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

NCT03048422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2022-11-21

Study results available
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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.

Conditions

  • HIV Infections

Interventions

DRUG

Dolutegravir

One 50 mg DTG tablet was administered orally once daily

DRUG

Emtricitabine/tenofovir alafenamide

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

DRUG

Emtricitabine/tenofovir disoproxil fumarate

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

DRUG

Efavirenz/emtricitabine/tenofovir disoproxil fumarate

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Shahin Lockman, MD, MSc · Harvard T.H. Chan School of Public Health and Brigham and Women's Hospital

  • Lameck Chinula, MBBS, MMED, FCOG · Kamuzu Central Hospital in Lilongwe, Malawi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2020-10-03
Completion
2020-10-03
FDA Drug
Yes

Countries

  • United States
  • Botswana
  • Brazil
  • India
  • South Africa
  • Tanzania
  • Thailand
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048422 on ClinicalTrials.gov