A Phase 3 interventional study of Dolutegravir and Emtricitabine/tenofovir alafenamide in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 21 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Treatment
Among 55 studies testing dolutegravir in HIV Infections — 7 open to participants now, 9 under way, 4 of them phase 3. Dolutegravir · HIV Infections.
Among the 55 studies testing dolutegravir in HIV Infections, this one is the 8th largest by enrollment, is one of 3 that started in 2018, is one of 21 in phase 3, and was the 27th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 643 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →7 of the 55 studies testing dolutegravir in HIV Infections are open now, in 12 countries. Each count lists the studies.
Dolutegravir: first FDA approval 2013 (TIVICAY), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →55 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2018.
Median enrollment 126 across the 55 interventional studies. Of the 43 that completed or were terminated, 26 (60%) have results posted.
28 of 55 have an industry lead sponsor. The 10 most frequent:
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.
1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID): 10 open now, 15 under way, 1 of them phase 3. Of 962 finished, 130 (14%) have results posted.
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 81st largest by enrollment of the 883 interventional ones, is one of 11 that started in 2018, is one of 96 in phase 3, and was the 970th registered.
National Institute of Allergy and Infectious Diseases (NIAID)’s HIV Infections studies by the year they started, since 1984.
1 of the studies testing dolutegravir in HIV Infections that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07031063Instituto Mexicano del Seguro SocialSafety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience | 2026-12-01 |
Among the 55 studies testing dolutegravir in HIV Infections, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among National Institute of Allergy and Infectious Diseases (NIAID)’s 1,034 in HIV Infections:
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.
This study compared the virologic efficacy and safety of three ARV regimens in pregnant women living with HIV: dolutegravir (DTG) plus emtricitabine/tenofovir alafenamide (FTC/TAF), DTG plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). The study also compared the safety of these regimens for their infants.
At study entry, mothers were randomly assigned to either receive DTG plus FTC/TAF (Arm 1), DTG plus FTC/TDF (Arm 2), or EFV/FTC/TDF (Arm 3) during pregnancy, through delivery, and for 50 weeks postpartum.
Mothers completed study visits at study entry and every four weeks during pregnancy. Study visits for mothers and their infants occurred at delivery and at 6, 14, 26, 38, and 50 weeks postpartum. Visits for mothers and infants included physical examinations and blood collection. Select study visits also included breast milk collection from mothers who breastfed, hair and urine collection, ultrasound scans, pregnancy testing, contraception counseling, and, for a subset of participants, dual energy x-ray absorptiometry (DXA) scans for mothers and their infants.
For pregnancy outcome measures, mothers and infants were evaluated together as mother-infant pairs, with any outcome between the two counting as an event (for example, if an infant was born small for gestational age, this would be a pregnancy outcome event for the mother-infant pair). For all other outcome measures, women and infants were evaluated separately.
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.
Mother has confirmed -1 infection based on documented testing of two samples collected at different time points:
At screening, mother has the following laboratory test results (based on testing of samples collected within 14 days prior to study entry):
At study entry, mother reports that she does not wish to become pregnant again for at least 50 weeks after her current pregnancy and that she is willing to use effective during this period. Effective contraception may include surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) or any of the following methods:
Exclusion Criteria:
Mother is currently receiving:
Mother has a history of any of the following, as determined by the site investigator or designee based on maternal report and available medical records:
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Mothers randomized to receive dolutegravir (DTG) plus emtricitabine/tenofovir alafenamide (FTC/TAF) during pregnancy, through delivery, and for 50 weeks postpartum.
Drug: Dolutegravir · Drug: Emtricitabine/tenofovir alafenamide
Mothers randomized to receive DTG plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) during pregnancy, through delivery, and for 50 weeks postpartum.
Drug: Dolutegravir · Drug: Emtricitabine/tenofovir disoproxil fumarate
Mothers randomized to receive efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) during pregnancy, through delivery, and for 50 weeks postpartum.
Drug: Efavirenz/emtricitabine/tenofovir disoproxil fumarate
Infants born to women in Arm 1. Infants did not directly receive study intervention, but may have been exposed to the randomized treatment through placental or breastmilk transfer.
Infants born to women in Arm 2. Infants did not directly receive study intervention, but may have been exposed to the randomized treatment through placental or breastmilk transfer.
Infants born to women in Arm 3. Infants did not directly receive study intervention, but may have been exposed to the randomized treatment through placental or breastmilk transfer.
