
| Bilirubin, Grade 1, n=47 | 2 |
| Bilirubin, Grade 2, n=47 | 0 |
| Bilirubin, Grade 3, n=47 | 0 |
| Bilirubin, Grade 4, n=47 | 0 |
| Calcium, Hypercalcemia, Grade 0, n=47 | 47 |
| Calcium, Hypercalcemia, Grade 1, n=47 | 0 |
| Calcium, Hypercalcemia, Grade 2, n=47 | 0 |
| Calcium, Hypercalcemia, Grade 3, n=47 | 0 |
| Calcium, Hypercalcemia, Grade 4, n=47 | 0 |
| Calcium, Hypocalcemia, Grade 0, n=47 | 47 |
| Calcium, Hypocalcemia, Grade 1, n=47 | 0 |
| Calcium, Hypocalcemia, Grade 2, n=47 | 0 |
| Calcium, Hypocalcemia, Grade 3, n=47 | 0 |
| Calcium, Hypocalcemia, Grade 4, n=47 | 0 |
| CO2 decreased, Grade 0, n=47 | 47 |
| CO2 decreased, Grade 1, n=47 | 0 |
| CO2 decreased, Grade 2, n=47 | 0 |
| CO2 decreased Grade 3, n=47 | 0 |
| CO2 decreased, Grade 4, n=47 | 0 |
| Cholesterol (High), Grade 0, n=28 | 26 |
| Cholesterol (High), Grade 1, n=28 | 2 |
| Cholesterol (High), Grade 2, n=28 | 0 |
| Cholesterol (High), Grade 3, n=28 | 0 |
| Cholesterol (High), Grade 4, n=28 | 0 |
| CPK increased, Grade 0, n=47 | 38 |
| CPK increased, Grade 1, n=47 | 4 |
| CPK increased, Grade 2, n=47 | 0 |
| CPK increased, Grade 3, n=47 | 4 |
| CPK increased, Grade 4, n=47 | 1 |
| Creatinine increased, Grade 0, n=47 | 46 |
| Creatinine increased, Grade 1, n=47 | 1 |
| Creatinine increased, Grade 2, n=47 | 0 |
| Creatinine increased, Grade 3, n=47 | 0 |
| Creatinine increased, Grade 4, n=47 | 0 |
| Creatinine clearance decreased, Grade 0, n=47 | 31 |
| Creatinine clearance decreased, Grade 1, n=47 | 0 |
| Creatinine clearance decreased, Grade 2, n=47 | 16 |
| Creatinine clearance decreased, Grade 3, n=47 | 0 |
| Creatinine clearance decreased, Grade 4, n=47 | 0 |
| Glucose (hyperglycemia), Grade 0, n=47 | 38 |
| Glucose (hyperglycemia), Grade 1, n=47 | 7 |
| Glucose (hyperglycemia), Grade 2, n=47 | 2 |
| Glucose (hyperglycemia), Grade 3, n=47 | 0 |
| Glucose (hyperglycemia), Grade 4, n=47 | 0 |
| Glucose (hypoglycemia), Grade 0, n=47 | 46 |
| Glucose (hypoglycemia), Grade 1, n=47 | 1 |
| Glucose (hypoglycemia), Grade 2, n=47 | 0 |
| Glucose (hypoglycemia), Grade 3, n=47 | 0 |
| Glucose (hypoglycemia), Grade 4, n=47 | 0 |
| Hypophosphatemia, Grade 0, n=47 | 45 |
| Hypophosphatemia, Grade 1, n=47 | 2 |
| Hypophosphatemia, Grade 2, n=47 | 0 |
| Hypophosphatemia, Grade 3, n=47 | 0 |
| Hypophosphatemia, Grade 4, n=47 | 0 |
| Potassium (Hyperkalemia), Grade 0, n=47 | 47 |
| Potassium (Hyperkalemia), Grade 1, n=47 | 0 |
| Potassium (Hyperkalemia), Grade 2, n=47 | 0 |
| Potassium (Hyperkalemia), Grade 3, n=47 | 0 |
| Potassium (Hyperkalemia), Grade 4, n=47 | 0 |
| Potassium (Hypokalemia), Grade 0, n=47 | 47 |
| Potassium (Hypokalemia), Grade 1, n=47 | 0 |
| Potassium (Hypokalemia), Grade 2, n=47 | 0 |
| Potassium (Hypokalemia), Grade 3, n=47 | 0 |
| Potassium (Hypokalemia), Grade 4, n=47 | 0 |
| Sodium, hypernatremia, Grade 0, n=47 | 47 |
| Sodium, hypernatremia, Grade 1, n=47 | 0 |
| Sodium, hypernatremia, Grade 2, n=47 | 0 |
| Sodium, hypernatremia, Grade 3, n=47 | 0 |
| Sodium, hypernatremia, Grade 4, n=47 | 0 |
| Sodium, hyponatremia, Grade 0, n=47 | 47 |
| Sodium, hyponatremia, Grade 1, n=47 | 0 |
| Sodium, hyponatremia, Grade 2, n=47 | 0 |
| Sodium, hyponatremia, Grade 3, n=47 | 0 |
| Sodium, hyponatremia, Grade 4, n=47 | 0 |
| Hypertriglyceridemia, Grade 0, n=28 | 21 |
| Hypertriglyceridemia, Grade 1, n=28 | 6 |
| Hypertriglyceridemia, Grade 2, n=28 | 1 |
| Hypertriglyceridemia, Grade 3, n=28 | 0 |
| Hypertriglyceridemia, Grade 4, n=28 | 0 |
| Uric acid increased, Grade 0, n=47 | 32 |
