Can early HIV treatment free infants from lifelong meds?

NCT ID NCT02140255

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

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 6 times

Summary

This study tests whether giving very early and intensive antiretroviral therapy, plus an antibody, can help infants with HIV achieve remission—meaning the virus stays undetectable even after stopping treatment. Researchers will enroll about 1,120 infants and follow them for safety and viral control. The goal is to see if this approach can reduce the need for lifelong daily medication.

What this could mean

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

Active substance: antiretroviral drugs (NRTIs, nevirapine, lopinavir/ritonavir, raltegravir, dolutegravir) and a broadly neutralizing antibody (VRC01)
What this could lead to: If successful, this could point toward a way to achieve HIV remission in infants, potentially reducing the need for lifelong daily medication.
What could go wrong: This is an early phase 1/2 study, so results are uncertain. The treatment is intensive and may cause side effects, and remission may not be achieved or sustained.

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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 INFECTION

Contacts and locations

Locations

12001, Malawi Clinical Research Site
RECRUITING

Lilongwe, Central Region, Malawi
30022, Les Centres GHESKIO Clinical Research Site
RECRUITING

Port-au-Prince, HT-6110, Haiti
30300, Umlazi Clinical Research Site
RECRUITING

Durban, KwaZulu-Natal, 4001, South Africa
30301, Blantyre Clinical Research Site
RECRUITING

Blantyre, Malawi
30303, Saint Mary's Clinical Research Site
RECRUITING

Chitungwiza, Zimbabwe
30306, Seke North Clinical Research Site
RECRUITING

Chitungwiza, Zimbabwe
31798, Baylor-Uganda Clinical Research Site
RECRUITING

Kampala, Uganda
31890, Harare Family Care Clinical Research Site
RECRUITING

Harare, Zimbabwe
32513, IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research Network CRS
WITHDRAWN

San Juan, PR, 00935, Puerto Rico
4001, Lurie Children's Hospital of Chicago Clinical Research Site
RECRUITING

Chicago, Illinois, 60614-3393, United States
4601, University of California, San Diego Clinical Research Site
COMPLETED

La Jolla, California, 92093-0672, United States
5013, Jacobi Medical Center Clinical Research Site
RECRUITING

The Bronx, New York, 10461, United States
5040, SUNY Stony Brook Clinical Research Site
WITHDRAWN

Stony Brook, New York, 11794, United States
5048, University of Southern California Clinical Research Site
RECRUITING

Los Angeles, California, 90089, United States
5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site
RECRUITING

Jacksonville, Florida, 32209, United States
5052, University of Colorado, Denver Clinical Research Site
RECRUITING

Aurora, Colorado, 80045, United States
5055, South Florida CDTC Fort Lauderdale Clinical Research Site
COMPLETED

Fort Lauderdale, Florida, 33316, United States
5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
RECRUITING

Rio de Janeiro, 21941-612, Brazil
5072, Hospital Federal dos Servidores do Estado Clinical Research Site
COMPLETED

Rio de Janeiro, 20221-903, Brazil
5073, School of Medicine Federal University Minas Gerais Clinical Research Site
RECRUITING

Minas Gerais, 30.130-100, Brazil
5074, University of Sao Paulo Clinical Research Site
COMPLETED

São Paulo, 14049-900, Brazil
5083, Rush University Cook County Hospital Clinical Research Site
COMPLETED

Chicago, Illinois, 60612, United States
5092, Johns Hopkins Clinical Research Site
RECRUITING

Baltimore, Maryland, 21287, United States
5097, Hospital Geral de Nova Igaucu Clinical Research Site
COMPLETED

Rio de Janeiro, 26030, Brazil
5112, David Geffen School of Medicine at UCLA Clinical Research Site
RECRUITING

Los Angeles, California, 90095-1752, United States
5114, Bronx Lebanon Hospital Center Clinical Research Site
RECRUITING

The Bronx, New York, 10457, United States
5115, Siriraj Hospital Mahidol University Clinical Research Site
RECRUITING

Bangkok, Bangkoknoi, 10700, Thailand
5116, Chiangrai Prachanukroh Hospital Clinical Research Site
RECRUITING

Chiang Mai, 50100, Thailand
5118, Kilimanjaro Christian Medical Centre Clinical Research Site
RECRUITING

Moshi, Tanzania
5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
RECRUITING

Kericho, 20200, Kenya
5127, Pediatric Perinatal HIV Clinical Research Site
WITHDRAWN

Miami, Florida, 33136, United States
5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site
RECRUITING

Houston, Texas, 77030, United States
6501, St Jude Children's Research Hospital Clinical Research Site
RECRUITING

Memphis, Tennessee, 38105-3678, United States
8950, FAMCRU Clinical Research Site
COMPLETED

Tygerberg, Western Cape, 7505, South Africa
Boston Medical Center Ped. HIV Program NICHD CRS
WITHDRAWN

Boston, Massachusetts, 02118, United States
Emory University School of Medicine NICHD CRS
WITHDRAWN

Atlanta, Georgia, 30322, United States
George CRS
COMPLETED

Lusaka, 10101, Zambia
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS
WITHDRAWN

Buenos Aires, C1221ADC, Argentina
Hospital Nossa Senhora da Conceicao NICHD CRS
COMPLETED

Porto Alegre, Rio Greande Do Sul, 91350-200, Brazil
MU-JHU Care Limited CRS
COMPLETED

Kampala, Uganda
Philadelphia IMPAACT Unit CRS
WITHDRAWN

Philadelphia, Pennsylvania, 9104, United States
San Juan City Hosp. PR NICHD CRS
WITHDRAWN

San Juan, 00936, Puerto Rico
Seattle Children's Research Institute CRS
WITHDRAWN

Seattle, Washington, 98101, United States
Soweto IMPAACT CRS
COMPLETED

Johannesburg, Gauteng, 1862, South Africa
Univ. of Washington NICHD CRS
WITHDRAWN

Seattle, Washington, 98195, United States
Wits RHI Shandukani Research Centre CRS
COMPLETED

Johannesburg, Gauteng, 2001, South Africa

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