One 50 mg DTG tablet was administered orally once daily
Also known as: DTG
Drug page: Emtricitabine tenofovir alafenamide
One fixed-dose combination tablet (FTC 200 mg/TAF 25 mg) was administered orally once daily
Also known as: FTC/TAF
One fixed-dose combination tablet (FTC 200 mg/TDF 300 mg) was administered orally once daily
Also known as: FTC/TDF
One fixed-dose combination tablet (EFV 600 mg/FTC 200 mg/TDF 300 mg) was administered orally once daily
Also known as: EFV/FTC/TDF
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication.
Time frame: Delivery
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile by INTERGROWTH 21st Standards)
Time frame: Delivery
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks.
Time frame: From randomization up to 74 weeks
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.
Time frame: From birth through Week 50 postpartum
Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory
Time frame: Delivery
Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum
Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories
Time frame: 50 weeks postpartum
Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories
Time frame: Randomization to delivery
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories
Time frame: Delivery
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories
Time frame: 50 weeks postpartum
Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile per INTERGROWTH 21st Standards)
Time frame: Delivery
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks.
Time frame: From randomization up to 74 weeks
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.
Time frame: Birth through Week 50 postpartum
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly
Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (\<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (\<37 weeks gestation), and infants small for gestational age (\<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm.
Time frame: Delivery through 50 weeks postpartum
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome
Infant and pregnancy outcomes were classified on a scale of 1 to 10, with mother-infant pairs categorized by the worst outcome they experienced (worst category being 1 and best being 10): 1) Infant death; 2) Spontaneous abortion (\<20 weeks gestation) or stillbirth (≥20 weeks gestation); 3) Infant HIV infection; 4) Extremely and very early preterm (\<32 completed weeks); 5) Major congenital anomaly; 6) Preterm delivery (\<37 completed weeks); 7) Small for gestational age (\<10th percentile); 8) Infant hospitalization; 9) Infant grade 3 or 4 adverse event; 10) None of the above. If a mother-infant pair experienced more than one safety outcome, only the worst was reported.
Time frame: Birth through 50 weeks postpartum
Cumulative Probability of Infant HIV-infection
The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results.
Time frame: Birth through 50 weeks after birth
Cumulative Probability of Infant Deaths
The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth.
Time frame: Birth through 50 weeks after birth
Maternal Change in Creatinine Clearance
Maternal change in creatinine clearance per week based on generalized estimating equations
Time frame: Baseline to 50 weeks postpartum
Infant Creatinine Clearance
Infant creatinine clearance based on Schwartz formula
Time frame: Delivery and 26 weeks postpartum
Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads \<200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations.
Time frame: From 24 weeks after randomization through Week 50 postpartum
Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis
Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results.
Time frame: From birth through 50 weeks postpartum
Percentage of Mother-Infant Pairs With Preterm Deliveries
Percentage of mother-infant pairs with preterm deliveries (\<37 weeks gestation) resulting in live born infant
Time frame: Delivery
Percentage of Infants Born Small for Gestational Age
Percentage of infants born small for gestational age (\<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards
Time frame: Birth
Change in Maternal Weight Antepartum
Change in maternal antepartum weight per week based on generalized estimating equations
Time frame: Baseline through before delivery (up to one day prior)
Change in Maternal Weight Postpartum
Change in maternal postpartum weight per week based on generalized estimating equations
Time frame: Delivery to 50 weeks postpartum
Change in Maternal Weight Overall
Change in maternal weight per week based on generalized estimating equations
Time frame: Baseline to 50 weeks postpartum
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery by Race
NIH-required analysis. Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories by race using an intention-to-treat analysis. Statistical analyses could not be done the subgroups of Asian and White women due to small sample sizes and no participants with viral load equal or greater than 200 copies/mL in these groups.
Time frame: Delivery
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome by Maternal Race
NIH-required analysis. Percentage of mother-infant pairs with an adverse pregnancy outcome by maternal race. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile by INTERGROWTH 21st Standards) Statistical analyses could not be done in the subgroup of pairs with mothers categorized as Other race due to small sample sizes.
Time frame: Delivery
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event by Race
NIH-required analysis. The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause by race. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks. Statistical analyses could not be done among the subgroup of Asian women due to small sample sizes.
Time frame: From randomization up to 74 weeks
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event by Race
NIH-required analysis. The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause, by race. Statistical analyses could not be done among the subgroups of infants with Asian, White, and Other race due to small sample sizes and insufficient number of participants with events.
Time frame: From birth through Week 50 postpartum
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event by Sex
NIH-required analysis. The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause by sex.
