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

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Abstract
Vaginal delivery of 200 mg or 25 mg 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 mg/ml. Mean dapivirine concentrations in vaginal and cervical tissues on day 7 were 0.3-0.7 mg/g in IPM001 and 1.5-3.5 mg/g in IPM008. Mean plasma concentrations of dapivirine were < 50 pg/ml. Dapivirine from both IVRs was successfully distributed throughout the lower genital tract at concentrations > 1000x the EC50 against wild-type HIV-1 (LAI) in MT4 cells suggesting that IVR delivery of microbicides is a viable option meriting further study.

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MLA
Romano, J et al. “Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring.” AIDS RESEARCH AND HUMAN RETROVIRUSES 25.5 (2009): 483–488. Print.
APA
Romano, J., Variano, B., Coplan, P., Van Roey, J., Douville, K., Rosenberg, Z., Temmerman, M., et al. (2009). Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring. AIDS RESEARCH AND HUMAN RETROVIRUSES, 25(5), 483–488.
Chicago author-date
Romano, J, B Variano, P Coplan, J Van Roey, K Douville, Z Rosenberg, Marleen Temmerman, et al. 2009. “Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring.” Aids Research and Human Retroviruses 25 (5): 483–488.
Chicago author-date (all authors)
Romano, J, B Variano, P Coplan, J Van Roey, K Douville, Z Rosenberg, Marleen Temmerman, Hans Verstraelen, Lucas Van Bortel, Steven Weyers, and M Mitchnick. 2009. “Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring.” Aids Research and Human Retroviruses 25 (5): 483–488.
Vancouver
1.
Romano J, Variano B, Coplan P, Van Roey J, Douville K, Rosenberg Z, et al. Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring. AIDS RESEARCH AND HUMAN RETROVIRUSES. 2009;25(5):483–8.
IEEE
[1]
J. Romano et al., “Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring,” AIDS RESEARCH AND HUMAN RETROVIRUSES, vol. 25, no. 5, pp. 483–488, 2009.
@article{689569,
  abstract     = {Vaginal delivery of 200 mg or 25 mg 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 mg/ml. Mean dapivirine concentrations in vaginal and cervical tissues on day 7 were 0.3-0.7 mg/g in IPM001 and 1.5-3.5 mg/g in IPM008. Mean plasma concentrations of dapivirine were < 50 pg/ml. Dapivirine from both IVRs was successfully distributed throughout the lower genital tract at concentrations > 1000x the EC50 against wild-type HIV-1 (LAI) in MT4 cells suggesting that IVR delivery of microbicides is a viable option meriting further study.},
  author       = {Romano, J and Variano, B and Coplan, P and Van Roey, J and Douville, K and Rosenberg, Z and Temmerman, Marleen and Verstraelen, Hans and Van Bortel, Lucas and Weyers, Steven and Mitchnick, M},
  issn         = {0889-2229},
  journal      = {AIDS RESEARCH AND HUMAN RETROVIRUSES},
  language     = {eng},
  number       = {5},
  pages        = {483--488},
  title        = {Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring},
  url          = {http://dx.doi.org/10.1089/aid.2008.0184},
  volume       = {25},
  year         = {2009},
}

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