| Uric acid increased, Grade 1, n=47 | 14 |
| Uric acid increased, Grade 2, n=47 | 1 |
| Uric acid increased ,Grade 3, n=47 | 0 |
| Uric acid increased, Grade 4, n=47 | 0 |
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| Protein, Grade 0 | 29 |
| Protein, Grade 1 | 0 |
| Protein, Grade 2 | 0 |
| Protein, Grade 3 | 0 |
| Protein, Grade 4 | 0 |
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: systolic blood pressure (SBP) (Low: \<85 millimeters of mercury \[mmHg\], High: \>160 mmHg), diastolic blood pressure (DBP) (Low: \<45 mmHg, High: \>100 mmHg), pulse rate (Low: \<40 mmHg, High: \>100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| SBP, To low | 0 |
| SBP, To Normal or No Change | 46 |
| SBP, To High | 1 |
| DBP, To low | 0 |
| DBP, To Normal or No Change | 46 |
| DBP, To High | 1 |
| Pulse rate, To low | 0 |
| Pulse rate, To Normal or No Change | 46 |
| Pulse rate, To High | 1 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| Number of Participants Withdrawn Due to AEs- Injection Phase | 0 |
Injection site reactions were recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) is presented.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| Number of Participants Experiencing Injection Site Reactions (ISR)-Injection Phase | 47 |
Blood samples were collected at the indicated time points for the determination of Ctau following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Micrograms per milliliter | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Concentration of Cabotegravir in Plasma at the End of the Dosing Interval (Ctau)-Oral lead-in Phase | 6.807 ± 26.8 |
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Hour*micrograms per milliliter | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Dosing of Cabotegravir-Oral lead-in Phase | 191.1 ± 20.5 |
Blood samples were collected at the indicated time points for the determination of Cmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Micrograms per milliliter | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Maximum Observed Concentration (Cmax) Following Oral Dosing With Cabogegravir-Oral lead-in Phase | 10.447 ± 19.5 |
Blood samples were collected at the indicated time points for the determination of Tmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Hours | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Time of Occurrence of Cmax (Tmax) Following Oral Dosing With Cabotegravir-Oral lead-in Phase | 2.0000 (0.983 to 4.000) |
Blood samples were collected at the indicated time points for the determination of CL/F following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Liters per hour | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Apparent Clearance Following Oral Dosing (CL/F) Following Dosing With Cabotegravir-Oral lead-in Phase | 0.1570 ± 20.5 |
Blood samples were collected at the indicated time points for the determination of t1/2 following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Hours | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Terminal Absorption Elimination Half-life (t1/2) Following Oral Dosing With Cabotegravir-Oral lead-in Phase | 45.24 ± 20.5 |
Blood samples were collected at the indicated time points for the determination of Lambda z following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Per hour | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Apparent Terminal Phase Rate Constant (Lambda z) Following Oral Dosing With Cabotegravir-Oral lead-in Phase | 0.01532 ± 20.5 |
Blood samples were collected at the indicated time points for the determination of Vss following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
| Liters | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Volume of Distribution at Steady State (Vss) Following Oral Dosing With Cabotegravir-Oral lead-in Phase | 10.246 ± 17.8 |
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Micrograms per milliliter | CAB LA 600 mg (Injection Phase) |
|---|---|
| Ctau Following IM Dosing With CAB LA During Injection Phase | 1.5831 ± 43.1 |
Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Hour*micrograms per milliliter | CAB LA 600 mg (Injection Phase) |
|---|---|
| AUC(0-tau) Following IM Dosing With CAB LA During Injection Phase | 3415.1 ± 41.9 |
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Micrograms per milliliter | CAB LA 600 mg (Injection Phase) |
|---|---|
| Cmax Following IM Dosing With CAB LA During Injection Phase | 3.730 ± 66.1 |
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Hour | CAB LA 600 mg (Injection Phase) |
|---|---|
| Tmax Following IM Dosing With CAB LA During Injection Phase | 167.433 (0.00 to 765.25) |
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Micrograms per milliliter | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| Ctau Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 1.5831 ± 43.1 |
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Hour*micrograms per milliliter | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| AUC(0-tau) Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 3442.5 ± 41.1 |
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Micrograms per milliliter | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| Cmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 3.730 ± 66.1 |
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Hour | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| Tmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 167.433 (0.00 to 765.25) |
Blood samples were collected at the indicated time points for the determination of CL/F following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Liters per hour | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| CL/F Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 0.17429 ± 41.1 |
Blood samples were collected at the indicated time points for the determination of t1/2 following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Hour | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| T1/2 Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 1128.6 ± 71.2 |
Blood samples were collected at the indicated time points for the determination of Lambda z following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Per hour | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| Lambda z Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 0.0006141 ± 71.2 |
Blood samples were collected at the indicated time points for the determination of Vss following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
| Liters | CAB LA 600 mg (Injection Phase and Long-term Follow up) |
|---|---|
| Vss Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases | 282.44 ± 124.8 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity, Is a congenital anomaly/birth defect, other situation as per investigator's judgement.
| Participants | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Non-serious AEs | 13 |
| SAEs | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
| Participants | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Number of Participants Withdrawn Due to AEs-oral lead-in Phase | 1 |
