A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children.

SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.

At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.

Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.

Study Type

Interventional

Enrollment

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
      • San Juan, Puerto Rico, 00936
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Puerto Rico, 00936
        • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • United States
    • California
      • Long Beach, California, United States, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles, California, United States, 90033
        • Usc La Nichd Crs
      • Los Angeles, California, United States, 90095
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Oakland, California, United States, 94609
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • San Diego, California, United States, 92093
        • UCSD Maternal, Child, and Adolescent HIV CRS
      • San Francisco, California, United States, 94143
        • UCSF Pediatric AIDS CRS
      • Torrance, California, United States, 90502
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Colorado
      • Aurora, Colorado, United States, 80218
        • Univ. of Colorado Denver NICHD CRS
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
      • New Haven, Connecticut, United States, 06504
        • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Med. Ctr., ACTU
      • Washington, District of Columbia, United States, 20060
        • Howard Univ. Washington DC NICHD CRS
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ. of Florida Jacksonville NICHD CRS
      • Miami, Florida, United States, 33161
        • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp.
      • Chicago, Illinois, United States, 60614
        • Chicago Children's CRS
      • Chicago, Illinois, United States, 60637
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
      • Chicago, Illinois, United States, 60612
        • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane/LSU Maternal/Child CRS
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Boston, Massachusetts, United States, 02118
        • BMC, Div. of Ped Infectious Diseases
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, United States, 01655
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan NICHD CRS
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Univ. Hosp.
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ - Robert Wood Johnson
      • Paterson, New Jersey, United States
        • St. Joseph's Hosp. & Med. Ctr. of New Jersey
    • New York
      • Albany, New York, United States, 12208
        • Children's Hospital at Albany Medical Center, Dept. of Peds.
      • Bronx, New York, United States, 10457
        • Bronx-Lebanon Hosp. IMPAACT CRS
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • Great Neck, New York, United States, 11021
        • North Shore-Long Island Jewish Health System, Dept. of Peds.
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hosp., Div. of Infectious Diseases
      • New York, New York, United States, 10032
        • Columbia IMPAACT CRS
      • New York, New York, United States, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, United States, 10016
        • NYU Med. Ctr., Dept. of Medicine
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr.
      • New York, New York, United States, 10029
        • Metropolitan Hosp. NICHD CRS
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook NICHD CRS
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
      • Durham, North Carolina, United States, 27710
        • DUMC Ped. CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hosp. of Philadelphia IMPAACT CRS
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hosp. for Children
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude/UTHSC CRS
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Med. Ctr. Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS
    • Washington
      • Seattle, Washington, United States, 98105
        • UW School of Medicine - CHRMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Recommended:

  • PCP prophylaxis.

Allowed:

  • Immunoglobulin.
  • Erythropoietin, G-CSF, and GM-CSF.
  • Corticosteroids.
  • Ethionamide or isoniazid for TB if no alternative is available.
  • Pyridoxine (up to 50 mg/day) as vitamin supplement.

Patients must have:

  • Symptomatic HIV infection.
  • No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG).
  • Consent of parent or guardian.

NOTE:

  • Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted.

Prior Medication:

Allowed:

  • Maternal immunomodulator or antiretroviral therapy (including during pregnancy).
  • Antiretroviral therapy prior to 2 months.
  • Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Current grade 3 or worse neuropathy / lower motor neuropathy.
  • Other grade 3 or worse clinical or laboratory toxicities.
  • Known intolerance to either AZT or d4T.

Concurrent Medication:

Excluded:

  • Chemotherapy for active malignancy.

Patients with the following prior conditions are excluded:

  • History of grade 3 or worse neuropathy/lower motor neuropathy.

Prior Medication:

Excluded:

  • More than 6 weeks of prior antiretroviral or immunomodulator therapy.
  • Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Bristol-Myers Squibb
Glaxo Wellcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

July 1, 1998

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)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 240
  • 11217 (REGISTRY: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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