OBJECTIVES: To evaluate once or twice daily vaginal exposure to 2 and 4% PRO 2000Gel, a naphthalene sulfonate polymer microbicide, in sexually active HIV-uninfected women to determine the highest tolerated frequency and concentration combination, and to assess this in sexually abstinent HIV-infected women. METHODS:Sixty three women from Providence, Philadelphia, Durban and Johannesburg were enrolled after being screened to exclude pre-existing illnesses and were instructed to use the product once or twice daily for 14 intermenstrual days. They underwent colposcopy prior to product use and after 14 days of product use, with a pelvic examination at day 7. RESULTS: The product was well tolerated, with no serious adverse events, even though 73% of the participants had at least one adverse experience: 82% of these were classified as mild, and over 90% of the findings and symptoms were localized to the genital tract. Women who used the 4% gel twice daily tended to have more adverse events than all the other groups. Three participants did not complete the study; one because of Herpes simplex virus cervicitis, the second because of epithelial disruption, and the third because she became pregnant. The remaining participants adhered to the study protocol and indicated that they would use the product if it were shown to be effective. CONCLUSIONS:PRO 2000Gel was safe and well tolerated in sexually active HIV-uninfected and sexually abstinent HIV-infected women, enabling the product to be considered for evaluation in efficacy trials.
RCT Entities:
OBJECTIVES: To evaluate once or twice daily vaginal exposure to 2 and 4% PRO 2000 Gel, a naphthalene sulfonate polymer microbicide, in sexually active HIV-uninfectedwomen to determine the highest tolerated frequency and concentration combination, and to assess this in sexually abstinent HIV-infectedwomen. METHODS: Sixty three women from Providence, Philadelphia, Durban and Johannesburg were enrolled after being screened to exclude pre-existing illnesses and were instructed to use the product once or twice daily for 14 intermenstrual days. They underwent colposcopy prior to product use and after 14 days of product use, with a pelvic examination at day 7. RESULTS: The product was well tolerated, with no serious adverse events, even though 73% of the participants had at least one adverse experience: 82% of these were classified as mild, and over 90% of the findings and symptoms were localized to the genital tract. Women who used the 4% gel twice daily tended to have more adverse events than all the other groups. Three participants did not complete the study; one because of Herpes simplex virus cervicitis, the second because of epithelial disruption, and the third because she became pregnant. The remaining participants adhered to the study protocol and indicated that they would use the product if it were shown to be effective. CONCLUSIONS:PRO 2000 Gel was safe and well tolerated in sexually active HIV-uninfected and sexually abstinent HIV-infectedwomen, enabling the product to be considered for evaluation in efficacy trials.
Authors: Youssef Gali; Olivier Delezay; Joachim Brouwers; Noura Addad; Patrick Augustijns; Thomas Bourlet; Hind Hamzeh-Cognasse; Kevin K Ariën; Bruno Pozzetto; Guido Vanham Journal: Antimicrob Agents Chemother Date: 2010-10-04 Impact factor: 5.191
Authors: Kathleen M Morrow; Joseph L Fava; Rochelle K Rosen; Sara Vargas; Candelaria Barroso; Anna L Christensen; Cynthia Woodsong; Lawrence Severy Journal: J Acquir Immune Defic Syndr Date: 2007-05-01 Impact factor: 3.731
Authors: Lin Li; Pengyuan Qiao; Jie Yang; Lu Lu; Suiyi Tan; Hong Lu; Xiujuan Zhang; Xi Chen; Shuguang Wu; Shibo Jiang; Shuwen Liu Journal: Retrovirology Date: 2010-04-26 Impact factor: 4.602