Follansbee S, Drew L, Olson R, Pollard R, Relter W, Salgo M; International Conference on AIDS.
Int Conf AIDS. 1993 Jun 6-11; 9: 487 (abstract no. PO-B26-2113).
Davies Med. Ctr., San Francisco, CA.
OBJECTIVE: To evaluate the efficacy of ddC in the treatment of patients with AIDS or advanced ARC who have previously received less than 3 months of ZDV therapy. METHODS: 635 patients with AIDS or ARC (less than 3 months of ZDV therapy) entered this phase II/III, multicenter, double-blind, placebo-controlled, comparative, two-year trial. 320 patients initially were randomly assigned to receive ddC 0.75 mg q8h and 315 were randomized to receive ZDV 200 mg q4h. After April 1, 1990 the ZDV dosage was changed to 100 mg q4h. The primary criterion for evaluation of efficacy was patient survival. Other parameters measured were time to opportunistic infection (OI) or neoplasm, CD4 cell count, p24 antigen, weight, Karnofsky performance score, and neuropsychologic status. RESULTS: Up to the clinical cut-off date for the one-year analysis 101 (31.6%) of 320 patients in the ddC group and 73 (23.2%) of 315 patients in the ZDV group died (p = .02, log rank test). The projected probability of remaining free of an AIDS-defining OI or neoplasm at one year was 66% for patients receiving ddC and 76% for patients receiving ZDV (RR = .8, stratified Cox regression p = .15). Patients in the ZDV group had significantly greater increases from baseline CD4 cell count than did patients in the ddC group, but only during weeks 4 to 20. Change in p24 antigen status was comparable between the two study groups. Patients receiving ZDV experienced an initial increase in body weight, but began to lose weight after study week 40. Patients receiving ddC maintained their baseline weight throughout the study. CONCLUSIONS: An up to date survival analysis in this population of advanced HIV infected patients with < or = 3 months of prior ZDV will be presented at this meeting. Activity of ddC is seen in improvements from baseline in several surrogate markers of HIV activity, particularly in those with less severe disease.
Publication Types:
Keywords:
- AIDS Vaccines
- AIDS-Related Complex
- Acquired Immunodeficiency Syndrome
- Blindness
- CD4 Lymphocyte Count
- Clinical Trials as Topic
- Double-Blind Method
- HIV Infections
- HIV Seropositivity
- Humans
- Zalcitabine
- Zidovudine
Other ID:
UI: 102205104
From Meeting Abstracts