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CompletedNCT03048422VESTEDUpdated Jul 31, 2026Results posted

Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

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

Phase
Phase 3
Study type
Interventional
Enrollment
643
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • HIV Infections

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Mother is able to provide written informed consent for her and her infant's participation in this study

  • Mother has confirmed HIV-1 infection based on documented testing of two samples collected at different time points:

    • Sample #1 may be tested using any of the following:
    • Two rapid antibody tests from different manufacturers or based on different principles and epitopes
    • One enzyme immunoassay (EIA) OR Western blot OR immunofluorescence assay OR chemiluminescence assay
    • One HIV DNA polymerase chain reaction (PCR)
    • One quantitative HIV RNA PCR (above the limit of detection of the assay)
    • One qualitative HIV RNA PCR
    • One total HIV nucleic acid test
    • Sample #2 may be tested using any of the following:
    • One rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be FDA-approved and the third rapid test must be from a third manufacturer or based on a third principle or epitope.
    • One EIA OR Western blot OR immunofluorescence assay OR chemiluminescence assay
    • One HIV DNA PCR
    • One quantitative HIV RNA PCR (above the limit of detection of the assay)
    • One qualitative HIV RNA PCR
    • One total HIV nucleic acid test.
    • See the protocol for more information on this inclusion criterion.
  • At screening, mother is ART-naive, defined as having not received prior antiretroviral therapy other than ARVs received during prior pregnancies or prior periods of breastfeeding (i.e., receipt of any single, dual, or triple ARV regimen during prior time-limited periods of pregnancy and breastfeeding is permitted). Receipt of up to 14 days of ARVs during the current pregnancy is permitted prior to study entry so that initiation of ARVs during the current pregnancy is not delayed during the study screening period. Note: Non-study ART may be initiated in the current pregnancy prior to initiation of the study screening process. For eligible participants, enrollment must occur within 14 days of non-study ART initiation. Note: Receipt of ARVs during a prior pregnancy or prior period of breastfeeding must have concluded at least six months prior to study entry. Receipt of TDF or FTC/TDF for pre-exposure prophylaxis at any time in the past is not exclusionary (even if received within six months prior to study entry).

  • At screening, mother has the following laboratory test results (based on testing of samples collected within 14 days prior to study entry):

    • Grade 1 or lower (less than 2.5 times upper limit of normal [ULN]) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
    • Grade 2 or lower (less than or equal to 1.8 times ULN) creatinine
    • Grade 2 or lower (greater than or equal to 60 mL/min) estimated creatinine clearance (CrCl; Cockcroft-Gault formula). See the protocol for guidance on severity grading. Laboratory tests may be repeated during the study screening period, with the latest result used for eligibility determination.
  • At screening and at study entry, no evidence of multiple gestation or fetal anomalies, as assessed by best available method
  • At study entry, gestational age of 14-28 weeks, defined as greater than 13 weeks plus six days and less than 28 completed weeks gestation, estimated by best available method. Note: For this inclusion criterion and the previous inclusion criterion, fetal ultrasound is preferred but not required for purposes of eligibility determination. If ultrasound cannot be performed during the study screening period prior to study entry, it must be performed within 14 days after study entry. As further explained in the protocol, enrolled participants will not be withdrawn from the study based on ultrasound findings obtained after study entry.
  • At study entry, mother expects to remain in the geographic area of the study site during pregnancy and for 50 weeks postpartum [Eligibility criteria added per Letter of Amendment 1 to V2; July 2018]:

  • 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 contraception during this period. Effective contraception may include surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) or any of the following methods:

    • Contraceptive intrauterine device (IUD) or intrauterine system (IUS)
    • Subdermal contraceptive implant
    • Progestogen injections
    • Progestogen only oral contraceptive pills
    • Combined estrogen and progestogen oral contraceptive pills
    • Percutaneous contraceptive patches
    • Contraceptive vaginal rings
    • Note: IUDs, IUSs, implants, and injections are strongly recommended due to their lower failure rates with typical use. Male or female condom use is recommended with all contraceptive methods for dual protection against pregnancy and to avoid transmission of HIV and other sexually transmitted infections.

