NCT00000901CompletedPhase 1
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
National Institute of Allergy and Infectious Diseases (NIAID)19 sites in 2 countries24 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 19
Study Overview
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.]
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 3 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (19)
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