RecruitingPhase 1Phase 2NCT02140255

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

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

1,120 participants

Start Date

Jan 23, 2015

Study Type

INTERVENTIONAL

Conditions

HIV Infection

Summary

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.

Eligibility

Max Age: 48 Hours

Plain Language Summary

Simplified for easier understanding

This trial is studying whether starting HIV-positive babies on very aggressive (intensive) antiretroviral therapy (ART) very early in life — within 48 hours of birth — can achieve HIV remission, meaning the virus is suppressed to undetectable levels that last even if treatment is paused later. **You may be eligible if...** - You are a mother confirmed or presumed to have HIV infection - You did not receive antiretroviral drugs during the current pregnancy - Your baby is 48 hours old or younger, weighs at least 2 kg, and was born at 36 weeks gestation or later - Your baby has not yet been confirmed HIV-positive (enrollment happens before test results) - You are willing to consent on behalf of your infant **You may NOT be eligible if...** - The mother received antiretroviral drugs during pregnancy - The baby is premature (less than 36 weeks) or too small (under 2 kg) - The mother has previously enrolled another child in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNucleoside Reverse Transcriptase Inhibitors (NRTIs)

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

DRUGNevirapine (NVP)

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

DRUGLopinavir/Ritonavir (LPV/r)

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

DRUGRaltegravir (RAL)

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

DRUGVRC01

40 mg/kg administered subcutaneously.

DRUGDolutegravir (DTG)

Dosed according to study step/participant's age/participant's weight

DRUGVRC07-523LS

40 mg/kg administered subcutaneously.

Locations(46)

4601, University of California, San Diego Clinical Research Site

La Jolla, California, United States

5048, University of Southern California Clinical Research Site

Los Angeles, California, United States

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

Los Angeles, California, United States

5052, University of Colorado, Denver Clinical Research Site

Aurora, Colorado, United States

5055, South Florida CDTC Fort Lauderdale Clinical Research Site

Fort Lauderdale, Florida, United States

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

Jacksonville, Florida, United States

5127, Pediatric Perinatal HIV Clinical Research Site

Miami, Florida, United States

Emory University School of Medicine NICHD CRS

Atlanta, Georgia, United States

5083, Rush University Cook County Hospital Clinical Research Site

Chicago, Illinois, United States

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

Chicago, Illinois, United States

5092, Johns Hopkins Clinical Research Site

Baltimore, Maryland, United States

Boston Medical Center Ped. HIV Program NICHD CRS

Boston, Massachusetts, United States

5040, SUNY Stony Brook Clinical Research Site

Stony Brook, New York, United States

5114, Bronx Lebanon Hospital Center Clinical Research Site

The Bronx, New York, United States

5013, Jacobi Medical Center Clinical Research Site

The Bronx, New York, United States

Philadelphia IMPAACT Unit CRS

Philadelphia, Pennsylvania, United States

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

Memphis, Tennessee, United States

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

Houston, Texas, United States

Seattle Children's Research Institute CRS

Seattle, Washington, United States

Univ. of Washington NICHD CRS

Seattle, Washington, United States

Hosp. General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires, Argentina

Hospital Nossa Senhora da Conceicao NICHD CRS

Porto Alegre, Rio Greande Do Sul, Brazil

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

Minas Gerais, Brazil

5072, Hospital Federal dos Servidores do Estado Clinical Research Site

Rio de Janeiro, Brazil

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

Rio de Janeiro, Brazil

5097, Hospital Geral de Nova Igaucu Clinical Research Site

Rio de Janeiro, Brazil

5074, University of Sao Paulo Clinical Research Site

São Paulo, Brazil

30022, Les Centres GHESKIO Clinical Research Site

Port-au-Prince, Haiti

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

Kericho, Kenya

12001, Malawi Clinical Research Site

Lilongwe, Central Region, Malawi

30301, Blantyre Clinical Research Site

Blantyre, Malawi

5129, University of Puerto Rico Gamma Project Clinical Research Site

San Juan, PR, Puerto Rico

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico

Soweto IMPAACT CRS

Johannesburg, Gauteng, South Africa

Wits RHI Shandukani Research Centre CRS

Johannesburg, Gauteng, South Africa

30300, Umlazi Clinical Research Site

Durban, KwaZulu-Natal, South Africa

8950, FAMCRU Clinical Research Site

Tygerberg, Western Cape, South Africa

5118, Kilimanjaro Christian Medical Centre Clinical Research Site

Moshi, Tanzania

5115, Siriraj Hospital Mahidol University Clinical Research Site

Bangkok, Bangkoknoi, Thailand

5116, Chiangrai Prachanukroh Hospital Clinical Research Site

Chiang Mai, Thailand

31798, Baylor-Uganda Clinical Research Site

Kampala, Uganda

MU-JHU Care Limited CRS

Kampala, Uganda

George CRS

Lusaka, Zambia

30303, Saint Mary's Clinical Research Site

Chitungwiza, Zimbabwe

30306, Seke North Clinical Research Site

Chitungwiza, Zimbabwe

31890, Harare Family Care Clinical Research Site

Harare, Zimbabwe

View Full Details on ClinicalTrials.gov

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NCT02140255

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