Exclusion criteria

Exclusion Criteria:

  • Mother is currently incarcerated or involuntarily confined in a medical facility

  • Mother is currently receiving:

    • A psychoactive medication for treatment of a psychiatric illness
    • Treatment for active tuberculosis
    • Treatment for active hepatitis C infection
  • Mother is expected to require treatment with interferon and/or ribavirin for hepatitis C infection during the study follow-up period

  • 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:

    • Hypersensitivity or clinically significant adverse reaction to any of the ARVs included in the three study drug regimens (ever)
    • Antiretroviral drug resistance mutations that would impact selection of ART regimen (ever)
    • Clinically significant heart disease and/or known prolonged corrected QT (QTc) interval (ever)
    • Suicidal ideation or attempt (ever)
    • HIV-2 infection (ever)
    • Zika virus infection, diagnosed or suspected, during the current pregnancy
    • Receipt of any antiretroviral medication within six months prior to study entry, with two exceptions: receipt of any duration of TDF or FTC/TDF for pre-exposure prophylaxis or receipt of up to 14 days of ARVs during the current pregnancy
    • Receipt of any prohibited medication within 14 days prior to study entry (see the protocol for more information)
    • Clinically significant acute illness requiring systemic treatment and/or hospitalization (i.e., major medical condition that is likely to lead to hospitalization and/or to an adverse pregnancy outcome) within 14 days prior to study entry
    • Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) within 14 days prior to study entry
    • Note: Testing to rule out HIV-2 infection is not required.
  • Mother or fetus has any other condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
643 participants (actual)

Study arms

  • Experimental
    Arm 1: Maternal DTG+FTC/TAF

    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

  • Experimental
    Arm 2: Maternal DTG+FTC/TDF

    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

  • Active comparator
    Arm 3: Maternal EFV/FTC/TDF

    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

  • No intervention
    Arm 1 Infants

    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.

  • No intervention
    Arm 2 Infants

    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.

  • No intervention
    Arm 3 Infants

    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.

Interventions

  • DrugDolutegravir

    One 50 mg DTG tablet was administered orally once daily

    Also known as: DTG

  • DrugEmtricitabine/tenofovir alafenamide

    One fixed-dose combination tablet (FTC 200 mg/TAF 25 mg) was administered orally once daily

    Also known as: FTC/TAF

  • DrugEmtricitabine/tenofovir disoproxil fumarate

    One fixed-dose combination tablet (FTC 200 mg/TDF 300 mg) was administered orally once daily

    Also known as: FTC/TDF

  • DrugEfavirenz/emtricitabine/tenofovir disoproxil fumarate

    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

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Maternal Change in Creatinine Clearance

    Maternal change in creatinine clearance per week based on generalized estimating equations

    Time frame: Baseline to 50 weeks postpartum

  14. Infant Creatinine Clearance

    Infant creatinine clearance based on Schwartz formula

    Time frame: Delivery and 26 weeks postpartum

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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)

  20. Change in Maternal Weight Postpartum

    Change in maternal postpartum weight per week based on generalized estimating equations

    Time frame: Delivery to 50 weeks postpartum

  21. Change in Maternal Weight Overall

    Change in maternal weight per week based on generalized estimating equations

    Time frame: Baseline to 50 weeks postpartum

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

06

Results

Posted Nov 10, 2021

Participant flow

Participant flow — Overall Study
MilestoneArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Started217215211
Completed200205202
Not completed17109
Withdrew: Death100
Withdrew: Lost to follow-up501
Withdrew: Withdrawal by subject574
Withdrew: Moved322
Withdrew: Noncompliant with study requirements212
Withdrew: Not able to get to clinic100

