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Can early HIV treatment free infants from lifelong meds?

NCT ID NCT02140255

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 10 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.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 1,120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2015

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 48 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Maternal Inclusion Criteria 1. Presumed or confirmed maternal HIV infection: * Mothers will be eligible to enroll with EITHER: * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR * Confirmed HIV infection defined as positive results from two samples collected at different timepoints 2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB/EC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent. 3. Was not previously enrolled in this study with another infant. 4. Did not receive ARVs during the current pregnancy. 5. Infant is eligible per inclusion criteria. Infant Inclusion Criteria for Step 1 1. Less than or equal to 48 hours of age. 2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score). 3. Greater than or equal to 2 kilograms (kg) at birth. 4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube. 5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation. 6. Mother is eligible per inclusion criteria. Infant Inclusion Criteria for Step 2 1. Enrolled in Step 1. 2. Confirmed in utero HIV infection. 3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube. 4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation. 5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2. Infant Inclusion Criteria for Step 3 1. Enrolled in Step 2. 2. Has reached Step 2 Week 96. 3. Has the following results based on testing: * No confirmed plasma HIV RNA ≥200 copies/mL at Step 2 Week 24 and up to but excluding Step 2 Week 48. * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \<200 copies/mL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test). * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \<200 copies/mL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2. * If HIV RNA is detected on the confirmatory test with a result ≥200 copies/mL, the infant will not be eligible for Step 3. * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \<LOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \<LOD after Week 48. However, infants with detectable RNA with a result \<LOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected. * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2. 4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below. 5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive): * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart. * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart. * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells/mL if 2 to less than 3 years of age; ≥750 cells/mL if 3 to less than 5 years of age; ≥500 cells/mL if 5 years of age or older). * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations. * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4. 6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry. Infant Inclusion Criteria for Step 4 1. Enrolled in Step 3. 2. Has met at least one of the following: * Plasma HIV RNA ≥LOD based on two assays. * Plasma HIV RNA ≥1000 copies/mL in the presence of fever or other sign or symptom of acute retroviral syndrome. * Confirmed or suspected diagnosis of acute retroviral syndrome. * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition. * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\<1000 cells/mL if 2 to less than 3 years of age; \<750 cells/mL if 3 to less than 5 years of age; \<500 cells/mL if 5 years of age or older). * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

  • 32515, Rush Univ./Cook County Hosp. Chicago CRS

    RECRUITING

    Chicago, Illinois, 60612, United States

  • 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

    WITHDRAWN

    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, Puerto Rico, 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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Other studies related to the condition(s) this trial covers.