BufferGel Phase I Trials in Women
Two clinical trials have been completed to assess the safety of BufferGel used vaginally by women of reproductive age who were HIV-negative, and either sexually-active and monogamous with low risk for HIV acquisition, or sexually abstinent. One trial was conducted in the U.S.; the other was conducted at four separate international sites in India, Thailand, Malawi and Zimbabwe.
In the U.S. study, BufferGel was evaluated by 27 women after vaginal application once daily for fourteen days. Women underwent colposcopy twice prior to exposure to BufferGel and again after 2 weeks of use. Participants were then given the option of using the product twice a day. Endpoints included the effect of BufferGel on the vulvar and cervicovaginal mucosa and tolerability. BufferGel showed minimal toxicity and was well tolerated and accepted. Reported adverse events were nearly all categorized as mild. The majority of the participants in the study said they would use the product if it were commercially available.
In the international study, BufferGel was tested in a high-dose tolerance trial. BufferGel was evaluated by 98 women for vaginal use twice daily. Compliance was 93%. BufferGel was found to be safe and well tolerated by the cervicovaginal epithelium. The study showed that the prevalence of BV was significantly reduced during BufferGel use.
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BufferGel Phase I Trials in Men
Two Phase I trials have assessed the safety of BufferGel exposure to men. These trials included both circumcised, and uncircumcised men, and HIV negative and HIV positive men. BufferGel was found safe and acceptable with intensive exposure (nightly application for seven days).
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Phase II/III Clinical Trial for Contraceptive Efficacy
Two pivotal Phase II/III clinical trials of BufferGel® plus diaphragm as a contraceptive were recently completed in more than 1200 women, funded by the National Institutes of Health (NIH, NICHD Contraceptive Branch).
- The first and larger trial was a randomized comparative study designed to test the non-inferiority of BufferGel to a marketed comparison spermicide, Gynol II, both products used with a diaphragm. The trial found BufferGel to be non-inferior to Gynol II; the point estimates of pregnancy rates were lower for BufferGel than for Gynol II.
- The second, an open label trial, confirmed BufferGel’s effectiveness.
Thus, BufferGel with a diaphragm is a safe and effective contraceptive. The results of this trial are reported in: Barnhart et al, “Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: randomized controlled trial” Obstet Gynecol. 2007 Sep;110(3):577-86. .These successful trials represent a major milestone for ReProtect, and constitute the pivotal efficacy trials needed in preparation for New Drug Application (NDA) to the US FDA.
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Phase II/IIb Clinical Trial for HIV Prevention
BufferGel was chosen by the National Institutes of Health (NIH) to be evaluated for HIV prevention effectiveness in a Phase II/IIb clinical trial, initiated in February 2005.
Efficacy of BufferGel Used Vaginally to Prevent HIV/AIDS Transmission (HPTN 035)
- Performed by the NIH (National Institute on Allergy and Infectious Diseases), the HIV Prevention Trial Network (HPTN), and Family Health International (FHI).
- The study is a Phase II/IIb trial that will enroll approximately 3,100 women. The trial includes sites in 5 countries: Zimbabwe, Malawi, Zambia, South Africa, and the USA.
- Four-arm trial comparing BufferGel, PRO2000 (Indevus, Inc.), a placebo gel, and no gel. Women in all arms of the trial will be counseled to use condoms, and condoms will be provided to all participants.
- The trial will also test the efficacy of BufferGel for the prevention of bacterial vaginosis, herpes virus infection, and other STDs.
- Results of this trial are expected to be announced in February, 2009.
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Duet™ Phase I Trial
BufferGel-Duet was recently studied in a Phase I Trial, funded by CONRAD and USAID, to assess its safety and efficacy. Thirty couples in the US and the Dominican Republic used BufferGel-Duet. Twenty-nine of the thirty couples (97%) used the device successfully during two episodes of intercourse, indicating that as intended, the device is indeed one-size-fits-most. The device was judged safe and acceptable.
The results are reported in Ballagh et al, “A Phase I study of the functional performance, safety and acceptability of the BufferGel Duet.”
Contraception. 2008 Feb;77(2):130-7. Epub 2007 Dec 27.
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