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Clinical trialNCT03048422CompletedPhase 3Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment643HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Botswana
  • Gaborone Crs

    Gaborone, South-East District, Botswana

  • Molepolole Crs

    Gaborone, Botswana

Brazil
  • Som Federal University Minas Gerais Brazil Nichd Crs

    Belo Horizonte, Minas Gerais, Brazil

  • Hosp. Geral de Nova Igaucu Brazil Nichd Crs

    Rio de Janeiro, Brazil

  • Hospital Federal Dos Servidores Do Estado Nichd Crs

    Rio de Janeiro, Brazil

  • Instituto de Puericultura E Pediatria Martagao Gesteira - Ufrj Nichd Crs

    Rio de Janeiro, Brazil

India
  • Byramjee Jeejeebhoy Medical College (bjmc) Crs

    Pune, Maharashtra, India

South Africa
  • Soweto Impaact Crs

    Johannesburg, Gauteng, South Africa

  • Wits Rhi Shandukani Research Centre Crs

    Johannesburg, Gauteng, South Africa

  • Umlazi Crs

    Durban, KwaZulu-Natal, South Africa

  • Famcru Crs

    Tygerberg, Western Cape, South Africa

Tanzania
  • Kilimanjaro Christian Medical Centre (kcmc)

    Moshi, Tanzania

Thailand
  • Siriraj Hospital ,mahidol University Nichd Crs

    Bangkok, Bangkoknoi, Thailand

  • Chiang Mai University Hiv Treatment (cmu Hiv Treatment) Crs

    Chiang Mai, Thailand

  • Chiangrai Prachanukroh Hospital Nichd Crs

    Chiang Mai, Thailand

Uganda
  • Baylor-Uganda Crs

    Kampala, Uganda

United States
  • Univ. of Florida Jacksonville Nichd Crs

    Jacksonville, Florida, United States

  • Pediatric Perinatal Hiv Clinical Trials Unit Crs

    Miami, Florida, United States

Zimbabwe
  • Seke North Crs

    Chitungwiza, Zimbabwe

  • St Mary'S Crs

    Chitungwiza, Zimbabwe

  • Harare Family Care Crs

    Harare, Zimbabwe

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Dolutegravir →Efavirenz →Emtricitabine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Jan 2018
Primary completion
3 Oct 2020
Completion
3 Oct 2020
Last update posted
31 Jul 2026
Registered enrollment
643
Registry id
NCT03048422
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.