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:
Collaborators:
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
  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: Endpoint Classification: Pharmacokinetics Study
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

Resource links provided by NLM:


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

Estimated 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

Ages Eligible for Study:   3 Months to 6 Years
Genders Eligible for Study:   Both
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
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

  Show 54 Study Locations
Sponsors and Collaborators
Glaxo Wellcome
Bristol-Myers Squibb
Investigators
Study Chair: Kline M
Study Chair: Van Dyke R
  More Information

Additional Information:
Publications:
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
Health Authority: United States: Federal Government

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Stavudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2014