Clinical Trials Resource Center

New Medical Therapies™

Sexually Transmitted Diseases (STDs)

July 26, 2010

Results were reported from a phase IIb trial evaluating Gileads tenofovir gel as a microbicide against HIV and genital herpes. This trial, CAPRISA 004 (Centre for the AIDS Programme of Research in South Africa), enrolled 889 South African women who were 18 to 40 years of age, HIV-negative, sexually active, and at high risk of becoming infected with HIV. The subjects were asked to vaginally insert a first dose of tenofovir gel no more than 12 hours before having sex and to insert a second dose no more than 12 hours after having sex. No more than two doses of gel were used in a 24-hour period. The treatment period was 12 to 18 months. The gel was found to be 39% effective in reducing the risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections. The efficacy of tenofovir was greater with increased usage. The women who used the gel more than 80% of the time had a 54% reduction in HIV infections, whereas those who used the gel less than half the time had a 28% reduction in HIV infections.

September 11, 2006

Nventa released positive results from a phase II trial of HspE7, a therapeutic vaccine, for the treatment of internal and external anal genital warts. This single-arm trial enrolled 30 HIV-negative men, all of who had internal warts and 10 of who had external warts. Subjects received three monthly injections of HspE7 at 1500 mcg and followed for 48 weeks. Treatment was well tolerated with headache being the most commonly reported adverse event (27%). Efficacy data revealed that at week 24, 11% of the subjects had complete response, defined as absence of warts and 67% had partial response. At 48 weeks 33% had complete response while 48% had partial response and a 71% mean decrease in volume of the genital warts was observed. Of the subjects with external genital warts, 70% had complete response. Based on these results, Nventa plans to move HspE7 into future trials.

October 14, 2002

AuRx reported positive results for a phase I/II trial for the treatment of genital herpes. The HSV-2 theracine vaccine produced no adverse events and the side effects were similar to that of the placebo. The vaccine reduced the number of genital herpes cases three fold versus the previous year. In 37.5% of subjects the recurrent episodes of HSV-2 were completely prevented. Of subjects vaccinated, 50% had fewer recurrences and 45% had fewer illness days than the placebo.

August 19, 2002

Results of two international studies involving over 700 subjects indicated that imiquimod cream 5% is effective in treating women with external genital warts. 75% of subjects treated with imiquimod experienced complete clearance of their warts. Although 15% of subjects had warts return six months after finishing treatment, re-application of the product for an additional 16 weeks cleared the warts in 75% of those subjects. Imiquimod is manufactured by 3M Pharmaceuticals.

March 11, 2002

Phase IIa trial results indicate that TMC125 produces antiviral activity in HIV subjects infected with NNRTI-resistant virus and failing NNRTI therapy. In this open-label trial, 16 subjects received TMC125 for one week. The median reduction in viral load was 87% after seven days of treatment, with viral load reductions ranging from 37% to 98%. No genotypic or phenotypic evidence of the development of resistance was observed during the trial. TMC125 is being developed by Tibotec-Virco.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.