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

Zidovudine

+ Zalcitabine
Drug
Who is being recruted

HIV Infections

Over 12 Years
How is the trial designed

Treatment Study

Phase 3
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
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To evaluate the efficacy of AZT versus ddC in terms of survival, antiviral effects, neurological status, and health status in patients post Pneumocystis carinii pneumonia (PCP) who received long-term AZT therapy in ACTG protocol 002 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. 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 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 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
120 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 participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

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.
Over 12 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 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 CRSLos Angeles, United StatesSee the location
Suspended
Ucsd, Avrc CrsSan Diego, United States
Suspended
Univ. of Miami AIDS CRSMiami, United States
Suspended
Johns Hopkins Adult AIDS CRSBaltimore, United States

Completed5 Study Centers