Background: Praneem, a candidate vaginal microbicide with reported anti-HIV and contraceptive properties was evaluated for its long-term safety through a double-blind, placebo controlled, randomized Phase II trial.
Methodology: We screened 142 women and enrolled 100 HIV un-infected, eligible women, after obtaining their written informed consents. Of these, 50 were randomized in study product arm and 50 in the placebo arm. Participants were requested to use the study product at least half an hour before each sexual act for six months.
Results: Participants in both treatment groups contributed 601 person months of follow up and 95% of the participants completed the last follow up. Although transient genital discomfort was the main reported adverse experience, none of the study participants discontinued product use. Most of the adverse events were mild and there were no serious adverse events related to study product use and no HIV sero-conversions.
Discussion: Praneem Polyherbal Tablet was safe for vaginal use up to 6 months with each act of sex among low risk women. However in light of the failure of Nonoxynol-9, Cellulose Sulphate and Carraguard in preventing HIV infections among women, additional preclinical evaluations should be taken up urgently before moving into effectiveness studies.