Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

1,120

Participants

Timeline

Start Date

January 23, 2015

Primary Completion Date

January 31, 2028

Study Completion Date

December 31, 2031

Conditions
HIV Infection
Interventions
DRUG

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

DRUG

Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

DRUG

Lopinavir/Ritonavir (LPV/r)

Administered orally. Dosed according to study step and participant's age.

DRUG

Raltegravir (RAL)

Administered orally. Dosed according to study step and participant's age.

DRUG

VRC01

40 mg/kg administered subcutaneously.

DRUG

DTG

Administered orally. Dosed according to participant's weight.

DRUG

VRC07-523LS

40 mg/kg administered subcutaneously.

Trial Locations (50)

1862

COMPLETED

Soweto IMPAACT CRS, Johannesburg

2001

COMPLETED

Wits RHI Shandukani Research Centre CRS, Johannesburg

4001

RECRUITING

30300, Umlazi Clinical Research Site, Durban

7505

RECRUITING

8950, FAMCRU Clinical Research Site, Tygerberg

9104

WITHDRAWN

Philadelphia IMPAACT Unit CRS, Philadelphia

10101

COMPLETED

George CRS, Lusaka

10457

RECRUITING

5114, Bronx Lebanon Hospital Center Clinical Research Site, The Bronx

10461

RECRUITING

5013, Jacobi Medical Center Clinical Research Site, The Bronx

10700

RECRUITING

5115, Siriraj Hospital Mahidol University Clinical Research Site, Bangkok

11794

WITHDRAWN

5040, SUNY Stony Brook Clinical Research Site, Stony Brook

20200

RECRUITING

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

21287

RECRUITING

5092, Johns Hopkins Clinical Research Site, Baltimore

26030

RECRUITING

5097, Hospital Geral de Nova Igaucu Clinical Research Site, Rio de Janeiro

30322

WITHDRAWN

Emory University School of Medicine NICHD CRS, Atlanta

32209

RECRUITING

5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site, Jacksonville

33136

RECRUITING

5127, Pediatric Perinatal HIV Clinical Research Site, Miami

COMPLETED

University of Miami CRS, Miami

33316

COMPLETED

5055, South Florida CDTC Fort Lauderdale Clinical Research Site, Fort Lauderdale

50100

RECRUITING

5116, Chiangrai Prachanukroh Hospital Clinical Research Site, Chiang Mai

60612

RECRUITING

5083, Rush University Cook County Hospital Clinical Research Site, Chicago

77030

RECRUITING

5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site, Houston

80045

RECRUITING

5052, University of Colorado, Denver Clinical Research Site, Aurora

90089

RECRUITING

5048, University of Southern California Clinical Research Site, Los Angeles

98101

WITHDRAWN

Seattle Children's Research Institute CRS, Seattle

98195

WITHDRAWN

Univ. of Washington NICHD CRS, Seattle

92093-0672

COMPLETED

4601, University of California, San Diego Clinical Research Site, La Jolla

90095-1752

RECRUITING

5112, David Geffen School of Medicine at UCLA Clinical Research Site, Los Angeles

60614-3393

RECRUITING

4001, Lurie Children's Hospital of Chicago Clinical Research Site, Chicago

02118

WITHDRAWN

Boston Medical Center Ped. HIV Program NICHD CRS, Boston

38105-3678

RECRUITING

6501, St Jude Children's Research Hospital Clinical Research Site, Memphis

77030-2399

WITHDRAWN

Texas Children's Hospital CRS, Houston

C1221ADC

WITHDRAWN

Hosp. General de Agudos Buenos Aires Argentina NICHD CRS, Buenos Aires

91350-200

COMPLETED

Hospital Nossa Senhora da Conceicao NICHD CRS, Porto Alegre

30.130-100

RECRUITING

5073, School of Medicine Federal University Minas Gerais Clinical Research Site, Minas Gerais

20221-903

COMPLETED

5072, Hospital Federal dose Servidores do Estado Clinical Research Site, Rio de Janeiro

21941-612

RECRUITING

5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site, Rio de Janeiro

14049-900

RECRUITING

5074, University of Sao Paulo Clinical Research Site, São Paulo

HT-6110

RECRUITING

30022, Les Centres GHESKIO Clinical Research Site, Port-au-Prince

Unknown

RECRUITING

12001, Malawi Clinical Research Site, Lilongwe

RECRUITING

30301, Blantyre Clinical Research Site, Blantyre

RECRUITING

5118, Kilimanjaro Christian Medical Centre Clinical Research Site, Moshi

RECRUITING

31798, Baylor-Uganda Clinical Research Site, Kampala

COMPLETED

MU-JHU Care Limited CRS, Kampala

WITHDRAWN

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala

RECRUITING

30303, Saint Mary's Clinical Research Site, Chitungwiza

RECRUITING

30306, Seke North Clinical Research Site, Chitungwiza

RECRUITING

31890, Harare Family Care Clinical Research Site, Harare

00935

RECRUITING

5129, University of Puerto Rico Gamma Project Clinical Research Site, San Juan

WITHDRAWN

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS, San Juan

00936

WITHDRAWN

San Juan City Hosp. PR NICHD CRS, San Juan

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH