CAPRISA 004

Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women.

Conducted in South Africa this phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel was an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants were provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants were asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants received HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.

Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures:
•Comparison of HIV incidence rates in 2 arms (tenofovir vs placebo) [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]


Secondary Outcome Measures:
•To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]

•To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial. [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]

•To assess tenofovir resistance in HIV seroconvertors in the trial [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]

•To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]

•To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]


Enrollment: 900
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Results are anticipated in July 2010 and their outcome has a bearing on ongoing trials in Zimbabwe.

Source: http://clinicaltrials.gov