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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000901
Collaborator
(none)
24
Enrollment
19
Locations
1.3
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
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
Actual Study Completion Date :
Oct 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California United States 920930672
    2 UCSF / Moffitt Hosp - Pediatric San Francisco California United States 941430105
    3 Yale Univ Med School New Haven Connecticut United States 06504
    4 Univ of Florida Gainesville Gainesville Florida United States 32610
    5 Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida United States 32209
    6 Univ of Miami (Pediatric) Miami Florida United States 33161
    7 Children's Hosp of Boston Boston Massachusetts United States 021155724
    8 North Shore Univ Hosp Great Neck New York United States 11021
    9 Schneider Children's Hosp New Hyde Park New York United States 11040
    10 Bellevue Hosp / New York Univ Med Ctr New York New York United States 10016
    11 Columbia Presbyterian Med Ctr New York New York United States 10032
    12 Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York United States 10032
    13 SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York United States 13210
    14 Duke Univ Med Ctr Durham North Carolina United States 277103499
    15 Children's Hosp of Philadelphia Philadelphia Pennsylvania United States 191044318
    16 Med Univ of South Carolina Charleston South Carolina United States 294253312
    17 Saint Jude Children's Research Hosp of Memphis Memphis Tennessee United States 381052794
    18 Children's Hospital & Medical Center / Seattle ACTU Seattle Washington United States 981050371
    19 San Juan City Hosp San Juan Puerto Rico 009367344

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: John Sleasman,
    • Study Chair: Ross McKinney,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00000901
    Other Study ID Numbers:
    • ACTG 395
    • 11351
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Oct 28, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Dose-Response Relationship, Drug
    Drug Therapy, Combination
    Stavudine
    HIV Protease Inhibitors
    Lamivudine
    Indinavir
    RNA, Viral
    Reverse Transcriptase Inhibitors
    Viral Load
    Additional relevant MeSH terms:
    Infections
    Lamivudine
    Stavudine
    Indinavir

    Study Results

    No Results Posted as of Oct 28, 2021