CAESER (an acronym based on the participating sites: Canada, Australia,
Europe, and South Africa) is a clinical trial comparing multiple nucleoside
analogues and loviride, a non-nucleoside reverse transcriptase inhibitor, in
1,892 patients with advanced HIV infection. Initiated in March 1995 and
scheduled to end in March 1997, CAESER was prematurely discontinued based on
recommendations from the July 25, 1996 meeting of the Data and Safety Monitoring
Entry criteria were a CD4 cell count of 25-250/mm3. Patients were receiving AZT, AZT + ddI, or AZT + ddC and were randomized to the following additional agents: 1) 3TC, 2) 3TC + loviride, or 3) placebo.
End points in the study were standard clinical criteria: an AIDS-defining opportunistic infection or tumor or death. Results of the study are outlined below.
These results indicate that 3TC added to AZT-containing anti-retroviral regimens is associated with a favorable clinical outcome.