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, randomised phase II trial.
Methodology: 142 women were screened and 100 HIV-uninfected, eligible women were enrolled, after obtaining written informed consents. Of these, 50 were randomly assigned to the study product arm and 50 to the placebo arm. Participants were requested to use the study product at least half an hour before each sexual act for 6 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 seroconversions.
Discussion: Praneem polyherbal tablet was safe for vaginal use up to 6 months with each act of sex among low-risk women. In light of the failure of Nonoxynol-9, cellulose sulphate and Carraguard in preventing HIV infections among women, additional preclinical evaluations should be undertaken urgently before moving into effectiveness studies.
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Funding: This study was funded by the National AIDS Control Organization (NACO), India.
Competing interests: None declared.
Ethics approval: The Scientific Advisory Committee, the Ethics Committee of NARI and the Drug Controller General (India) approved the conduct of the study.
Contributors: SNJ; protocol writing, development of case report form, study coordination, supervision, data collection, data analysis and interpretation, manuscript preparation. SD; data collection, study coordination, manuscript preparation. BKK, data management, data analysis, manuscript preparation. UK, data collection, study coordination, manuscript preparation. SK; laboratory procedures, monitoring and manuscript preparation. AR; laboratory procedures, monitoring and manuscript preparation. SM; protocol writing, development of case report form, study supervision, manuscript preparation.