HEALTH-STATUS AND FUNCTION WITH ZIDOVUDINE OR ZALCITABINE AS INITIAL THERAPY FOR AIDS - A RANDOMIZED CONTROLLED TRIAL

Objective.-To evaluate the functional and health status implications o f prescribing zalcitabine or zidovudine for initial therapy of acquire d immunodeficiency syndrome (AIDS). Design.-A substudy of a randomized controlled trial. Setting.-Private and public clinics and referral ce nters. Patients.-Had human immunodeficiency virus (HIV) infection, les s than 0.20x10(9)/L (200 mu L) CD4(+) cells, and either a history of P neumocystis carinii pneumonia or symptoms of HIV infection. Fifty-eigh t percent (338/668) of main study enrollees representing 90% of enroll ees at participating sites were included in this substudy. Interventio ns.-Either zalcitabine at 0.75 mg every 8 hours plus inactive capsules identical in appearance to zidovudine or zidovudine at 200 mg (later 100 mg) every 4 hours plus inactive tablets identical in appearance to zalcitabine.Main Outcome Measures.-Results of a periodically complete d self-report survey instrument containing specific questions about sy mptom impact, disability, work, functioning, and utilization as well a s nine health and functioning scales adapted from the Medical Outcomes Study (MOS). Results.-Zalcitabine recipients were twice as likely to undergo an invasive procedure (P=.004) or be admitted to hospital(P=.0 1). Zalcitabine recipients reported greater than 40% more symptoms tha t interfered with activity (P=.001) and greater than 50% more disabili ty days (P<.01). They also had a 7% lower employment rate and a 35% lo wer monthly income, Average observed health status scores were lower i n zalcitabine recipients overall, but especially in the early portion of the study. New methods for combining survival and health status dat a showed that, over 76 weeks of study, a typical zidovudine recipient spent about 4 (10%) more weeks with at least the typical health state than did a typical zalcitabine recipient. Conclusions.-Zidovudine has substantial advantages over zalcitabine in initial monotherapy of AIDS in terms of functional outcomes such as symptom impact, disability, w ork, utilization, and health status. In this case, the differences in functional outcomes presaged differences in physiological and clinical measures. The inclusion of functional outcomes can greatly improve th e information available from a clinical trial.