Safety and Availability of Dapivirine (TMC120) Delivered from an Intravaginal Ring
Authors & affiliation
J Romano, B Variano, P Coplan, J Van Roey, K Douville, Z Rosenberg, Marleen Temmerman, Hans Verstraelen, Lucas Van Bortel, Steven Weyers, M Mitchnick
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.
Publication date:
2009
Staff members:
Link to publication
Attachments
aid.2008.0184.pdf (restricted)Related publications
Olivier Degomme, Emilie Peeters, Hedwig Deconinck, Alban Ylli, Albana Fico, Gentiana Qirjako, Dorina Ttocaj, Sara De Meyer, Kristien Michielsen, Anna Page, Wina Baeha, Kristi Praptiwi, Miranda van Reeuwijk, Beatriz Manuel, Elin C. Larsson, Carmen Ortiz, Bernardo Vega, Monserrath Jerves, Simukai Shamu, Annemiek Seeuws, Anna Galle, Anne Nobels, Ines Keygnaert, Hazel Barrett, Nina Van Eekert, Tammary Esho, Els Leye, Carles Pericas Escale, Samuel Thuo Kimani, Sofie Thielemans, Dara De Schutter, Remi Moerkerke, Louis De Backer, Viola N. Nyakato, Elizabeth Kemigisha, Wei Hong Zhang, Marleen Temmerman, Lina Hu, Shangchun Wu, Kaiyan Pei, Charlotte Neves de Oliveira, Argyro Chatzinikolaou, Eva Lievens
2022 Barriers and facilitators to cervical cancer screening among under- and neverscreened women in Belgium : a qualitative study on community and healthcare providers’ perspectiveBo Verberckmoes, Elien De Paepe, Janne De Vestele, Heleen Vermandere, Ines Keygnaert, Olivier Degomme
2022 Inhoudelijk eindrapport Opleiding seksueel geweld voor de Family Justice Centers & Ketenaanpak Intrafamiliaal GeweldSaar Baert, Lisa Fomenko, Nele Vaerewijck, Lotte De Schrijver, An-Sofie Van Parys, Ines Keygnaert