Actively Recruiting
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-28
1120
Participants Needed
46
Research Sites
883 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
CONDITIONS
Official Title
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers with presumed or confirmed HIV infection based on antibody or confirmatory testing
- Mothers able and willing to provide written informed consent for themselves and their infant
- Mothers not previously enrolled in this study with another infant
- Mothers who did not receive antiretrovirals during current pregnancy
- Infants less than or equal to 48 hours old
- Infants born at 37 weeks gestational age or later
- Infants weighing at least 2 kilograms at birth
- Infants able to take antiretroviral drugs by mouth, nasogastric tube, or gastrostomy tube
- Infants without other clinically significant diseases or findings that would interfere with study participation
- Infants whose mother is eligible per inclusion criteria
- Infants enrolled in Step 1 with confirmed in utero HIV infection for Step 2
- Infants and guardians willing to provide informed consent for participation in subsequent study steps
- Infants meeting viral suppression and immune criteria for treatment interruption in Step 3
- Infants who have permanently stopped breastfeeding for at least six weeks before certain testing
You will not qualify if you...
- Mothers who received antiretroviral drugs during the current pregnancy
- Infants with clinically significant diseases other than HIV that could interfere with participation
- Infants not meeting age, weight, or HIV infection confirmation criteria
- Infants unable to take antiretroviral therapy by mouth or feeding tube
- Infants with plasma HIV RNA levels above specified thresholds during monitoring
- Infants breastfeeding or exposed to breast milk within six weeks prior to testing
- Infants with immune cell counts below defined age-specific limits
- Infants assessed by investigators as unlikely to adhere to study procedures
- Infants previously enrolled in this study with another infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 46 locations
1
4601, University of California, San Diego Clinical Research Site
La Jolla, California, United States, 92093-0672
Completed
2
5048, University of Southern California Clinical Research Site
Los Angeles, California, United States, 90089
Actively Recruiting
3
5112, David Geffen School of Medicine at UCLA Clinical Research Site
Los Angeles, California, United States, 90095-1752
Actively Recruiting
4
5052, University of Colorado, Denver Clinical Research Site
Aurora, Colorado, United States, 80045
Actively Recruiting
5
5055, South Florida CDTC Fort Lauderdale Clinical Research Site
Fort Lauderdale, Florida, United States, 33316
Completed
6
5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site
Jacksonville, Florida, United States, 32209
Actively Recruiting
7
5127, Pediatric Perinatal HIV Clinical Research Site
Miami, Florida, United States, 33136
Actively Recruiting
8
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, United States, 30322
Withdrawn
9
5083, Rush University Cook County Hospital Clinical Research Site
Chicago, Illinois, United States, 60612
Actively Recruiting
10
4001, Lurie Children's Hospital of Chicago Clinical Research Site
Chicago, Illinois, United States, 60614-3393
Actively Recruiting
11
5092, Johns Hopkins Clinical Research Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
12
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, United States, 02118
Withdrawn
13
5040, SUNY Stony Brook Clinical Research Site
Stony Brook, New York, United States, 11794
Withdrawn
14
5114, Bronx Lebanon Hospital Center Clinical Research Site
The Bronx, New York, United States, 10457
Actively Recruiting
15
5013, Jacobi Medical Center Clinical Research Site
The Bronx, New York, United States, 10461
Actively Recruiting
16
Philadelphia IMPAACT Unit CRS
Philadelphia, Pennsylvania, United States, 9104
Withdrawn
17
6501, St Jude Children's Research Hospital Clinical Research Site
Memphis, Tennessee, United States, 38105-3678
Actively Recruiting
18
5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site
Houston, Texas, United States, 77030
Actively Recruiting
19
Seattle Children's Research Institute CRS
Seattle, Washington, United States, 98101
Withdrawn
20
Univ. of Washington NICHD CRS
Seattle, Washington, United States, 98195
Withdrawn
21
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS
Buenos Aires, Argentina, C1221ADC
Withdrawn
22
Hospital Nossa Senhora da Conceicao NICHD CRS
Porto Alegre, Rio Greande Do Sul, Brazil, 91350-200
Completed
23
5073, School of Medicine Federal University Minas Gerais Clinical Research Site
Minas Gerais, Brazil, 30.130-100
Actively Recruiting
24
5072, Hospital Federal dos Servidores do Estado Clinical Research Site
Rio de Janeiro, Brazil, 20221-903
Completed
25
5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
Rio de Janeiro, Brazil, 21941-612
Actively Recruiting
26
5097, Hospital Geral de Nova Igaucu Clinical Research Site
Rio de Janeiro, Brazil, 26030
Actively Recruiting
27
5074, University of Sao Paulo Clinical Research Site
São Paulo, Brazil, 14049-900
Completed
28
30022, Les Centres GHESKIO Clinical Research Site
Port-au-Prince, Haiti, HT-6110
Actively Recruiting
29
5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
Kericho, Kenya, 20200
Actively Recruiting
30
12001, Malawi Clinical Research Site
Lilongwe, Central Region, Malawi
Actively Recruiting
31
30301, Blantyre Clinical Research Site
Blantyre, Malawi
Actively Recruiting
32
5129, University of Puerto Rico Gamma Project Clinical Research Site
San Juan, PR, Puerto Rico, 00935
Actively Recruiting
33
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Withdrawn
34
Soweto IMPAACT CRS
Johannesburg, Gauteng, South Africa, 1862
Completed
35
Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, South Africa, 2001
Completed
36
30300, Umlazi Clinical Research Site
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
37
8950, FAMCRU Clinical Research Site
Tygerberg, Western Cape, South Africa, 7505
Completed
38
5118, Kilimanjaro Christian Medical Centre Clinical Research Site
Moshi, Tanzania
Actively Recruiting
39
5115, Siriraj Hospital Mahidol University Clinical Research Site
Bangkok, Bangkoknoi, Thailand, 10700
Actively Recruiting
40
5116, Chiangrai Prachanukroh Hospital Clinical Research Site
Chiang Mai, Thailand, 50100
Actively Recruiting
41
31798, Baylor-Uganda Clinical Research Site
Kampala, Uganda
Actively Recruiting
42
MU-JHU Care Limited CRS
Kampala, Uganda
Completed
43
George CRS
Lusaka, Zambia, 10101
Completed
44
30303, Saint Mary's Clinical Research Site
Chitungwiza, Zimbabwe
Actively Recruiting
45
30306, Seke North Clinical Research Site
Chitungwiza, Zimbabwe
Actively Recruiting
46
31890, Harare Family Care Clinical Research Site
Harare, Zimbabwe
Actively Recruiting
Research Team
A
Anne Coletti, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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