Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring.

From:
Foreign, Commonwealth & Development Office
Published
1 January 2009
Country:
Belgium
Document Type:
Journal Article
Theme:
Health
First published:
1 January 2009
Authors:
Romano, J., Mitchnick, M., Rosenberg, Z., Douville, K. and Coplan, P.
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Variano, B., Temmerman, M., Weyers, S., Verstraelen, H., van Roey, J., and Bortel, L.van

Abstract

Vaginal delivery of 200鈥塵g or 25鈥塵g dapivirine from intravaginal rings (IVRs) was evaluated over a 7-day period in two phase 1 safety trials (IPM001 and IPM008, respectively) in a total of 25 healthy women 19 to 46 years of age. The IVR was generally safe and well tolerated with similar adverse events observed in the placebo and dapivirine groups. Across both studies, dapivirine concentrations in vaginal fluids measured at the introitus, cervix, and ring area were within the mean range of 0.7-7.1鈥壩糶/ml. Mean dapivirine concentrations in vaginal and cervical tissues on day 7 were 0.3-0.7鈥壩糶/g in IPM001 and 1.5-3.5鈥壩糶/g in IPM008. Mean plasma concentrations of dapivirine were 1000 x the EC<sub>50</sub> against wild-type HIV-1 (LAI) in MT4 cells suggesting that IVR delivery of microbicides is a viable option meriting further study.

Citation

Romano, J.; Variano, B.; Coplan, P.; Douville, K.; Rosenberg, Z.; Temmerman, M.; Verstraelen, H.; Weyers, S.; Mitchnick, M.; van Roey, J.; Bortel, L.van. Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring. AIDS Research and Human Retroviruses (2009) 25 (5) 483-488. [DOI: 10.1089/aid.2008.0184]

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Published 1 January 2009
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