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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Glaxo Wellcome
Bristol-Myers Squibb

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000789

First received: November 2, 1999
Last updated: March 30, 2012
Last Verified: March 2012
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Stavudine
Drug : Zidovudine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 230
Study Completion Date: July 1998

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.

Eligibility

Eligibility

Ages Eligible for Study: 3 Months to 6 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000789

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Bristol-Myers Squibb

Investigators

Study Chair: Kline M
Study Chair: Van Dyke R
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000789   History of Changes  
Other Study ID Numbers: ACTG 240  
  11217  
Study First Received: November 2, 1999  
Last Updated: March 30, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Stavudine

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Zidovudine
Stavudine

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.