Outcome measures

PrimaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
Percentage of participantsArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Intention-to-Treat Analysis97.591.0
Per-Protocol Analysis97.591.4
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Risk difference (rd): 6.5 · 95% CI 2.0 to 10.7
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Risk difference (rd): 6.0 · 95% CI 1.6 to 10.3
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.005 · Risk difference (rd): 6.5 · 95% CI 2.0 to 10.7
PrimaryPercentage 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
Reported as:
Number · percentage of mother-infant pairs
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
percentage of mother-infant pairsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome24.132.932.7
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.043 · Risk difference (rd): -8.8 · 95% CI -17.3 to -0.3
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.97 · Risk difference (rd): 0.2 · 95% CI -8.8 to 9.1
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.047 · Risk difference (rd): -8.6 · 95% CI -17.1 to -0.1
PrimaryCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
Cumulative probability per 100 personsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event25.130.827.9
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Z-test · p = 0.098 · Risk difference (rd): -5.6 · 95% CI -14.2 to 2.9
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.26 · Risk difference (rd): 2.6 · 95% CI -5.9 to 11.7
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.26 · Risk difference (rd): -2.8 · 95% CI -11.3 to 5.8
PrimaryCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
Cumulative probability per 100 personsArm 1 InfantsArm 2 InfantsArm 3 Infants
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event25.328.630.9
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · Z-test · p = 0.25 · Risk difference (rd): -3.2 · 95% CI -12.8 to 6.3
  • Arm 2 Infants vs Arm 3 Infants · Z-test · p = 0.32 · Risk difference (rd): -2.3 · 95% CI -12.1 to 7.5
  • Arm 1 Infants vs Arm 3 Infants · Z-test · p = 0.11 · Risk difference (rd): -5.5 · 95% CI -14.3 to 3.2
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
percentage of participantsArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory94.478.8
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = < 0.0001 · Risk difference (rd): 15.6 · 95% CI 9.3 to 22.0
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum
percentage of participantsArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum96.396.4
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.97 · Risk difference (rd): -0.1 · 95% CI -3.3 to 3.2
SecondaryTime 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
Reported as:
Mean · weeks
Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
weeksArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery4.26 ± 0.096.49 ± 0.31
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Kaplan-Meier · p = < 0.001 · Hazard ratio (hr): 2.4 · 95% CI 1.9 to 3.1
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm
percentage of participantsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 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 Algorithm88.992.681.0
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.19 · Risk difference (rd): 3.6 · 95% CI -1.8 to 9.1
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = < 0.001 · Risk difference (rd): -11.5 · 95% CI -17.9 to -5.2
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.022 · Risk difference (rd): -7.9 · 95% CI -14.6 to -1.2
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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 participantsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 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 Algorithm75.677.776.3
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.61 · Risk difference (rd): 2.1 · 95% CI -5.9 to 10.1
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.74 · Risk difference (rd): -1.4 · 95% CI -9.4 to 6.6
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.86 · Risk difference (rd): 0.7 · 95% CI -7.4 to 8.8
SecondaryPercentage 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
Reported as:
Number · percentage of mother-infant pairs
Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome
percentage of mother-infant pairsArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome28.432.7
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.27 · Risk difference (rd): 4.3 · 95% CI -3.4 to 11.9
SecondaryCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
Cumulative probability per 100 personsArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event27.927.9
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.49 · Risk difference (rd): -0.1 · 95% CI -7.6 to 7.5
SecondaryCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
Cumulative probability per 100 personsArms 1 and 2 InfantsArm 3 Infants
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event26.830.9
Statistical analysis
  • Arms 1 and 2 Infants vs Arm 3 Infants · Z-test · p = 0.15 · Risk difference (rd): 4.1 · 95% CI -3.8 to 12.0
SecondaryPercentage 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
Reported as:
Number · percentage of mother-infant pairs
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly
percentage of mother-infant pairsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly24.132.933.2
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.043 · Risk difference (rd): -8.8 · 95% CI -17.3 to -0.3
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.95 · Risk difference (rd): -0.3 · 95% CI -9.3 to 8.6
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.037 · Risk difference (rd): -9.1 · 95% CI -17.6 to -0.6
SecondaryCount 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
Reported as:
Count of participants · Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome
ParticipantsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Infant Death2414
Spontaneous abortion or stillbirth8114
HIV-1 Infection201
Extremely and Very Preterm Delivery112
Major Congenital Anomaly201
Preterm Delivery101718
Small for Gestational Age293836
Infant Hospitalization181419
Infant Grade 3 or 4 Adverse Event786
None137120110
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Regression, Ordinal · p = 0.095 · Odds ratio (or): 0.73 · 95% CI 0.50 to 1.06
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Regression, Ordinal · p = 0.30 · Odds ratio (or): 0.83 · 95% CI 0.58 to 1.19
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Regression, Ordinal · p = 0.008 · Odds ratio (or): 0.60 · 95% CI 0.42 to 0.88
SecondaryCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Infant HIV-infection
Cumulative probability per 100 personsArm 1 InfantsArm 2 InfantsArm 3 Infants
Cumulative Probability of Infant HIV-infection0.980.500.55
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · Z-test · p = 0.28 · Risk difference (rd): 0.5 · 95% CI -1.2 to 2.1
  • Arm 2 Infants vs Arm 3 Infants · Z-test · p = 0.47 · Risk difference (rd): -0.1 · 95% CI -1.5 to 1.4
  • Arm 1 Infants vs Arm 3 Infants · Z-test · p = 0.31 · Risk difference (rd): 0.4 · 95% CI -1.3 to 2.2
SecondaryCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Infant Deaths
Cumulative probability per 100 personsArm 1 InfantsArm 2 InfantsArm 3 Infants
Cumulative Probability of Infant Deaths1.02.06.9
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · Z-test · p = 0.20 · Risk difference (rd): -1.0 · 95% CI -3.4 to 1.3
  • Arm 2 Infants vs Arm 3 Infants · Z-test · p = 0.008 · Risk difference (rd): -4.9 · 95% CI -8.9 to -0.9
  • Arm 1 Infants vs Arm 3 Infants · Z-test · p = <0.001 · Risk difference (rd): -5.9 · 95% CI -9.7 to -2.2
SecondaryMaternal Change in Creatinine Clearance

