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Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00000901•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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

Eligibility

Age

3 - 15 years

Sex

ALL

Healthy Volunteers

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.

Locations (19)

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, United States

Yale Univ Med School

New Haven, Connecticut, United States

Univ of Florida Gainesville

Gainesville, Florida, United States

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States

Univ of Miami (Pediatric)

Miami, Florida, United States

Children's Hosp of Boston

Boston, Massachusetts, United States

North Shore Univ Hosp

Great Neck, New York, United States

Schneider Children's Hosp

New Hyde Park, New York, United States

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Key Dates

Completion Date

October 1, 2000

Last Updated

October 28, 2021

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Indinavir sulfate

DRUG

Lamivudine

DRUG

Stavudine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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