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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
San Diego, California, United States
Miami, Florida, United States
Baltimore, Maryland, United States
Pittsburgh, Pennsylvania, United States
Patients applied
Trial Officials
Fischl M
Study Chair
Richman D
Study Chair
Murray H
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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