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 enrollmentAugust 31, 2001

ConditionsHIV Infections

DrugsIndinavir sulfate Lamivudine Stavudine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment: 24
Locations: 19
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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. \[AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.\]

Registry

clinicaltrials.gov

Start Date

August 31, 2001

End Date

October 2000

Last Updated

4 years ago

Study Type

Interventional

Sex

All