CAESER Study Completed

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 Board.

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.

• Patients receiving 3TC-con-taining regimens (3TC plus AZT with or without ddI or ddC) had a 54% reduction in end-points compared to placebo recipients.
  
  
• This difference was statistically significant. The difference was also significant for mortality as an endpoint.
  
  
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• There was no apparent benefit with loviride, although subset analysis has not been completed.
  
  
• There were the expected results for CD4 count and viral burden in terms of correlation with clinical results.
• Adverse drug reactions were uncommon. Only 2-5% of patients in each group withdrew due to side effects.

These results indicate that 3TC added to AZT-containing anti-retroviral regimens is associated with a favorable clinical outcome.