Status:
COMPLETED
Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
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
4-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations. Decreasing HIV levels in infected patients can slow down dis...
Detailed Description
For PRAM 2: Evidence suggests that as a consequence of antiviral therapy, decreases in plasma HIV-1 RNA are strongly associated with a delay in clinical progression. Therefore, the drug regimens propo...
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have received the same continuous anti-HIV treatment for the past 16 weeks (missing no more than 6 weeks of treatment total during those 16 weeks).
- Are between 4 months and 17 years old (consent of parent or guardian required).
Exclusion Criteria
Patients will not be eligible if they:
- Have certain serious conditions such as cancer, an opportunistic (AIDS-related) infection, or other serious infection.
- Have ever taken any of the study drugs or any protease inhibitor.
- Are currently taking any anti-HIV drugs.
- Have taken an investigational drug within 14 days of entry into the study. (Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection studies is allowed.)
- Are taking certain other drugs.
- Are pregnant.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00001091
End Date
October 1 2000
Last Update
November 4 2021
Active Locations (55)
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1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
2
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
3
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
4
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016