Time frame: From birth through Week 50 postpartum
| Milestone | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Started | 217 | 215 | 211 |
| Completed | 200 | 205 | 202 |
| Not completed | 17 | 10 | 9 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 5 | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 7 | 4 |
| Withdrew: Moved | 3 | 2 | 2 |
| Withdrew: Noncompliant with study requirements | 2 | 1 | 2 |
| Withdrew: Not able to get to clinic | 1 | 0 | 0 |
Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication.
| Percentage of participants | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Intention-to-Treat Analysis | 97.5 | 91.0 |
| Per-Protocol Analysis | 97.5 | 91.4 |
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile by INTERGROWTH 21st Standards)
| percentage of mother-infant pairs | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome | 24.1 | 32.9 | 32.7 |
The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks.
| Cumulative probability per 100 persons | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | 25.1 | 30.8 | 27.9 |
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.
| Cumulative probability per 100 persons | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event | 25.3 | 28.6 | 30.9 |
Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory
| percentage of participants | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory | 94.4 | 78.8 |
Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories
| percentage of participants | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum | 96.3 | 96.4 |
Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories
| weeks | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery | 4.26 ± 0.09 | 6.49 ± 0.31 |
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories
| percentage of participants | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm | 88.9 | 92.6 | 81.0 |
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories
| percentage of participants | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm | 75.6 | 77.7 | 76.3 |
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile per INTERGROWTH 21st Standards)
| percentage of mother-infant pairs | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome | 28.4 | 32.7 |
The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks.
| Cumulative probability per 100 persons | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event | 27.9 | 27.9 |
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.
| Cumulative probability per 100 persons | Arms 1 and 2 Infants | Arm 3 Infants |
|---|---|---|
| Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event | 26.8 | 30.9 |
Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (\<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (\<37 weeks gestation), and infants small for gestational age (\<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm.
| percentage of mother-infant pairs | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly | 24.1 | 32.9 | 33.2 |
Infant and pregnancy outcomes were classified on a scale of 1 to 10, with mother-infant pairs categorized by the worst outcome they experienced (worst category being 1 and best being 10): 1) Infant death; 2) Spontaneous abortion (\<20 weeks gestation) or stillbirth (≥20 weeks gestation); 3) Infant HIV infection; 4) Extremely and very early preterm (\<32 completed weeks); 5) Major congenital anomaly; 6) Preterm delivery (\<37 completed weeks); 7) Small for gestational age (\<10th percentile); 8) Infant hospitalization; 9) Infant grade 3 or 4 adverse event; 10) None of the above. If a mother-infant pair experienced more than one safety outcome, only the worst was reported.
| Participants | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Infant Death | 2 | 4 | 14 |
| Spontaneous abortion or stillbirth | 8 | 11 | 4 |
| HIV-1 Infection | 2 | 0 | 1 |
| Extremely and Very Preterm Delivery | 1 | 1 | 2 |
| Major Congenital Anomaly | 2 | 0 | 1 |
| Preterm Delivery | 10 | 17 | 18 |
| Small for Gestational Age | 29 | 38 | 36 |
| Infant Hospitalization | 18 | 14 | 19 |
| Infant Grade 3 or 4 Adverse Event | 7 | 8 | 6 |
| None | 137 | 120 | 110 |
The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results.
| Cumulative probability per 100 persons | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Cumulative Probability of Infant HIV-infection | 0.98 | 0.50 | 0.55 |
The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth.
| Cumulative probability per 100 persons | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Cumulative Probability of Infant Deaths | 1.0 | 2.0 | 6.9 |
Maternal change in creatinine clearance per week based on generalized estimating equations
| mL/min | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Maternal Change in Creatinine Clearance | -0.980 (-1.066 to -0.894) | -0.887 (-0.964 to -0.810) | -0.935 (-1.013 to -0.857) |
Infant creatinine clearance based on Schwartz formula
| mL/min | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Delivery | 52.7 ± 29.6 | 53.1 ± 69.7 | 49.0 ± 24.7 |
| 26 Weeks Postpartum | 134.8 ± 109.6 | 123.6 ± 40.3 | 135.0 ± 51.1 |
Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads \<200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations.
| percentage of participants | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure | 0.92 | 1.86 | 6.16 |
Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results.
