Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children
5 other identifiers
interventional
24
2 countries
25
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
North Shore Univ Hosp
Great Neck, New York, 11021, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (4)
Kosel B, Church J, Cunningham C, Sista P, Aweeka F. Pharmacokinetics (PK) of selected doses of T-20, a fusion inhibitor, in HIV-1-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 726)
BACKGROUNDChurch JA, Cunningham C, Hughes M, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Purdue L, Hawkins E, Sista P; PACTG P1005 Study Team. Pediatric AIDS Clinical Trials Group. Safety and antiretroviral activity of chronic subcutaneous administration of T-20 in human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2002 Jul;21(7):653-9. doi: 10.1097/00006454-200207000-00010.
PMID: 12237598RESULTSoy D, Aweeka FT, Church JA, Cunningham CK, Palumbo P, Kosel BW, Sheiner LB; Pediatric AIDS Clinical Trial Group (PACTG) Study P1005 Investigators. Population pharmacokinetics of enfuvirtide in pediatric patients with human immunodeficiency virus: searching for exposure-response relationships. Clin Pharmacol Ther. 2003 Dec;74(6):569-80. doi: 10.1016/j.clpt.2003.09.002.
PMID: 14663459RESULTChurch JA, Hughes M, Chen J, Palumbo P, Mofenson LM, Delora P, Smith E, Wiznia A, Hawkins E, Sista P, Cunningham CK; Pediatric AIDS Clinical Trials Group P1005 Study Team. Long term tolerability and safety of enfuvirtide for human immunodeficiency virus 1-infected children. Pediatr Infect Dis J. 2004 Aug;23(8):713-8. doi: 10.1097/01.inf.0000133045.45316.6a.
PMID: 15295220RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joseph Church
- STUDY CHAIR
Coleen Cunningham