Use of MRI to quantify intra-vaginal gel distribution in human subjects: preliminary analysis of the candidate gel formulation for the Cyanovirin-N trial.
Rosen M, Pretorius S, Barnhart K, Timbers K, Hummel A, Shera D, Malinoski F
University of Pennsylvania
Six female subjects were studied with MRI for quantification of intra-vaginal distribution and spread of candidate gel formulations for the upcoming clinical trial of intra-vaginal cyanovirin-N for prevention of HIV transmission. Gadolinium chelate was added to four different candidate gel formulation (without microbicide). These were then inserted intravaginally into female volunteers for evaluation of intra-vaginal spread of gel and total vaginal surface coverage. Effects of gel formulation, time between insertion and imaging, and simulated intercourse were studied.