Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection

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.

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.]

Inclusion Criteria

Your child may be eligible for this study if he/she:

• Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
• Is HIV-positive.
• Is generally healthy.
• Is able to swallow medication in capsule form.
• Has never taken d4T or has never taken 3TC.
• Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

• Has a serious infection at the time of study entry.
• Has a history of severe diarrhea.
• Is unable to take any of the medications in this study for any reason.
• Has a history of certain serious illnesses.
• Has taken any protease inhibitors (PIs).
• Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
• Has taken certain medications.
• Is pregnant or breast-feeding.