Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 proposed in this study are designed to result in a much larger sustained drop in plasma HIV-1 RNA and greater clinical benefit. Further intent of this study is to evaluate the virologic and therapeutic potential of novel combinations of antiretrovirals and to better define the pharmacokinetics and drug-drug interactions of therapies included in this regimen.

The Master PRAM schema is designed to al...

Gender

ALL

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.

Trial Officials