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included ALT, albumin, ALP, AST, bilirubin, calcium (hypercalcemia and hypocalcemia), CO2 decreased, cholesterol, CPK increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
| Participants | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| ALT, Grade 0, n=48 | 45 |
| ALT, Grade 1, n=48 | 3 |
| ALT, Grade 2, n=48 | 0 |
| ALT, Grade 3, n=48 | 0 |
| ALT, Grade 4, n=48 | 0 |
| Albumin, Grade 0, n=48 | 48 |
| Albumin, Grade 1, n=48 | 0 |
| Albumin, Grade 2, n=48 | 0 |
| Albumin, Grade 3, n=48 | 0 |
| Albumin, Grade 4, n=48 | 0 |
| ALP, Grade 0, n=48 | 48 |
| ALP, Grade 1, n=48 | 0 |
| ALP, Grade 2, n=48 | 0 |
| ALP, Grade 3, n=48 | 0 |
| ALP, Grade 4, n=48 | 0 |
| AST, Grade 0, n=48 | 47 |
| AST, Grade 1, n=48 | 1 |
| AST, Grade 2, n=48 | 0 |
| AST, Grade 3, n=48 | 0 |
| AST, Grade 4, n=48 | 0 |
| Bilirubin, Grade 0, n=48 | 48 |
| Bilirubin, Grade 1, n=48 | 0 |
| Bilirubin, Grade 2, n=48 | 0 |
| Bilirubin, Grade 3, n=48 | 0 |
| Bilirubin, Grade 4, n=48 | 0 |
| Calcium, Hypercalcemia, Grade 0, n=48 | 48 |
| Calcium, Hypercalcemia, Grade 1, n=48 | 0 |
| Calcium, Hypercalcemia, Grade 2, n=48 | 0 |
| Calcium, Hypercalcemia, Grade 3, n=48 | 0 |
| Calcium, Hypercalcemia, Grade 4, n=48 | 0 |
| Calcium, Hypocalcemia, Grade 0, n=48 | 48 |
| Calcium, Hypocalcemia, Grade 1, n=48 | 0 |
| Calcium, Hypocalcemia, Grade 2, n=48 | 0 |
| Calcium, Hypocalcemia, Grade 3, n=48 | 0 |
| Calcium, Hypocalcemia, Grade 4, n=48 | 0 |
| CO2 decreased, Grade 0, n=48 | 47 |
| CO2 decreased, Grade 1, n=48 | 1 |
| CO2 decreased, Grade 2, n=48 | 0 |
| CO2 decreased, Grade 3, n=48 | 0 |
| CO2 decreased, Grade 4, n=48 | 0 |
| Cholesterol (High), Grade 0, n=3 | 3 |
| Cholesterol (High), Grade 1, n=3 | 0 |
| Cholesterol (High), Grade 2, n=3 | 0 |
| Cholesterol (High), Grade 3, n=3 | 0 |
| Cholesterol (High), Grade 4, n=3 | 0 |
| CPK increased, Grade 0, n=48 | 48 |
| CPK increased, Grade 1, n=48 | 0 |
| CPK increased, Grade 2, n=48 | 0 |
| CPK increased, Grade 3, n=48 | 0 |
| CPK increased, Grade 4, n=48 | 0 |
| Creatinine increased, Grade 0, n=48 | 48 |
| Creatinine increased, Grade 1, n=48 | 0 |
| Creatinine increased, Grade 2, n=48 | 0 |
| Creatinine increased, Grade 3, n=48 | 0 |
| Creatinine increased, Grade 4, n=48 | 0 |
| Creatinine clearance decreased, Grade 0, n=48 | 39 |
| Creatinine clearance decreased, Grade 1, n=48 | 0 |
| Creatinine clearance decreased, Grade 2, n=48 | 9 |
| Creatinine clearance decreased, Grade 3, n=48 | 0 |
| Creatinine clearance decreased, Grade 4, n=48 | 0 |
| Glucose (hyperglycemia), Grade 0, n=48 | 41 |
| Glucose (hyperglycemia), Grade 1, n=48 | 7 |
| Glucose (hyperglycemia), Grade 2, n=48 | 0 |
| Glucose (hyperglycemia), Grade 3, n=48 | 0 |
| Glucose (hyperglycemia), Grade 4, n=48 | 0 |
| Glucose (hypoglycemia), Grade 0, n=48 | 48 |
| Glucose (hypoglycemia), Grade 1, n=48 | 0 |
| Glucose (hypoglycemia), Grade 2, n=48 | 0 |
| Glucose (hypoglycemia), Grade 3, n=48 | 0 |
| Glucose (hypoglycemia), Grade 4, n=48 | 0 |
| Hypophosphatemia, Grade 0, n=48 | 46 |
| Hypophosphatemia, Grade 1, n=48 | 2 |
| Hypophosphatemia, Grade 2, n=48 | 0 |
| Hypophosphatemia, Grade 3, n=48 | 0 |
| Hypophosphatemia, Grade 4, n=48 | 0 |
| Potassium (Hyperkalemia), Grade 0, n=48 | 48 |
| Potassium (Hyperkalemia), Grade 1, n=48 | 0 |
| Potassium (Hyperkalemia), Grade 2, n=48 | 0 |
| Potassium (Hyperkalemia), Grade 3, n=48 | 0 |
| Potassium (Hyperkalemia), Grade 4, n=48 | 0 |
| Potassium (Hypokalemia), Grade 0, n=48 | 48 |