Maternal change in creatinine clearance per week based on generalized estimating equations

Time frame:
Baseline to 50 weeks postpartum
Reported as:
Mean · mL/min
Maternal Change in Creatinine Clearance
mL/minArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 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)
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Generalized Estimating Equation · p = 0.12 · Mean difference (final values): -0.093 · 95% CI -0.208 to 0.023
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = 0.39 · Mean difference (final values): 0.048 · 95% CI -0.061 to 0.158
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = 0.45 · Mean difference (final values): -0.045 · 95% CI -0.161 to 0.072
SecondaryInfant Creatinine Clearance

Infant creatinine clearance based on Schwartz formula

Time frame:
Delivery and 26 weeks postpartum
Reported as:
Mean · mL/min
Infant Creatinine Clearance
mL/minArm 1 InfantsArm 2 InfantsArm 3 Infants
Delivery52.7 ± 29.653.1 ± 69.749.0 ± 24.7
26 Weeks Postpartum134.8 ± 109.6123.6 ± 40.3135.0 ± 51.1
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · t-test, 2 sided · p = 0.94 · Mean difference (final values): -0.4 · 95% CI -11.3 to 10.5
  • Arm 2 Infants vs Arm 3 Infants · t-test, 2 sided · p = 0.44 · Mean difference (final values): 4.2 · 95% CI -6.5 to 14.9
  • Arm 1 Infants vs Arm 3 Infants · t-test, 2 sided · p = 0.18 · Mean difference (final values): 3.8 · 95% CI -1.8 to 9.3
  • Arm 1 Infants vs Arm 2 Infants · t-test, 2 sided · p = 0.27 · Mean difference (final values): 11.1 · 95% CI -8.9 to 31.1
  • Arm 2 Infants vs Arm 3 Infants · t-test, 2 sided · p = 0.048 · Mean difference (final values): -11.4 · 95% CI -22.6 to -0.1
  • Arm 1 Infants vs Arm 3 Infants · t-test, 2 sided · p = 0.98 · Mean difference (final values): -0.2 · 95% CI -21.0 to 20.5
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
percentage of participantsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure0.921.866.16
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.40 · Risk difference (rd): -0.9 · 95% CI -3.1 to 1.3
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.023 · Risk difference (rd): -4.3 · 95% CI -8.0 to -0.6
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.003 · Risk difference (rd): -5.2 · 95% CI -8.7 to -1.8
SecondaryCount 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
Reported as:
Count of participants · Participants
Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis
ParticipantsArm 1 InfantsArm 2 InfantsArm 3 Infants
Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis101
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Mother-Infant Pairs With Preterm Deliveries
percentage of participantsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Percentage of Mother-Infant Pairs With Preterm Deliveries5.89.412.1
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.16 · Risk difference (rd): -3.6 · 95% CI -8.8 to 1.5
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.38 · Risk difference (rd): -2.7 · 95% CI -8.7 to 3.3
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.023 · Risk difference (rd): -6.3 · 95% CI -11.8 to -0.9
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Infants Born Small for Gestational Age
percentage of participantsArm 1 InfantsArm 2 InfantsArm 3 Infants
Percentage of Infants Born Small for Gestational Age16.322.520.5
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · Wald test of two proportions · p = 0.12 · Risk difference (rd): -6.2 · 95% CI -13.9 to 1.5
  • Arm 2 Infants vs Arm 3 Infants · Wald test of two proportions · p = 0.63 · Risk difference (rd): 2.0 · 95% CI -6.0 to 10.0
  • Arm 1 Infants vs Arm 3 Infants · Wald test of two proportions · p = 0.28 · Risk difference (rd): -4.2 · 95% CI -11.7 to 3.4
SecondaryChange 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)
Reported as:
Mean · kg/week
Change in Maternal Weight Antepartum
kg/weekArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Change in Maternal Weight Antepartum0.378 (0.343 to 0.412)0.319 (0.291 to 0.348)0.291 (0.260 to 0.322)
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Generalized Estimating Equation · p = 0.011 · Mean difference (final values): 0.058 · 95% CI 0.013 to 0.103
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = 0.19 · Mean difference (final values): 0.028 · 95% CI -0.014 to 0.070
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = < 0.001 · Mean difference (final values): 0.086 · 95% CI 0.040 to 0.133
SecondaryChange in Maternal Weight Postpartum

