Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children. T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).

Key facts

Study ID

NCT00001118

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Expected to finish

2002-12-01

Last updated by the study team

2021-11-01

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children may be eligible for this study if they:
• Are 3 to 12 years old (consent of parent or guardian required).
• Are HIV-positive.
• Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)
• Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.
• Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)
• Have never taken at least 1 NRTI.

You may not qualify if…

• Children will not be eligible for this study if they:
• Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.
• Are receiving chemotherapy for cancer.
• Have certain serious diseases (other than HIV) or conditions.
• Have received or are currently receiving certain medications.
• Are pregnant.

Where it is running

• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Boston City Hosp / Pediatrics — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Children's Hosp of Michigan — Detroit, Michigan, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• North Shore Univ Hosp — Great Neck, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Metropolitan Hosp Ctr — New York, New York, United States
• Harlem Hosp Ctr — New York, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States
• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Med Univ of South Carolina — Charleston, South Carolina, United States
• San Juan City Hosp — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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