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Can a new HIV drug combo better protect pregnant women and their babies?

NCT ID NCT03048422

Completed Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This phase 3 trial asks whether a dolutegravir-based HIV regimen works as well as or better than an efavirenz-based regimen in pregnant women living with HIV-1. The study compares how well each treatment suppresses the virus at delivery and checks safety for both mothers and their infants. Around 643 pregnant women are taking part, with outcomes including viral load, pregnancy complications, and serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Dolutegravir (DTG) and efavirenz (EFV) as part of combination antiretroviral therapy
What this could lead to
If successful, this could identify the safest and most effective HIV treatment for pregnant women, reducing mother-to-child transmission and improving outcomes for both.
What could go wrong
The trial is in phase 3 but still may not show clear superiority or non-inferiority. Potential risks include side effects for mothers or infants, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV INFECTIONS

Contacts and locations

Locations

  • Baylor-Uganda CRS

    Kampala, Uganda

  • Byramjee Jeejeebhoy Medical College (BJMC) CRS

    Pune, Maharashtra, 411001, India

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

    Chiang Mai, 50200, Thailand

  • Chiangrai Prachanukroh Hospital NICHD CRS

    Chiang Mai, 50100, Thailand

  • Famcru Crs

    Tygerberg, Western Cape, 7505, South Africa

  • Gaborone CRS

    Gaborone, South-East District, Botswana

  • Harare Family Care CRS

    Harare, Zimbabwe

  • Hosp. Geral De Nova Igaucu Brazil NICHD CRS

    Rio de Janeiro, 26030, Brazil

  • Hospital Federal dos Servidores do Estado NICHD CRS

    Rio de Janeiro, 20221-903, Brazil

  • Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS

    Rio de Janeiro, 21941-612, Brazil

  • Kilimanjaro Christian Medical Centre (KCMC)

    Moshi, Tanzania

  • Molepolole CRS

    Gaborone, Botswana

  • Pediatric Perinatal HIV Clinical Trials Unit CRS

    Miami, Florida, 33136, United States

  • SOM Federal University Minas Gerais Brazil NICHD CRS

    Belo Horizonte, Minas Gerais, 30.130-100, Brazil

  • Seke North CRS

    Chitungwiza, Zimbabwe

  • Siriraj Hospital ,Mahidol University NICHD CRS

    Bangkok, Bangkoknoi, 10700, Thailand

  • Soweto IMPAACT CRS

    Johannesburg, Gauteng, 1862, South Africa

  • St Mary's CRS

    Chitungwiza, Zimbabwe

  • Umlazi CRS

    Durban, KwaZulu-Natal, 4001, South Africa

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209, United States

  • Wits RHI Shandukani Research Centre CRS

    Johannesburg, Gauteng, 2001, South Africa

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