Change in maternal postpartum weight per week based on generalized estimating equations

Time frame:
Delivery to 50 weeks postpartum
Reported as:
Mean · kg/week
Change in Maternal Weight Postpartum
kg/weekArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Change in Maternal Weight Postpartum0.014 (-0.004 to 0.032)-0.008 (-0.027 to 0.012)-0.032 (-0.048 to -0.017)
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Generalized Estimating Equation · p = 0.11 · Mean difference (final values): 0.022 · 95% CI -0.005 to 0.048
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = 0.055 · Mean difference (final values): 0.024 · 95% CI -0.000 to 0.049
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = < 0.001 · Mean difference (final values): 0.046 · 95% CI 0.022 to 0.070
SecondaryChange in Maternal Weight Overall

Change in maternal weight per week based on generalized estimating equations

Time frame:
Baseline to 50 weeks postpartum
Reported as:
Mean · kg/week
Change in Maternal Weight Overall
kg/weekArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 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)
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Generalized Estimating Equation · p = 0.041 · Mean difference (final values): 0.023 · 95% CI 0.001 to 0.045
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = 0.002 · Mean difference (final values): 0.034 · 95% CI 0.013 to 0.055
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Generalized Estimating Equation · p = < 0.001 · Mean difference (final values): 0.057 · 95% CI 0.036 to 0.078
Other pre-specifiedPercentage 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
Reported as:
Number · Percentage
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery by Race
PercentageArms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Black or African American97.390.7
Asian100.0100.0
White100.0100.0
Other100.075.0
Statistical analysis
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Risk difference (rd): 6.5 · 95% CI 2.0 to 11.1
  • Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Risk difference (rd): 25.0 · 95% CI -17.4 to 67.4
Other pre-specifiedPercentage 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
Reported as:
Number · Percentage
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome by Maternal Race
PercentageArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Black or African American25.333.530.9
Asian42.940.050.0
White0.042.942.9
Other0.00.075.0
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.073 · Risk difference (rd): -8.2 · 95% CI -17.3 to 0.8
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.59 · Risk difference (rd): 2.6 · 95% CI -6.7 to 11.9
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.21 · Risk difference (rd): -5.7 · 95% CI -14.6 to 3.3
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Wald test of two proportions · p = 0.92 · Risk difference (rd): 2.9 · 95% CI -53.6 to 59.3
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.74 · Risk difference (rd): -10.0 · 95% CI -68.7 to 48.7
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Wald test of two proportions · p = 0.80 · Risk difference (rd): -7.1 · 95% CI -61.4 to 47.1
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Fisher's Mid-P Test · p = 0.13
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Fisher's Mid-P Test · p = 0.80
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Fisher's Mid-P Test · p = 0.13
Other pre-specifiedCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event by Race
Cumulative probability per 100 personsArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDF
Black or African American26.430.226.2
AsianNA20.016.7
White20.028.657.1
Other10.050.075.0
Statistical analysis
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Z-test · p = 0.21 · Risk difference (rd): -3.7 · 95% CI -12.8 to 5.3
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.20 · Risk difference (rd): 4.0 · 95% CI -5.1 to 13.1
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.48 · Risk difference (rd): 0.3 · 95% CI -8.7 to 9.2
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Z-test · p = 0.36 · Risk difference (rd): -8.6 · 95% CI -57.0 to 39.9
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.13 · Risk difference (rd): -28.6 · 95% CI -78.2 to 21.1
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.076 · Risk difference (rd): -37.1 · 95% CI -87.9 to 13.6
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 2: Maternal DTG+FTC/TDF · Z-test · p = 0.038 · Risk difference (rd): -40.0 · 95% CI -84.1 to 4.1
  • Arm 2: Maternal DTG+FTC/TDF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.20 · Risk difference (rd): -25.0 · 95% CI -83.3 to 33.3
  • Arm 1: Maternal DTG+FTC/TAF vs Arm 3: Maternal EFV/FTC/TDF · Z-test · p = 0.003 · Risk difference (rd): -65.0 · 95% CI -111.3 to -18.7
Other pre-specifiedCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event by Race
Cumulative probability per 100 personsArm 1 InfantsArm 2 InfantsArm 3 Infants
Black or African American23.428.330.8
AsianNA40.0NA
White20.0NA42.9
Other60.0NANA
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · Z-test · p = 0.17 · Risk difference (rd): -4.9 · 95% CI -15.1 to 5.3
  • Arm 2 Infants vs Arm 3 Infants · Z-test · p = 0.32 · Risk difference (rd): -2.5 · 95% CI -13.0 to 7.9
  • Arm 1 Infants vs Arm 3 Infants · Z-test · p = 0.054 · Risk difference (rd): -7.4 · 95% CI -16.5 to 1.6
Other pre-specifiedCumulative 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
Reported as:
Number · Cumulative probability per 100 persons
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event by Sex
Cumulative probability per 100 personsArm 1 InfantsArm 2 InfantsArm 3 Infants
Female17.824.834.1
Male32.333.127.2
Statistical analysis
  • Arm 1 Infants vs Arm 2 Infants · Z-test · p = 0.15 · Risk difference (rd): -7.0 · 95% CI -20.5 to 6.4
  • Arm 2 Infants vs Arm 3 Infants · Z-test · p = 0.10 · Risk difference (rd): -9.3 · 95% CI -23.7 to 5.2
  • Arm 1 Infants vs Arm 3 Infants · Z-test · p = 0.004 · Risk difference (rd): -16.3 · 95% CI -28.4 to -4.2
  • Arm 1 Infants vs Arm 2 Infants · Z-test · p = 0.45 · Risk difference (rd): -0.8 · 95% CI -14.0 to 12.4
  • Arm 2 Infants vs Arm 3 Infants · Z-test · p = 0.19 · Risk difference (rd): 5.9 · 95% CI -7.1 to 18.9
  • Arm 1 Infants vs Arm 3 Infants · Z-test · p = 0.21 · Risk difference (rd): 5.1 · 95% CI -7.3 to 17.5