| Potassium (Hypokalemia), Grade 1, n=48 | 0 |
| Potassium (Hypokalemia), Grade 2, n=48 | 0 |
| Potassium (Hypokalemia), Grade 3, n=48 | 0 |
| Potassium (Hypokalemia), Grade 4, n=48 | 0 |
| Sodium, hypernatremia, Grade 0, n=48 | 48 |
| Sodium, hypernatremia, Grade 1, n=48 | 0 |
| Sodium, hypernatremia, Grade 2, n=48 | 0 |
| Sodium, hypernatremia, Grade 3, n=48 | 0 |
| Sodium, hypernatremia, Grade 4, n=48 | 0 |
| Sodium, hyponatremia, Grade 0, n=48 | 48 |
| Sodium, hyponatremia, Grade 1, n=48 | 0 |
| Sodium, hyponatremia, Grade 2, n=48 | 0 |
| Sodium, hyponatremia, Grade 3, n=48 | 0 |
| Sodium, hyponatremia, Grade 4, n=48 | 0 |
| Hypertriglyceridemia, Grade 0, n=3 | 2 |
| Hypertriglyceridemia, Grade 1, n=3 | 1 |
| Hypertriglyceridemia, Grade 2, n=3 | 0 |
| Hypertriglyceridemia, Grade 3, n=3 | 0 |
| Hypertriglyceridemia, Grade 4, n=3 | 0 |
| Uric acid increased, Grade 0, n=48 | 42 |
| Uric acid increased, Grade 1, n=48 | 6 |
| Uric acid increased, Grade 2, n=48 | 0 |
| Uric acid increased, Grade 3, n=48 | 0 |
| Uric acid increased, Grade 4, n=48 | 0 |
Hematology parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: APTT prolonged, Hb (increased), WBC (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
| Participants | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| APTT prolonged, Grade 0 | 48 |
| APTT prolonged, Grade 1 | 0 |
| APTT prolonged, Grade2 | 0 |
| APTT prolonged, Grade 3 | 0 |
| APTT prolonged, Grade 4 | 0 |
| Hb (increased), Grade 0 | 48 |
| Hb (increased), Grade 1 | 0 |
| Hb (increased), Grade 2 | 0 |
| Hb (increased), Grade 3 | 0 |
| Hb (increased), Grade 4 | 0 |
| WBC (decreased), Grade 0 | 48 |
| WBC (decreased), Grade 1 | 0 |
| WBC (decreased), Grade 2 | 0 |
| WBC (decreased), Grade 3 | 0 |
| WBC (decreased), Grade 4 | 0 |
| Lymphocytes count (decreased), Grade 0 | 48 |
| Lymphocytes count (decreased), Grade 1 | 0 |
| Lymphocytes count (decreased), Grade 2 | 0 |
| Lymphocytes count (decreased), Grade 3 | 0 |
| Lymphocytes count (decreased), Grade 4 | 0 |
| Neutrophils (decreased), Grade 0 | 48 |
| Neutrophils (decreased), Grade 1 | 0 |
| Neutrophils (decreased), Grade 2 | 0 |
| Neutrophils (decreased), Grade 3 | 0 |
| Neutrophils (decreased), Grade 4 | 0 |
| Platelets (decreased), Grade 0 | 47 |
| Platelets (decreased), Grade 1 | 1 |
| Platelets (decreased), Grade 2 | 0 |
| Platelets (decreased), Grade 3 | 0 |
| Platelets (decreased), Grade 4 | 0 |
| Prothrombin INR (increased), Grade 0 | 48 |
| Prothrombin INR (increased), Grade 1 | 0 |
| Prothrombin INR (increased), Grade 2 | 0 |
| Prothrombin INR (increased), Grade 3 | 0 |
| Prothrombin INR (increased), Grade 4 | 0 |
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
| Participants | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| Protein, Grade 0 | 48 |
| Protein, Grade 1 | 0 |
| Protein, Grade 2 | 0 |
| Protein, Grade 3 | 0 |
| Protein, Grade 4 | 0 |
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: SBP (Low \<85 mmHg, High: \>160 mmHg), DBP (Low: \<45 mmHg, High: \>100 mmHg), pulse rate (Low: \<40 mmHg, High: \>100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
| Participants | CAB 30 mg (Oral lead-in Phase) |
|---|---|
| SBP, To low | 0 |
| SBP, To Normal or No Change | 48 |
| SBP, To High | 0 |
| DBP, To low | 0 |
| DBP, To Normal or No Change | 48 |
| DBP, To High | 0 |
| Pulse rate, To low | 0 |
| Pulse rate, To Normal or No Change | 48 |
| Pulse rate, To High | 0 |
Percentage of participants with injection discontinuation is presented.
