Article

A randomized, double-blind, placebo-controlled Phase II extended safety study of two Invisible Condom (R) formulations in Cameroonian women

Laboratoire de Santé Hygiène Mobile, Ministry of Public Health and Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.
Contraception (Impact Factor: 2.34). 01/2010; 81(1):79-85. DOI: 10.1016/j.contraception.2009.07.002
Source: PubMed

ABSTRACT

Invisible Condom gel formulations being developed as microbicides to prevent the sexual transmission of HIV are advancing through the phases of clinical trials. The objectives of this study were to evaluate, after 8 weeks of vaginal application, the extended safety and acceptability of two Invisible Condom vaginal gel formulations: (i) the polymer alone and (ii) the polymer containing sodium lauryl sulfate (SLS) compared to placebo.
This study is a randomized, doubled-blind, placebo-controlled Phase II extended safety study in healthy sexually active women from Yaoundé, Cameroon. Women were randomized into three gel arms: (i) placebo, (ii) polymer alone and (iii) polymer/SLS. Women applied gel intravaginally twice daily for 8 weeks.
A total of 194 sexually active women applied placebo (n=41), polymer alone (n=76) and polymer/SLS (n=77). Invisible Condom gel formulations were well tolerated with no reported serious adverse events. The majority of reported adverse events were mild or moderate and mostly similar in all three arms, except for pelvic pain that was 10% higher in the polymer and polymer/SLS arms compared to placebo. Colposcopy showed neither genital ulceration nor mucosal lesions. Nugent score, H(2)O(2)-producing lactobacilli and vaginal pH were not affected by the study products. The gel formulations and applicator were generally acceptable and comfortable.
This extended safety study showed that the Invisible Condom gel formulations and applicator were well tolerated and acceptable when applied intravaginally twice daily for 8 weeks. Thus, further phases of clinical development of Invisible Condom as a potential microbicide to prevent sexual transmission of HIV are warranted.

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    • "A: μ 30 y Invisible Condom ® formulations and applicator were well-tolerated when applied intravaginally bid for 2 w 70–86% compliance; however, only 20% of gel applications coincided with sex[23]Cellulose[Cotonou, Benin]gel use: 63% AWMP, 94% AWOP (last 7 d);[Kampala, Uganda]gel use: 60% AWMP, 85% AWOP (last 7 d);[Durban, South Africa]gel use: 91% AWMP, 95% AWOP (last 7 d);[Chennai, India]gel use: 38% AWMP, 91% AWOP (last 7 d);[24][25](Continued)[Isipingo, Durban, KwaZulu-Natal]Gel: μ 92% at LS (SELF); CLS: μ 58% (SELF); μ 55% covered acts[26][Masaka, Uganda]A: μ 32 y; E: 2% ≥ secondary; NP: 0% >1 partner (last 1 w); CF: median 1 APW; AI: <0.5% (last 4 w); CLS: 70%; FP: 27%;[Mwanza, Tanzania]A: μ 30 y; E: 5% ≥ secondary; NP: 3% >1 partner (last 1 w); CF: median 1 APW; AI: <0.5% (last 4 w); CLS: 33%; FP: 50%;[CF: median 2 APW; AI: 46% (ever); CLS: 61%; FP: 89%;[Kamwala, Zambia]A: μ 23 y; E: 9% ≥ secondary; NP: 3% >1; CF: median 3 APW; AI: 3% (ever); CLS: 77%; FP: 98%;[Chitungwiza, Zimbabwe]A: μ 26 y; E: 29% ≥ secondary; NP: 3% >1; CF: median 5 APW; AI: 1% (ever); CLS: 87%; F: 99%[Harare, Zimbabwe][31](Continued) "

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    • "Sodium lauryl sulfate (Invisible Condom; Université Laval, Quebec, Canada), another surfactant has been shown to disrupt both nonenveloped and enveloped viruses.37 A randomized, double blind, placebo-controlled Phase II study in Cameroonian women revealed that the Invisible Condom gel formulation was well tolerated and acceptable.38 Further phases of clinical development of Invisible Condom as a potential micro-bicide to prevent sexual transmission of HIV are awaited. "
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    ABSTRACT: Microbicides, primarily used as topical pre-exposure prophylaxis, have been proposed to prevent sexual transmission of HIV. This review covers the trends and challenges in the development of safe and effective microbicides to prevent sexual transmission of HIV Initial phases of microbicide development used such surfactants as nonoxynol-9 (N-9), C13G, and sodium lauryl sulfate, aiming to inactivate the virus. Clinical trials of microbicides based on N-9 and C31G failed to inhibit sexual transmission of HIV. On the contrary, N-9 enhanced susceptibility to sexual transmission of HIV-1. Subsequently, microbicides based on polyanions and a variety of other compounds that inhibit the binding, fusion, or entry of virus to the host cells were evaluated for their efficacy in different clinical setups. Most of these trials failed to show either safety or efficacy for prevention of HIV transmission. The next phase of microbicide development involved antiretroviral drugs. Microbicide in the form of 1% tenofovir vaginal gel when tested in a Phase IIb trial (CAPRISA 004) in a coitally dependent manner revealed that tenofovir gel users were 39% less likely to become HIV-infected compared to placebo control. However, in another trial (VOICE MTN 003), tenofovir gel used once daily in a coitally independent mode failed to show any efficacy to prevent HIV infection. Tenofovir gel is currently in a Phase III safety and efficacy trial in South Africa (FACTS 001) employing a coitally dependent dosing regimen. Further, long-acting microbicide-delivery systems (vaginal ring) for slow release of such antiretroviral drugs as dapivirine are also undergoing clinical trials. Discovering new markers as correlates of protective efficacy, novel long-acting delivery systems with improved adherence in the use of microbicides, discovering new compounds effective against a broad spectrum of HIV strains, developing multipurpose technologies incorporating additional features of efficacy against other sexually transmitted infections, and contraception will help in moving the field of microbicide development forward.
    Full-text · Article · Oct 2013 · HIV/AIDS - Research and Palliative Care
    • "Sodium lauryl sulphate (Invisible Condom, Universite Laval, Quebec, Canada) is another surfactant compound that has been shown to disrupt both non-enveloped and enveloped viruses40. The extended safety study showed that the Invisible Condom gel formulations were well tolerated and acceptable and hence further phases of its clinical development as a potential microbicide to prevent sexual transmission of HIV are warranted41. "
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    ABSTRACT: Human immunodeficiency virus (HIV), causative agent of acquired immunodeficiency syndrome (AIDS), is a global health concern. To control its transmission, safe sex has been proposed as one of the strategies. Microbicides- intravaginal/intrarectal topical formulations of anti-HIV agents have also been proposed to prevent HIV transmission. Microbicides would provide protection by directly inactivating HIV or preventing the attachment, entry or replication of HIV in susceptible target cells as well as their dissemination from target cells present in semen or the host cells lining the vaginal/rectal wall to other migratory cells. Microbicides must be safe, effective following vaginal or rectal administration, and should cause minimal or no genital symptoms or inflammations following long-term repeated usage. However, a safe and efficacious anti-HIV microbicide is not yet available despite the fact that more than 60 candidate agents have been identified to have in vitro activity against HIV, several of which have advanced to clinical testing. Nonetheless, proof-of-concept of microbicides has been established based on the results of recent CAPRISA 004 clinical trials. In this article, the trends and challenges in the development of effective and safe microbicides to combat HIV transmission are reviewed.
    No preview · Article · Dec 2011 · The Indian Journal of Medical Research
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