COMPARISON OF ANTIRETROVIRAL ACTIVITY OF 3 COMBINATION REGIMENS IN HIV+ PATIENTS

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The objective of the protocol is to compare the antiretroviral activity, both in magnitude and duration, as measured by HIN-RNA and CD4 counts as well as the safety profile of several therapies in HIV+ patients. This originally 24-week study had been extended to Week 144 with Amendment 6 and now has been extended to February 28, 2001. The purpose of the amendment was to extend the study until all patients have completed 120 weeks, to change the visit frequency to quarterly, to decrease study evaluations for each patient, and to add abdominal CT scanning of patients, allowing fat distribution to be monitored. This open-label trial involving double and triple therapy with the drugs Indinavir, ZDV, 3TC, and DMP266. DMP266 is a potent non-nucleoside reverse transcriptase inhibitor which, in vitro, inhibits HIV production from infected cells. Because of this study and others, the FDA approved DMP266 and the drug is now available as Sustiva.