PI Perspective #19

September 1996     View PDF

Remune Trials Recruiting

Remune (formerly HIV-1 Immunogen or the ‘Salk Immunogen’) has begun large scale studies. As reported in PI Perspective #16, in 1995 the Food and Drug Administration (FDA) held an advisory meeting on large studies of Remune. As the hearing proceeded, it was apparent why the agency called for a meeting. Despite what many feel was misleading promotion about the product, there is no clear data showing Remune has an impact on HIV disease. Early Remune studies, which included 235 people receiving the therapy, were not designed to look at its effectiveness.

The company showed data to the FDA suggesting that Remune slowed viral replication and CD4+ cell count decline, and thus might delay HIV disease progression. Contrary to the presentation, the FDA’s analysis of the data saw no differences in viral levels between people on placebo and those on the therapy. Both groups showed similar increases in viral levels, by HIV DNA, HIV RNA and p24 antigen. Nor was there a significant difference in changes in CD4+ cell counts or percentages. The FDA found the company had incorrectly reclassified some people in the placebo group as ‘progressors’, and had also reclassified as ‘non-progressors’ 5 people who had received therapy who apparently progressed in their disease. Without these erroneous “adjustments,” there was no difference in disease progression between placebo and Remune.

Remune’s likely side effects were minimal, primarily pain at the injection site and rash. It did not appear to affect viral load or CD4+ cell counts either positively or negatively. Participating in a study of Remune may disqualify a person for trials of other therapies. Some participants in studies of Remune have felt that the therapy benefited them, but their personal experiences were not reflected by the data. The bottom line for people considering participation in the Remune study is to weigh the risks and benefits, consider the pros and cons and make an informed decision.