Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00000901
- Brief Summary
The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.
- Detailed Description
In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. \[AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (19)
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States