Completed

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

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What is being tested

Stavudine

+ Zidovudine
Drug
Who is being recruted

HIV Infections

From 3 Months to 6 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
230 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 3 Months to 6 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 54 locations
Suspended
Long Beach Memorial Med. Ctr., Miller Children's Hosp.Long Beach, United StatesSee the location
Suspended
Usc La Nichd CrsLos Angeles, United States
Suspended
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRSLos Angeles, United States
Suspended
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.Oakland, United States

Completed54 Study Centers