Lamivudine Study Halted Early On Ethical Grounds

A clinical trial of the nucleoside analog lamivudine in patients with HIV infection has been halted nearly eight months early, after the independent Data & Safety Monitoring Board decided that it would be unethical to allow the trial to continue with a placebo group.

Glaxo Wellcome, which markets the drug and BioChem Pharma, which discovered it, both announced the decision on July 23. An interim analysis of the results of the CAESAR trial (the acronym refers to the countries involved; Canada, Australia, Europe, South Africa), revealed a 54% reduction in the rate of progression to AIDS and death for HIV patients who had lamivudine added to their treatment regimen, compared to placebo.

CAESAR was started in March 1995 and was originally scheduled to complete in March 1997. It investigated the clinical efficacy of adding lamivudine or placebo to patients' existing antiretroviral therapy, or giving lamivudine plus zidovudine (Glaxo Wellcome's Retrovir) to patients who were not receiving therapy at enrollment. A third group received lamivudine plus loviride, a non-nucleoside reverse transcriptase inhibitor developed by the Janssen Research Foundation.