Completed

A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
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

While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS, during the second year of administration of AZT an acceleration in mortality has been observed. The reasons for this are not known at this time. The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients. Following tests to evaluate their health, patients are chosen at random to receive either AZT or ddC. AZT is given by mouth at the patients' current dose. ddC is given by mouth every 8 hours. Treatment continues for up to 12 months. Patients are required to visit the clinic every 2 weeks up to week 12 and then once a month. Blood samples are taken to monitor the safety and effectiveness of treatment.

Official TitleA Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
NCT00000682
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

120 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.

Over 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 SyndromeBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesOpportunistic InfectionsPneumoniaPneumonia, PneumocystisRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsPneumocystis InfectionsAIDS-Related Opportunistic Infections

Criteria

Inclusion Criteria Required: * Prior zidovudine (AZT) therapy for 9 months. Concurrent Medication: Allowed: * Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer. * Maintenance treatment with pyrimethamine, sulfadiazine, amphotericin, fluconazole, ketoconazole, acyclovir, or inhaled pentamidine for subjects who have recovered from toxoplasmosis, cryptococcosis, candidiasis, herpes infection, or PCP. * Dapsone for PCP. * Pyrimethamine-sulfadoxine for toxoplasmosis. * Ganciclovir (DHPG) for maintenance only for cytomegalovirus (CMV) retinitis. * Note: Any approved medications can be used to treat an opportunistic infection. All concurrent medications should be kept to a minimum and recorded. Patients must be positive for HIV by ELISA test and must have been receiving zidovudine (AZT) therapy for at least 9 months and have received AZT within 90 days prior to entry into the study. Patients may be transfusion dependent as long as no more than 3 units of blood are needed in a 21-day period and the hemoglobin does not fall below 6.4 g/dl on two consecutive occasions despite the transfusions. Exclusion Criteria Concurrent Medication: Excluded: * Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers. * Corticosteroids and chronic aspirin. * Cimetidine. * Flurazepam. * Indomethacin. * Ranitidine. * Probenecid. * Other experimental medications. Patients will be excluded from the study for the following reasons: * Removal from zidovudine (AZT) during treatment on ACTG protocol 002 for recurrent grade 4 toxicity. * Removal from prior dideoxycytidine (ddC) therapy for peripheral neuropathy = or \> grade 3. * Visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy. * Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults). Prior Medication: Excluded: * Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers. * Patients may not have visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy.

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 5 locations

Suspended

USC CRS

Los Angeles, United StatesOpen USC CRS in Google Maps
Suspended

Ucsd, Avrc Crs

San Diego, United States
Suspended

Univ. of Miami AIDS CRS

Miami, United States
Suspended

Johns Hopkins Adult AIDS CRS

Baltimore, United States
Completed5 Study Centers