A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients
Zidovudine
+ Zalcitabine
+ Didanosine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone. Approximately 1200 patients are randomized in a 2:1:1:2 ratio to one of the following four treatment arms: AZT plus ddI, AZT plus ddI placebo, AZT plus ddC placebo, and AZT plus ddC. Average follow-up is 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 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
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.
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 16 locations
Community Consortium of San Francisco
San Francisco, United StatesOpen Community Consortium of San Francisco in Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesHill Health Corp
New Haven, United StatesWilmington Hosp / Med Ctr of Delaware
Wilmington, United States