October 26, 2011

CONRAD Submits IND for Tenofovir 1% Gel for HSV-2 Prevention


CONRAD has submitted an Investigational New Drug Application (IND) for tenofovir 1% gel for the indications of HSV-2 prevention and management of HSV-2 events.  The new IND application details the first the first proposed study protocol in the management of genital HSV-2 shedding. 

The Phase IIa study will be a randomized, double-blinded, placebo-controlled clinical trial conducted at the University of Washington.  The crossover study design entails enrolling 66 women with documented HSV-2 who will first participate in a run-in phase with twice daily genital swabbing for HSV-2 detection and quantification.  Following four weeks of data collection, the women will be randomised (2:2:1) to one of three groups: 1) daily oral tenofovir (Viread) + vaginal placebo gel, 2) daily placebo oral + vaginal tenofovir 1% gel, or 3) daily placebo oral + vaginal placebo gel.  Participants will begin treatment and swap the genital region twice daily for five weeks. 

The CAPRISA 004 study found that in addition to reducing HIV infection by 39%, tenofovir gel was 51% effective in preventing genital herpes infections in the women participating in the trial. Out of the 434 women who tested negative for herpes at the start of the trial, 29 became infected in the tenofovir group and 58 became infected in the placebo group. The reduced rates of HIV and herpes infections among the women who used the tenofovir gel were statistically significant. 

Women with genital herpes are more likely to become infected with HIV, therefore the additional protection of tenofovir gel against herpes creates a second mechanism whereby the gel may have a bigger impact in preventing HIV.

Supporting data from the CAPRISA 004 study will be submitted, as well as plans outlining details to collect data on HSV-2 events in the VOICE and FACTS-001 studies. For more information, please contact Marianne Callahan at mcallahan@conrad.org.