Status:
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 A...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1992
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00000682
End Date
September 1 1992
Last Update
November 3 2021
Active Locations (5)
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1
USC CRS
Los Angeles, California, United States, 90033
2
Ucsd, Avrc Crs
San Diego, California, United States, 92103
3
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
4
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287