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NCT00000901 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000901
Other study ID # ACTG 395
Secondary ID 11351
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date October 2000

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.]

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date October 2000
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Years to 15 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Lamivudine

• Stavudine

Locations
Country Name City State
Puerto Rico San Juan City Hosp San Juan
United States Children's Hosp of Boston Boston Massachusetts
United States Med Univ of South Carolina Charleston South Carolina
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of Florida Gainesville Gainesville Florida
United States North Shore Univ Hosp Great Neck New York
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Yale Univ Med School New Haven Connecticut
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 Columbia Presbyterian Med Ctr New York New York
United States Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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