Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial

One Percent Tenofovir Applied Topically to Humanized BLT Mice and Used According to the CAPRISA 004 Experimental Design Demonstrates Partial Protection from Vaginal HIV Infection, Validating the BLT Model for Evaluation of New Microbicide Candidates

“…Our experimental approach for testing these six inhibitors was a single dose of the product administered prior to exposure rather than the two doses of drug administered within 24 h as used in CAPRISA 004 (1). This experimental design is based on the more standard single-dose administration prior to exposure (19,23,29,35,44,47). This approach is simpler, more cost-effective than multiple applications per sexual encounter and has been postulated to help increase adherence among women (51).…”

“…each sexual encounter" protocol has been the most common microbicide application protocol applied in clinical trials and animal model studies (19,23,29,35,38,44,47,50,52). The six additional candidate microbicides that we tested using this experimental design represent a broad spectrum of inhibitors with distinct mechanisms capable of blocking HIV infection at several different steps of the viral replication cycle from preentry to postbudding (Table 1).…”

Pharmacokinetic study to compare the absorption and tolerability of two doses of levonorgestrel following single vaginal administration of levonorgestrel in Carraguard® gel: a new formulation for “dual protection” contraception

“…It has been an aim of the microbicide field for over 20 years when overthe-counter (OTC) spermicides were shown to possess activity against STIs [19] and subsequently activity against HIV [20]. However, initial clinical studies evaluating OTC spermicides as potential microbicides had mixed results [21][22][23][24] and were eventually abandoned with the disappointing results from the COL-1492 study, showing that the OTC spermicide nonoxynol-9 (N-9) could be toxic to the vaginal tissue thereby increasing the risk of HIV infection [25]. There are other candidate microbicides currently in clinical trials that might demonstrate dual protection [26][27][28][29][30].…”

The Future of HIV Prevention: Prospects for an Effective Anti-HIV Microbicide

“…Aside from efficacy, of utmost importance is safety. This was made clear during clinical trials investigating the use of the spermicide nonoxynol-9 as an HIV microbicide, in which the incidence of seroconversions was higher in women who used nonoxynol-9 multiple times each day when compared with those receiving placebo [20]. Possible explanations for this finding include inflammatory cell recruitment to the genital tract and epithelial damage resulting from the local toxicity of nonoxynol-9 [20,21].…”

“…This was made clear during clinical trials investigating the use of the spermicide nonoxynol-9 as an HIV microbicide, in which the incidence of seroconversions was higher in women who used nonoxynol-9 multiple times each day when compared with those receiving placebo [20]. Possible explanations for this finding include inflammatory cell recruitment to the genital tract and epithelial damage resulting from the local toxicity of nonoxynol-9 [20,21]. Secondly, it is crucial that a microbicide is used correctly, so it must be easy to use, acceptable to the user, should not interfere with sexual intercourse, and should have an appropriate duration of action [22].…”