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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

July 11, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000901 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

3 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00000901

Responsible Party

Study ID Numbers ^ICMJE

ACTG 395

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	John Sleasman
Study Chair:	Ross McKinney

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP