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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Indinavir sulfate; Drug: Lamivudine; Drug: Stavudine

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 Type: Interventional
• Enrollment: 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 009367344
    • San Juan City Hosp
• United States
  • California
    • La Jolla, California, United States, 920930672
      • UCSD Med Ctr / Pediatrics / Clinical Sciences
    • San Francisco, California, United States, 941430105
      • UCSF / Moffitt Hosp - Pediatric
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale Univ Med School
  • Florida
    • Gainesville, Florida, United States, 32610
      • Univ of Florida Gainesville
    • Jacksonville, Florida, United States, 32209
      • Univ of Florida Health Science Ctr / Pediatrics
    • Miami, Florida, United States, 33161
      • Univ of Miami (Pediatric)
  • Massachusetts
    • Boston, Massachusetts, United States, 021155724
      • Children's Hosp of Boston
  • New York
    • Great Neck, New York, United States, 11021
      • North Shore Univ Hosp
    • New Hyde Park, New York, United States, 11040
      • Schneider Children's Hosp
    • New York, New York, United States, 10016
      • Bellevue Hosp / New York Univ Med Ctr
    • New York, New York, United States, 10032
      • Columbia Presbyterian Med Ctr
    • New York, New York, United States, 10032
      • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
    • Syracuse, New York, United States, 13210
      • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • North Carolina
    • Durham, North Carolina, United States, 277103499
      • Duke Univ Med Ctr
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 191044318
      • Children's Hosp of Philadelphia
  • South Carolina
    • Charleston, South Carolina, United States, 294253312
      • Med Univ of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 381052794
      • Saint Jude Children's Research Hosp of Memphis
  • Washington
    • Seattle, Washington, United States, 981050371
      • Children's Hospital & Medical Center / Seattle ACTU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Ross McKinney; Study Chair: John Sleasman

Study record dates

Study Major Dates

• Study Completion (Actual): October 1, 2000

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Stavudine; Lamivudine; RNA, Viral; Viral Load; HIV Protease Inhibitors; Indinavir; Dose-Response Relationship, Drug
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Lamivudine; Stavudine; Indinavir
• Other Study ID Numbers: ACTG 395; 11351 (DAIDS ES)