NCT03048422

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 643 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-19
• Primary completion: 2020-10-03
• Completion: 2020-10-03
• First posted: 2017-02-09
• Last updated: 2022-11-21
• Results posted: 2021-11-10

Locations

21 sites across 9 countries: United States, Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, Zimbabwe

Regulatory

• FDA-regulated drug study