Large Clinical Trial Fails to Show Efficacy of Remune [Evaluation of HIV-1 Immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10⁶/L CD4 cell counts. Kahn JO, et al. JAMA 2000;284:2193]: This is a multicenter, double-blind, placebo-controlled, randomized clinical trial to determine if the addition of HIV-1 Immunogen would improve efficacy of antiretroviral therapy. There were 77 participating centers in the U.S. and over 2,500 participating patients. Criteria for inclusion were baseline CD4 count of 300-549 cells/mm³ and no AIDS-defining complications. Participants received HIV-1 Immunogen, which was inactivated, formulated with incomplete Freund adjuvant and given IM every 12 weeks. The analysis showed no difference in the two groups in terms of rate of clinical progression, death, HIV RNA levels, body weight, or CD4 percentage. The authors concluded that HIV-1 Immunogen does not work.
Comment: This is the first large clinical trial to determine if an immunologic modifier added to ART would reduce the rate of clinical progression. The results were clearly negative. This study has been the subject of some substantial controversy, which includes litigation in the form of a $7 million suit by the Immune Response Corporation, the supplier of HIV-1 Immunogen, against the principal investigator, Dr. James Kahn, and the sponsoring academic institution, the University of California at San Francisco. The apparent allegation is that some of the data were either not presented or were presented in an unnecessarily negative fashion.
posted 11/9/2000