CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 643 enrolled
Drug / intervention
Dolutegravir +3 moredrug
Likely dose
Dolutegravir 50 mg orally once daily + emtricitabine/tenofovir alafenamide (FTC 200 mg/TAF 25 mg) orally once daily OR emtricitabine/tenofovir disoproxil fumarate (FTC 200 mg/TDF 300 mg) orally once daily (experimental arm); compared to efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg) orally once daily (control arm)AI-extracted
Key inclusion· 7
  • ✓Confirmed HIV-1 infection based on two samples at different time points using approved testing methods (rapid antibody tests, EIA, Western blot, HIV DNA/RNA PCR, or nucleic acid test)
  • ✓ART-naive, with permitted exceptions: prior ARVs during prior pregnancies/breastfeeding (concluded ≥6 months prior), up to 14 days ARVs in current pregnancy, or any duration of TDF/FTC-TDF for pre-exposure prophylaxis
  • ✓Gestational age 14-28 weeks at study entry (>13 weeks 6 days, <28 completed weeks)
  • ✓No evidence of multiple gestation or fetal anomalies at screening and study entry
Key exclusion· 12
  • ✕Currently incarcerated or involuntarily confined in a medical facility
  • ✕Currently receiving psychoactive medication for psychiatric illness, treatment for active tuberculosis, or treatment for active hepatitis C
  • ✕Expected to require interferon and/or ribavirin for hepatitis C during study follow-up
  • ✕History of hypersensitivity or clinically significant adverse reaction to any ARVs in the three study regimens

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03048422
NCT03048422Phase 3Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 9, 2017·Updated Nov 21, 2022

In Brief

A Phase 3 clinical trial evaluating Dolutegravir, Emtricitabine/tenofovir alafenamide, and 2 other interventions for HIV Infections. Completed, enrolled 643 participants across 21 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, United States, Zimbabwe
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartJan 19, 2018
Primary CompletionOct 3, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.4 years ago

Interventions

Dolutegravirdrug

One 50 mg DTG tablet was administered orally once daily

Emtricitabine/tenofovir alafenamidedrug

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

Emtricitabine/tenofovir disoproxil fumaratedrug

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

Efavirenz/emtricitabine/tenofovir disoproxil fumaratedrug

One fixed-dose combination tablet (EFV 600 mg/FTC 200 mg/TDF 300 mg) was administered orally once daily