Document 2857 DOCN M94A2857 TI Retrospective study of zidovudine (ZDV) or didanosine (ddI) monotherapy or zalcitabine plus zidovudine (ddC + ZDV) combination therapy in patients with early AIDS. DT 9412 AU Barr M; Torres RA; St. Vincent's Hospital and Medical Center, NYC. SO Int Conf AIDS. 1994 Aug 7-12;10(1):209 (abstract no. PB0266). Unique Identifier : AIDSLINE ICA10/94369718 AB OBJECTIVE: To assess the relative efficacies of zidovudine (ZDV) and didanosine (ddI) monotherapies compared to combination therapy with zalcitabine (ddC) plus zidovudine (ZDV) in 150 patients with early AIDS. METHODS: One hundred and fifty ZDV-experienced persons attending the St. Vincent's Hospital out-patient HIV clinic who either (1) remained on zidovudine (ZDV) monotherapy or who (2) switched to didanosine (ddI) monotherapy or (3) to combination therapy with zalcitabine plus zidovudine (ddC + ZDV) were followed. The primary endpoints in this study were development of new opportunistic infections and death. Differences in rates of adverse events were also compared. RESULTS: Patients in the 3 groups were similar in terms of baseline demographics. Mean baseline CD4 count was 124 cells/mm3; mean duration of prior zidovudine, 15.5 months. Mean follow-up time was 30 weeks. Both time-adjusted mean number of hospitalizations (ZDV, 22.1; ddI, 17.0; ddC + ZDV, 19.3) and rate of new opportunistic infections (ZDV, 13.8%; ddI, 9.7%; ddC + ZDV, 24.1%) were lowest in the didanosine (ddI) group. Rate of adverse events requiring discontinuation of therapy were higher in the combination group (25.1%) than in the ddI (17.7%) or ZDV (15.8%) groups. CONCLUSION: In ZDV-experienced patients with early AIDS, switching to didanosine (ddI) may confer a clinical benefit as measured by a reduced number of hospitalizations and of new opportunistic infections. Combination therapy with zalcitabine plus zidovudine (ddC + ZDV), however, appears inferior to both ZDV and ddI monotherapies, and results in considerably more adverse reactions. DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/MORTALITY AIDS-Related Opportunistic Infections/PREVENTION & CONTROL Comparative Study Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE Drug Therapy, Combination Human Retrospective Studies Treatment Outcome Zalcitabine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL MEETING ABSTRACT SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).