BioCentury
ARTICLE | Clinical News

Anti-HIV gels miss endpoint

February 10, 2009 2:12 AM UTC

PRO 2000 gel from Indevus (NASDAQ:IDEV) and BufferGel from ReProtect (Baltimore, Md.) both missed the primary endpoint in the Phase II/IIb HPTN 035 trial to prevent infection of women by HIV. Indevus did say that women receiving PRO 2000, a synthetic topical vaginal microbicide derived from naphthalene sulfate, had a 30% lower risk of acquiring HIV infection than those who received a placebo or no gel. The PRO 2000 arm had an HIV infection rate of 2.7/100 woman-years, which was not significantly lower than the rates for the placebo gel arm (3.91/100 woman-years, p=0.1) or the no gel arm (4.02/100 woman-years, p=0.06). BufferGel, a microbicidal spermicide, had an HIV infection rate of 4.14/100 woman-years. ...