Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Glaxo Wellcome

Bristol-Myers Squibb

Conditions:

HIV Infections

Eligibility:

All Genders

3-6 years

Phase:

PHASE2

Brief Summary

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 imm...

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 pr...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

July 1 1998

Estimated Enrollment :

230 Patients enrolled

Trial Details

Trial ID

NCT00000789

End Date

July 1 1998

Last Update

November 4 2021

Active Locations (54)

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Page 1 of 14 (54 locations)

1

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, United States, 90801

2

Usc La Nichd Crs

Los Angeles, California, United States, 90033

3

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, United States, 90095

4

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, United States, 94609