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: Maternal DTG+FTC/TAF1/217 (0.5%)39/217 (18%)189/217 (87.1%)
Arm 2: Maternal DTG+FTC/TDF0/215 (0%)39/215 (18.1%)198/215 (92.1%)
Arm 3: Maternal EFV/FTC/TDF0/211 (0%)40/211 (19%)143/211 (67.8%)
Arm 1 Infants2/208 (1%)35/208 (16.8%)34/208 (16.3%)
Arm 2 Infants4/202 (2%)29/202 (14.4%)40/202 (19.8%)
Arm 3 Infants14/207 (6.8%)44/207 (21.3%)34/207 (16.4%)
Most frequent serious events
Showing 10 of 154
Most frequent serious events
EventArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFArm 1 InfantsArm 2 InfantsArm 3 Infants
Sepsis neonatalInfections and infestations0/2170/2150/2114/2087/2026/207
Gestational hypertensionPregnancy, puerperium and perinatal conditions4/2175/2157/2110/2080/2020/207
Foetal deathPregnancy, puerperium and perinatal conditions6/2177/2151/2110/2080/2020/207
Premature babyPregnancy, puerperium and perinatal conditions0/2170/2150/2111/2085/2024/207
PneumoniaInfections and infestations0/2170/2151/2114/2082/2025/207
Hypoxic-ischaemic encephalopathyNervous system disorders0/2170/2150/2112/2080/2025/207
Meconium aspiration syndromeRespiratory, thoracic and mediastinal disorders0/2170/2150/2112/2081/2025/207
Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders0/2170/2150/2115/2082/2022/207
Foetal distress syndromePregnancy, puerperium and perinatal conditions2/2172/2155/2110/2080/2020/207
Preterm premature rupture of membranesPregnancy, puerperium and perinatal conditions2/2173/2154/2110/2080/2020/207
Most frequent other events
Showing 10 of 124
Most frequent other events
EventArm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFArm 1 InfantsArm 2 InfantsArm 3 Infants
Creatinine renal clearance decreasedInvestigations182/217193/215132/2110/2080/2020/207
Blood creatinine increasedInvestigations170/217179/21576/2114/2088/2024/207
Haemoglobin decreasedInvestigations8/21720/21514/2118/2088/2027/207
Neutrophil count decreasedInvestigations0/2170/2152/21110/2087/20214/207
Alanine aminotransferase increasedInvestigations5/2176/2154/2110/2080/2020/207
Blood glucose decreasedInvestigations0/2170/2150/2113/2082/2024/207
Aspartate aminotransferase increasedInvestigations3/2174/2154/2110/2080/2020/207
Platelet count decreasedInvestigations1/2170/2151/2110/2083/2020/207
AnaemiaBlood and lymphatic system disorders0/2171/2153/2110/2080/2021/207
Gestational hypertensionPregnancy, puerperium and perinatal conditions1/2170/2153/2110/2080/2020/207