| Participants | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis | 1 | 0 | 1 |
Percentage of mother-infant pairs with preterm deliveries (\<37 weeks gestation) resulting in live born infant
| percentage of participants | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Percentage of Mother-Infant Pairs With Preterm Deliveries | 5.8 | 9.4 | 12.1 |
Percentage of infants born small for gestational age (\<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards
| percentage of participants | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Percentage of Infants Born Small for Gestational Age | 16.3 | 22.5 | 20.5 |
Change in maternal antepartum weight per week based on generalized estimating equations
| kg/week | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Change in Maternal Weight Antepartum | 0.378 (0.343 to 0.412) | 0.319 (0.291 to 0.348) | 0.291 (0.260 to 0.322) |
Change in maternal postpartum weight per week based on generalized estimating equations
| kg/week | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Change in Maternal Weight Postpartum | 0.014 (-0.004 to 0.032) | -0.008 (-0.027 to 0.012) | -0.032 (-0.048 to -0.017) |
Change in maternal weight per week based on generalized estimating equations
| kg/week | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Change in Maternal Weight Overall | -0.027 (-0.042 to -0.012) | -0.050 (-0.066 to -0.034) | -0.084 (-0.098 to -0.070) |
NIH-required analysis. Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories by race using an intention-to-treat analysis. Statistical analyses could not be done the subgroups of Asian and White women due to small sample sizes and no participants with viral load equal or greater than 200 copies/mL in these groups.
| Percentage | Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|
| Black or African American | 97.3 | 90.7 |
| Asian | 100.0 | 100.0 |
| White | 100.0 | 100.0 |
| Other | 100.0 | 75.0 |
NIH-required analysis. Percentage of mother-infant pairs with an adverse pregnancy outcome by maternal race. Adverse pregnancy outcome includes spontaneous abortion (\<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (\<37 completed weeks), or small for gestational age (\<10th percentile by INTERGROWTH 21st Standards) Statistical analyses could not be done in the subgroup of pairs with mothers categorized as Other race due to small sample sizes.
| Percentage | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Black or African American | 25.3 | 33.5 | 30.9 |
| Asian | 42.9 | 40.0 | 50.0 |
| White | 0.0 | 42.9 | 42.9 |
| Other | 0.0 | 0.0 | 75.0 |
NIH-required analysis. The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause by race. Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks. Statistical analyses could not be done among the subgroup of Asian women due to small sample sizes.
| Cumulative probability per 100 persons | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF |
|---|---|---|---|
| Black or African American | 26.4 | 30.2 | 26.2 |
| Asian | NA | 20.0 | 16.7 |
| White | 20.0 | 28.6 | 57.1 |
| Other | 10.0 | 50.0 | 75.0 |
NIH-required analysis. The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause, by race. Statistical analyses could not be done among the subgroups of infants with Asian, White, and Other race due to small sample sizes and insufficient number of participants with events.
| Cumulative probability per 100 persons | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Black or African American | 23.4 | 28.3 | 30.8 |
| Asian | NA | 40.0 | NA |
| White | 20.0 | NA | 42.9 |
| Other | 60.0 | NA | NA |
NIH-required analysis. The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause by sex.
| Cumulative probability per 100 persons | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|
| Female | 17.8 | 24.8 | 34.1 |
| Male | 32.3 | 33.1 | 27.2 |
Collected over For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 1/217 (0.5%) | 39/217 (18%) | 189/217 (87.1%) |
| Arm 2: Maternal DTG+FTC/TDF | 0/215 (0%) | 39/215 (18.1%) | 198/215 (92.1%) |
| Arm 3: Maternal EFV/FTC/TDF | 0/211 (0%) | 40/211 (19%) | 143/211 (67.8%) |
| Arm 1 Infants | 2/208 (1%) | 35/208 (16.8%) | 34/208 (16.3%) |
| Arm 2 Infants | 4/202 (2%) | 29/202 (14.4%) | 40/202 (19.8%) |
| Arm 3 Infants | 14/207 (6.8%) | 44/207 (21.3%) | 34/207 (16.4%) |
