Status:
COMPLETED
A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related co...
Detailed Description
Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains...
Eligibility Criteria
Inclusion Criteria
Required:
- Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma).
- CD4+ cell count = or < 200/mm3 or = or < 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection.
- Current PCP prophylaxis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse.
- Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy.
- Stage 2 or worse (moderate) AIDS Dementia Complex.
- Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy.
Concurrent Medication:
Excluded:
- Acute therapy for active AIDS-defining opportunistic infection.
- Systemic chemotherapy for malignancy.
- Antiretroviral therapy other than that provided by this study.
Patients with the following prior conditions are excluded:
- History of pancreatitis or peripheral neuropathy of grade 2 or worse.
- History of intolerance to the study drugs at entry doses and/or frequencies.
- History of phenylketonuria.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
December 1 1995
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00001022
End Date
December 1 1995
Last Update
November 4 2021
Active Locations (16)
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1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
3
Hill Health Corp
New Haven, Connecticut, United States, 06519
4
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899