title: Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India.
abstract: BACKGROUND
  The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% PRO 2000 Gel for fourteen days in HIV un-infected women at lower as well as higher risk for HIV acquisition, in Pune, India.
  
  
  METHODS
  Forty-two eligible volunteers (30 low-risk and 12 high-risk) were given 0.5% PRO 2000 Gel for intra-vaginal application twice daily for 14 consecutive days.
  
  
  RESULTS
  Twenty-four participants (57%, 95% CI 41%-72%) experienced at least one adverse event (AE) judged to be possibly related to the product use. There were 17 (40%, 95% CI 26%-57%) mild AEs and 7 (17%, 95% CI 7%-31%) moderate AEs. There were no serious adverse events and no AEs judged probably or definitely related to product use. Genitourinary discomfort was reported by 2/30 (6.67%) participants in the low-risk cohort as compared to 4/12 (33.3%) women in the high-risk cohort (p = 0.03). Intermenstrual bleeding was reported in 2/30 (6.7%, 95% CI 1.0-22.1) women from the low risk cohort and 3/12 (25%, 95% CI 5.5-57.2) women from the high-risk cohort. One participant showed mild elevation of blood gamma glutamyl transferase and two showed mild elevations in total bilirubin. None of the participants showed detectable PRO 2000 in their blood after 14 days of product use.
  
  
  CONCLUSIONS
  0.5% PRO 2000 Gel appeared to be safe when used twice-daily by sexually active HIV-uninfected women from Pune, India. Although genitourinary discomfort and metrorrhagia were more common in the high-risk cohort, ongoing Phase II/IIb trial would provide data for generalization of this finding.
authors.affiliation: National AIDS Research Institute, India. sjoshi@nariindia.org
authors.forename: Joshi
authors.initials: J
authors.lastname: Smita
authors.forename: Dutta
authors.initials: D
authors.lastname: Soma
authors.forename: Bell
authors.initials: B
authors.lastname: Beverly
authors.forename: Profy
authors.initials: P
authors.lastname: Albert
authors.forename: Kuruc
authors.initials: K
authors.lastname: JoAnn
authors.forename: Gai
authors.initials: G
authors.lastname: Fang
authors.forename: Cianciola
authors.initials: C
authors.lastname: Missy
authors.forename: Soto-Torres
authors.initials: ST
authors.lastname: Lydia
authors.forename: Panchanadikar
authors.initials: P
authors.lastname: Anjali
authors.forename: Risbud
authors.initials: R
authors.lastname: Arun
authors.forename: Mehendale
authors.initials: M
authors.lastname: Sanjay
authors.forename: Reynolds
authors.initials: R
authors.lastname: Steven J