| Percentage of participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| Percentage of Participants With Injection Discontinuation-Injection Phase | 4 |
Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity is categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated. Higher grade indicates more severe condition. Number of participants who had at least one Grade 2 to 4 Injection site reaction is presented.
| Participants | CAB LA 600 mg (Injection Phase) |
|---|---|
| Number of Participants With Grade 2 to 4 Injection Site Pain-Injection Phase | 18 |
HIV-Prevention Treatment Satisfaction Questionnaire (change) (HIV-PrevTSQc) was used to assess participant tolerability and satisfaction to the treatment. It consisted total 13 questions. The experience of HIV prevention treatment was assessed using a scale from 3 (much more satisfied/effective/convenient/ flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now) to -3 (much less satisfied/effective/convenient/flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now). Total score was calculated by taking sum of scores of all questions. It ranges from -39 to 39, with higher scores indicating more satisfaction.
| Scores on scale | CAB LA 600 mg (Injection Phase) |
|---|---|
| HIV-Prevention Treatment Satisfaction Total Score-Injection Phase | 23.7 ± 8.55 |
Number of participants who consider using cabotegravir for HIV prevention in the future is presented. Participants were asked if they would consider using cabotegravir for HIV prevention in the future and their answers to this question were recorded as 'Yes', 'No' or 'Missing'.
| Participants | Cabotegravir |
|---|---|
| Yes | 40 |
| No | 7 |
| Missing | 1 |
Relationship between safety and tolerability parameters with cabotegravir PK parameters was planned to be analyzed.
No measurements were reported for this outcome.
Collected over Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAB 30 mg - Oral lead-in Phase | 0/48 (0%) | 0/48 (0%) | 13/48 (27.1%) |
| CAB LA 600 mg - Injection Phase | 0/47 (0%) | 1/47 (2.1%) | 47/47 (100%) |
| CAB LA 600 mg - Long-term Follow-up Phase | 0/47 (0%) | 0/47 (0%) | 17/47 (36.2%) |
| Event | CAB 30 mg - Oral lead-in Phase | CAB LA 600 mg - Injection Phase | CAB LA 600 mg - Long-term Follow-up Phase |
|---|---|---|---|
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/48 | 1/47 | 0/47 |
| Event | CAB 30 mg - Oral lead-in Phase | CAB LA 600 mg - Injection Phase | CAB LA 600 mg - Long-term Follow-up Phase |
|---|---|---|---|
| Injection site painGeneral disorders | 0/48 | 47/47 | 0/47 |
| Injection site swellingGeneral disorders | 0/48 | 22/47 | 0/47 |
| Upper respiratory tract infectionInfections and infestations | 4/48 | 15/47 | 9/47 |
| PyrexiaGeneral disorders | 0/48 | 9/47 | 2/47 |
| Injection site indurationGeneral disorders | 0/48 | 4/47 | 0/47 |
| HeadacheNervous system disorders | 1/48 | 4/47 | 0/47 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/48 | 4/47 | 0/47 |
| Alanine aminotransferase increasedInvestigations | 1/48 | 2/47 | 4/47 |
| Blood uric acid increasedInvestigations | 1/48 | 4/47 | 2/47 |
| Injection site pruritusGeneral disorders | 0/48 | 3/47 | 0/47 |
| Age, Continuous(Years) | Cabotegravir |
|---|---|
| Mean | 31.1 ± 8.11 |
| Sex: Female, Male(Participants) | Cabotegravir |
|---|---|
| Female | 0 |
| Male | 48 |
| Race/Ethnicity, Customized(Participants) | Cabotegravir |
|---|---|
| Asian - East Asian Heritage | 48 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Apr 2018 to primary completion in Apr 2020, 24 months.
Results were first posted in May 2021, 1 year after primary completion.
Of 74 industry-sponsored phase 1 interventional studies under HIV Infections, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 24 months is above that.
Counting every sponsor, half of 165 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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