Efficacy and Action of the Dapivirine Vaginal Ring as Understood by Women Participating in an Open Label Extension Study.

The concept of efficacy, and how HIV prevention products biologically work can be complex. We report on women's interpretation of efficacy of the dapivirine vaginal ring and how they understood it to work to prevent HIV during the MTN-025/HOPE study through data collected from individual in-depth interviews. Ten women at each of the 6 HOPE research sites in Lilongwe, Malawi; Durban (2 sites) and Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza, Zimbabwe, were enrolled (n = 60). Despite its partial efficacy, women trusted the ring to prevent HIV even when condoms were not used. The action of the ring was understood by most, however, there were misunderstandings around how quickly or slowly protection was offered when the ring was inserted or removed. Counselling sessions adapted to address partial efficacy, a multi-layered HIV prevention plan and how study products work could alleviate inconsistent adherence and diminished protection and further support women in receiving the best protection from their HIV prevention product of choice.

Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India.

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. CONCLUSION: 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.