| Event | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|---|---|---|
| Sepsis neonatalInfections and infestations | 0/217 | 0/215 | 0/211 | 4/208 | 7/202 | 6/207 |
| Gestational hypertensionPregnancy, puerperium and perinatal conditions | 4/217 | 5/215 | 7/211 | 0/208 | 0/202 | 0/207 |
| Foetal deathPregnancy, puerperium and perinatal conditions | 6/217 | 7/215 | 1/211 | 0/208 | 0/202 | 0/207 |
| Premature babyPregnancy, puerperium and perinatal conditions | 0/217 | 0/215 | 0/211 | 1/208 | 5/202 | 4/207 |
| PneumoniaInfections and infestations | 0/217 | 0/215 | 1/211 | 4/208 | 2/202 | 5/207 |
| Hypoxic-ischaemic encephalopathyNervous system disorders | 0/217 | 0/215 | 0/211 | 2/208 | 0/202 | 5/207 |
| Meconium aspiration syndromeRespiratory, thoracic and mediastinal disorders | 0/217 | 0/215 | 0/211 | 2/208 | 1/202 | 5/207 |
| Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/217 | 0/215 | 0/211 | 5/208 | 2/202 | 2/207 |
| Foetal distress syndromePregnancy, puerperium and perinatal conditions | 2/217 | 2/215 | 5/211 | 0/208 | 0/202 | 0/207 |
| Preterm premature rupture of membranesPregnancy, puerperium and perinatal conditions | 2/217 | 3/215 | 4/211 | 0/208 | 0/202 | 0/207 |
| Event | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Arm 1 Infants | Arm 2 Infants | Arm 3 Infants |
|---|---|---|---|---|---|---|
| Creatinine renal clearance decreasedInvestigations | 182/217 | 193/215 | 132/211 | 0/208 | 0/202 | 0/207 |
| Blood creatinine increasedInvestigations | 170/217 | 179/215 | 76/211 | 4/208 | 8/202 | 4/207 |
| Haemoglobin decreasedInvestigations | 8/217 | 20/215 | 14/211 | 8/208 | 8/202 | 7/207 |
| Neutrophil count decreasedInvestigations | 0/217 | 0/215 | 2/211 | 10/208 | 7/202 | 14/207 |
| Alanine aminotransferase increasedInvestigations | 5/217 | 6/215 | 4/211 | 0/208 | 0/202 | 0/207 |
| Blood glucose decreasedInvestigations | 0/217 | 0/215 | 0/211 | 3/208 | 2/202 | 4/207 |
| Aspartate aminotransferase increasedInvestigations | 3/217 | 4/215 | 4/211 | 0/208 | 0/202 | 0/207 |
| Platelet count decreasedInvestigations | 1/217 | 0/215 | 1/211 | 0/208 | 3/202 | 0/207 |
| AnaemiaBlood and lymphatic system disorders | 0/217 | 1/215 | 3/211 | 0/208 | 0/202 | 1/207 |
| Gestational hypertensionPregnancy, puerperium and perinatal conditions | 1/217 | 0/215 | 3/211 | 0/208 | 0/202 | 0/207 |
Enrolled women.
| Age, Continuous(years) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| Mean | 27.5 ± 6.2 | 27.0 ± 5.8 | 27.7 ± 5.9 | 27.4 ± 6.0 |
| Sex: Female, Male(Participants) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| Female | 217 | 215 | 211 | 643 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| Hispanic or Latino | 21 | 21 | 18 | 60 |
| Not Hispanic or Latino | 194 | 192 | 190 | 576 |
| Unknown or Not Reported | 2 | 2 | 3 | 7 |
| Race/Ethnicity, Customized(Participants) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| Race — Black or African American | 195 | 196 | 194 | 585 |
| Race — Asian | 7 | 5 | 6 | 18 |
| Race — Other | 10 | 6 | 4 | 20 |
| Race — White | 5 | 7 | 7 | 19 |
| Race — Unknown | 0 | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| United States | 2 | 2 | 0 | 4 |
| Botswana | 16 | 18 | 17 | 51 |
| Tanzania | 15 | 13 | 15 | 43 |
| Brazil | 21 | 19 | 17 | 57 |
| South Africa | 37 | 37 | 37 | 111 |
| Uganda | 37 | 37 | 36 | 110 |
| Zimbabwe | 82 | 84 | 83 | 249 |
| Thailand | 5 | 4 | 6 | 15 |
| India | 2 | 1 | 0 | 3 |
| Gestational Age(weeks) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| Mean | 21.6 ± 4.2 | 21.4 ± 4.2 | 21.8 ± 4.2 | 21.6 ± 4.2 |
| Gestational Age Stratification Group(Participants) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| 14-18 Weeks | 58 | 64 | 59 | 181 |
| 19-23 Weeks | 93 | 83 | 77 | 253 |
| 24-28 Weeks | 66 | 68 | 75 | 209 |
| Plasma HIV-1 RNA Viral Load(copies/mL) | Arm 1: Maternal DTG+FTC/TAF | Arm 2: Maternal DTG+FTC/TDF | Arm 3: Maternal EFV/FTC/TDF | Total |
|---|---|---|---|---|
| Mean | 14,558.2 ± 45,813.9 | 18,420.3 ± 97,896.4 | 13,381.2 ± 42,042.5 | 15,471.2 ± 67,050.5 |
2 further baseline measures are reported on the registry.
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/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Data sharing details ↗ · www.impaactnetwork.org
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Studies of the drug tested here: Dolutegravir
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