Completed

A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 3 Months to 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone. Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.

Official TitleA Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection
NCT00001032
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
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

180 patients to be enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 Months to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

Inclusion Criteria Concurrent Medication: Recommended: * PCP prophylaxis. Allowed: * Intravenous and/or intramuscular immunoglobulin. * Acyclovir (no more than 30 mg/kg/day PO). * Ketoconazole (no more than 10 mg/kg/day). * Nystatin. * Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours. * Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy. * Trimethoprim / sulfamethoxazole. * Amphotericin B (no more than 1 mg/kg for 5 days/week). * Aerosolized ribavirin for bronchiolitis. * Hematopoietic agents. * Other drugs with little nephro-, hepato-, or cytotoxicity. * Nutritional support for HIV wasting syndrome or malnutrition. Patients must have: * HIV infection. * Ongoing stable AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols. * Known allergy or sensitivity to ddC. * Cardiomyopathy. Concurrent Medication: Excluded: * Biologic modifiers other than IVIG, steroids, or hematopoietic agents. * Investigational medications unless approved by protocol chair. * Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given). Patients with the following prior conditions are excluded: * History of intolerance or toxicity to AZT. * History of symptomatic pancreatitis. * History of peripheral neuropathy or abnormal nerve conduction velocity test. Prior Medication: Excluded: * Antiretroviral agents other than AZT within 2 weeks of study entry. Required: * Ongoing stable AZT therapy for more than 6 weeks duration.

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 47 locations

Suspended

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

Long Beach, United StatesOpen Long Beach Memorial Med. Ctr., Miller Children's Hosp. in Google Maps
Suspended

Usc La Nichd Crs

Los Angeles, United States
Suspended

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

Los Angeles, United States
Suspended

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

Oakland, United States
Completed47 Study Centers