Baseline characteristics

Enrolled women.

Age, Continuous
Age, Continuous(years)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
Mean27.5 ± 6.227.0 ± 5.827.7 ± 5.927.4 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
Female217215211643
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
Hispanic or Latino21211860
Not Hispanic or Latino194192190576
Unknown or Not Reported2237
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
Race — Black or African American195196194585
Race — Asian75618
Race — Other106420
Race — White57719
Race — Unknown0101
Region of Enrollment
Region of Enrollment(Participants)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
United States2204
Botswana16181751
Tanzania15131543
Brazil21191757
South Africa373737111
Uganda373736110
Zimbabwe828483249
Thailand54615
India2103
Gestational Age
Gestational Age(weeks)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
Mean21.6 ± 4.221.4 ± 4.221.8 ± 4.221.6 ± 4.2
Gestational Age Stratification Group
Gestational Age Stratification Group(Participants)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
14-18 Weeks586459181
19-23 Weeks938377253
24-28 Weeks666875209
Plasma HIV-1 RNA Viral Load
Plasma HIV-1 RNA Viral Load(copies/mL)Arm 1: Maternal DTG+FTC/TAFArm 2: Maternal DTG+FTC/TDFArm 3: Maternal EFV/FTC/TDFTotal
Mean14,558.2 ± 45,813.918,420.3 ± 97,896.413,381.2 ± 42,042.515,471.2 ± 67,050.5

2 further baseline measures are reported on the registry.

07

Study locations

21 sites
  • Univ. of Florida Jacksonville NICHD CRS
    Jacksonville, Florida 32209, United States
  • Pediatric Perinatal HIV Clinical Trials Unit CRS
    Miami, Florida 33136, United States
  • Gaborone CRS
    Gaborone, South-East District, Botswana
  • Molepolole CRS
    Gaborone, Botswana
  • SOM Federal University Minas Gerais Brazil NICHD CRS
    Belo Horizonte, Minas Gerais 30.130-100, Brazil
  • Hospital Federal dos Servidores do Estado NICHD CRS
    Rio de Janeiro, 20221-903, Brazil
  • Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS
    Rio de Janeiro, 21941-612, Brazil
  • Hosp. Geral De Nova Igaucu Brazil NICHD CRS
    Rio de Janeiro, 26030, Brazil
  • Byramjee Jeejeebhoy Medical College (BJMC) CRS
    Pune, Maharashtra 411001, India
  • Soweto IMPAACT CRS
    Johannesburg, Gauteng 1862, South Africa
  • Wits RHI Shandukani Research Centre CRS
    Johannesburg, Gauteng 2001, South Africa
  • Umlazi CRS
    Durban, KwaZulu-Natal 4001, South Africa
  • Famcru Crs
    Tygerberg, Western Cape 7505, South Africa
  • Kilimanjaro Christian Medical Centre (KCMC)
    Moshi, Tanzania
  • Siriraj Hospital ,Mahidol University NICHD CRS
    Bangkok, Bangkoknoi 10700, Thailand
  • Chiangrai Prachanukroh Hospital NICHD CRS
    Chiang Mai, 50100, Thailand
  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
    Chiang Mai, 50200, Thailand
  • Baylor-Uganda CRS
    Kampala, Uganda
  • Seke North CRS
    Chitungwiza, Zimbabwe
  • St Mary's CRS
    Chitungwiza, Zimbabwe
  • Harare Family Care CRS
    Harare, Zimbabwe
08

