Longterm Follow-Up of Patients in CSP No. 298 'Treatment of Patients withAcquired Deficiency Syndrome (AIDS) and AIDS Related Complex

摘要

This is the second annual report for the extended follow-up of patientsoriginally enrolled in the VA CSP Study No. 298. The original study was a 4-year, double-blind, placebo-controlled study of the efficacy and safety of azidothymidine (AZT: 250 mg q 4 hr, p.o.) for patients with symptomatic HIV infection and CD4 counts between 200 and 500 cells/cubic mm. In that study we compared the benefits and liabilities of initiating AZT early (i.e., at study enrollment) versus initiating it late (i.e., when AIDS occurred or CD4 counts declined to < 200 cells/cubic mm. That study ended in January 1991, finding that early AZT therapy delays the progression to AIDS but does not give a concomitant increase in survival time. The present study is a 3-year extended follow-up of the patients who survived the original study. Its goals are to assess early versus late AZT therapy in terms of long-term morbidity, toxicity, and drug resistance. For this study, the dosage of AZT is 500 mg daily, the dosage now recommended by the manufacturer and the FDA.