๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-17

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission (NCT02140255)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: 4601, University of California, San Diego Clinical Research Site โ€” La Jolla, California

Age range: Not specified to 48 Hours

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (46 Sites)

Showing the first 25 of 46 sites.

  • 4601, University of California, San Diego Clinical Research Site โ€” La Jolla, California
  • 5048, University of Southern California Clinical Research Site โ€” Los Angeles, California
  • 5112, David Geffen School of Medicine at UCLA Clinical Research Site โ€” Los Angeles, California
  • 5052, University of Colorado, Denver Clinical Research Site โ€” Aurora, Colorado
  • 5055, South Florida CDTC Fort Lauderdale Clinical Research Site โ€” Fort Lauderdale, Florida
  • 5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site โ€” Jacksonville, Florida
  • 5127, Pediatric Perinatal HIV Clinical Research Site โ€” Miami, Florida
  • Emory University School of Medicine NICHD CRS โ€” Atlanta, Georgia
  • 5083, Rush University Cook County Hospital Clinical Research Site โ€” Chicago, Illinois
  • 4001, Lurie Children's Hospital of Chicago Clinical Research Site โ€” Chicago, Illinois
  • 5092, Johns Hopkins Clinical Research Site โ€” Baltimore, Maryland
  • Boston Medical Center Ped. HIV Program NICHD CRS โ€” Boston, Massachusetts
  • 5040, SUNY Stony Brook Clinical Research Site โ€” Stony Brook, New York
  • 5114, Bronx Lebanon Hospital Center Clinical Research Site โ€” The Bronx, New York
  • 5013, Jacobi Medical Center Clinical Research Site โ€” The Bronx, New York
  • Philadelphia IMPAACT Unit CRS โ€” Philadelphia, Pennsylvania
  • 6501, St Jude Children's Research Hospital Clinical Research Site โ€” Memphis, Tennessee
  • 5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site โ€” Houston, Texas
  • Seattle Children's Research Institute CRS โ€” Seattle, Washington
  • Univ. of Washington NICHD CRS โ€” Seattle, Washington
  • Hosp. General de Agudos Buenos Aires Argentina NICHD CRS โ€” Buenos Aires,
  • Hospital Nossa Senhora da Conceicao NICHD CRS โ€” Porto Alegre, Rio Greande Do Sul
  • 5073, School of Medicine Federal University Minas Gerais Clinical Research Site โ€” Minas Gerais,
  • 5072, Hospital Federal dos Servidores do Estado Clinical Research Site โ€” Rio de Janeiro,
  • 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site โ€” Rio de Janeiro,

๐Ÿ“ž Contact the Study Coordinator

Phone: (919) 627-6445

Email: acoletti@fhi360.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All HIV Infection clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—