References and documents

Publications

  • Lockman S, Brummel SS, Ziemba L, Stranix-Chibanda L, McCarthy K, Coletti A, Jean-Philippe P, Johnston B, Krotje C, Fairlie L, Hoffman RM, Sax PE, Moyo S, Chakhtoura N, Stringer JS, Masheto G, Korutaro V, Cassim H, Mmbaga BT, Joao E, Hanley S, Purdue L, Holmes LB, Momper JD, Shapiro RL, Thoofer NK, Rooney JF, Frenkel LM, Amico KR, Chinula L, Currier J; IMPAACT 2010/VESTED Study Team and Investigators. Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2021 Apr 3;397(10281):1276-1292. doi: 10.1016/S0140-6736(21)00314-7. PubMed 33812487 ↗
  • Masheto G, Brummel SS, Ziemba L, Shepherd J, Mbengeranwa T, Igawa L, Coletti A, Mukura D, Rossouw L, Theron G, Krotje C, Jean-Philippe P, Chakhtoura N, Cassim H, Mathiba SR, Maena J, Murtaugh W, Fairlie L, Currier J, Hoffman R, Chinula L, Sax PE, Stranix-Chibanda L, Lockman S; IMPAACT 2010/VESTED Study Team and Investigators. Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):172-179. doi: 10.1097/QAI.0000000000003478. PubMed 39250651 ↗
  • Eke AC, Brummel SS, Aliyu MH, Stranix-Chibanda L, Eleje GU, Ezebialu IU, Korutaro V, Wabwire D, Matubu A, Mbengeranwa T, Chakhtoura N, Chinula L, McCarthy K, Knowles K, Krotje C, Linton MF, Dooley KE, Sax PE, Brown T, Lockman S; IMPAACT 2010/VESTED Study Team. Lipid and Glucose Profiles in Pregnant Women With HIV on Tenofovir-based Antiretroviral Therapy. Clin Infect Dis. 2025 Mar 17;80(3):594-601. doi: 10.1093/cid/ciae441. PubMed 39219495 ↗
  • Jacobson DL, Crider KS, DeMarrais P, Brummel S, Zhang M, Pfeiffer CM, Moore CA, McCarthy K, Johnston B, Mohammed T, Vhembo T, Kabugho E, Muzorah GA, Cassim H, Fairlie L, Machado ES, Ngocho JS, Shapiro RL, Serghides L, Chakhtoura N, Chinula L, Lockman S. Dolutegravir- Versus Efavirenz-Based Treatment in Pregnancy: Impact on Red Blood Cell Folate Concentrations in Pregnant Women and Their Infants. J Infect Dis. 2024 Nov 15;230(5):1224-1234. doi: 10.1093/infdis/jiae308. PubMed 38877762 ↗
  • Chinula L, Ziemba L, Brummel S, McCarthy K, Coletti A, Krotje C, Johnston B, Knowles K, Moyo S, Stranix-Chibanda L, Hoffman R, Sax PE, Stringer J, Chakhtoura N, Jean-Philippe P, Korutaro V, Cassim H, Fairlie L, Masheto G, Boyce C, Frenkel LM, Amico KR, Purdue L, Shapiro R, Mmbaga BT, Patel F, van Wyk J, Rooney JF, Currier JS, Lockman S; IMPAACT 2010/VESTED Study Team and Investigators. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet HIV. 2023 Jun;10(6):e363-e374. doi: 10.1016/S2352-3018(23)00061-9. Epub 2023 May 8. PubMed 37167996 ↗

Study documents

  • Protocol and informed consent form · Dec 8, 2017
  • Study protocol · Jul 20, 2018
  • Study protocol · Aug 23, 2019
  • Study protocol · Jun 10, 2020
  • Statistical analysis plan · Oct 26, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification

Supporting information: Study protocol, Sap

09

Registry details

Key details

Study ID
NCT03048422
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Feb 9, 2017
Start date
Jan 19, 2018
Primary completion
Oct 3, 2020
Completion
Oct 3, 2020
Results posted
Nov 10, 2021
Last update
Jul 31, 2026

Study contacts

Shahin Lockman, MD, MSc
study chair · Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital
Lameck Chinula, MBBS, MMED, FCOG
study chair · Kamuzu Central Hospital in Lilongwe, Malawi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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