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

PHASE3CompletedINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

January 19, 2018

Primary Completion Date

October 3, 2020

Study Completion Date

October 3, 2020

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

Trial Locations (21)

1862

Soweto IMPAACT CRS, Johannesburg

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

4001

Umlazi CRS, Durban

7505

Famcru Crs, Tygerberg

10700

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok

26030

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33136

Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami

50100

Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

411001

Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune

Unknown

Gaborone CRS, Gaborone

Molepolole CRS, Gaborone

Kilimanjaro Christian Medical Centre (KCMC), Moshi

Baylor-Uganda CRS, Kampala

Seke North CRS, Chitungwiza

St Mary's CRS, Chitungwiza

Harare Family Care CRS, Harare

30.130-100

SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte

20221-903

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

21941-612

Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS, Rio de Janeiro

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03048422 - Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants | Biotech Hunter | Biotech Hunter