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A randomized, comparative trial of ZDV versus ZDV plus ddI versus ZDV plus ddC in persons with CD4 cell counts of less than 200/mm3.
Saravolatz L; Collins G; Hodges J; Winslow D; NIAID, Bethesda, Maryland.
November 30, 1996
3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:161. Unique

Despite widespread use of combination nucleoside therapy in patients with AIDS (1993 CDC definition), a clinical benefit has yet to be demonstrated in terms of delaying opportunistic diseases or death. CPCRA 007 was designed to compare the efficacy of ZDV alone, ZDV given with ddI, and ZDV given with ddC in delaying disease progression or death in patients with AIDS. 1113 patients (254 antiretroviral naive, 859 antiretroviral experienced) were randomized openly to ZDV (600mg/d) and ddI or ZDV and ddC and then randomized in a double blind fashion, in a 2:1 ratio, either to active ddI (400 mg/d) or its placebo or to active ddC (2.25 mg/d) or its placebo. Baseline characteristics were well balanced among treatment arms and overall the participants were: 92% male, 33% African American, 10% Hispanic, 68% homosexual, and 23% intravenous drug users. The mean CD4+ count was 119 cells/mm3 and the median prior ZDV use was 6 months. Prior AIDS defining opportunistic infections and prior Pneumocystis carinii pneumonia (PCP) were present on enrollment in 32% and 23% of patients respectively. PCP prophylaxis was required for all participants and did not differ significantly in terms of the agent selected. All patients were followed for at least 17 months and the median followup was 35 months. 4% of enrollees were lost to followup. The mean time on blinded study drugs were 13, 14 and 14 in the ZDV + ddI, ZDV + ddC, and ZDV only groups, respectively. The study closed to followup on November 30, 1995 and is currently under analysis. Difference in treatment arms have been analyzed and detailed results will be reported. The study has important implications for patient management.

Acquired Immunodeficiency Syndrome/COMPLICATIONS/*DRUG THERAPY/ PHYSIOPATHOLOGY Antiviral Agents/*THERAPEUTIC USE CD4 Lymphocyte Count Comparative Study Didanosine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Drug Therapy, Combination Female Human Male Pneumonia, Pneumocystis carinii/PREVENTION & CONTROL Zalcitabine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE ABSTRACT