Status:
COMPLETED
Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
3-12 years
Phase:
PHASE1
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 cer...
Detailed Description
T-20 is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein. By inhibiting the essential protein-protein surface interaction, T-20 is able to...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 2002
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00001118
End Date
December 1 2002
Last Update
November 1 2021
Active Locations (25)
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1
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
2
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
3
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
4
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105