CAPRISA 004
On July 19, positive results were announced
from the CAPRISA 004 Phase IIb microbicide
trial of 1% tenofovir gel, which was tested in
889 South African women. Overall, there were 39
percent fewer infections among women who
received 1% tenfovir gel compared to women who
received the placebo gel. For more information,
click through the links below.
CAPRISA 004 is a Phase IIb, two-arm, double-blind, randomized, controlled microbicide trial that compared the effectiveness of a 1% tenofovir gel with a placebo gel for the prevention of HIV infection in women. Nearly 900 HIV-negative, sexually active women between the ages of 18 to 40 years were enrolled at two research sites: Durban and Vulindlela, located in KwaZulu-Natal, South Africa.
The first participant was enrolled on 23 May 2007, and results from the trial were announced at the International AIDS Conference in Vienna. The data was officially presented (and published in Science) on Tuesday, July 20 at 1pm CET (8am ET) at a special session, “Safety and effectiveness of 1% Tenofovir Vaginal Microbicide Gel in South African Women: Results of the CAPRISA 004 Trial”. This session is available by webcast at the Kaiser Family Foundation website.
Essential readings and materials:
Webcasts and slides
Peer-reviewed publications
AVAC publications
Additional Background
CAPRISA 004 is a Phase IIb, two-arm, double-blind, randomized, controlled microbicide trial that compared the effectiveness of a 1% tenofovir gel with a placebo gel for the prevention of HIV infection in women. Nearly 900 HIV-negative, sexually active women between the ages of 18 to 40 years were enrolled at two research sites: Durban and Vulindlela, located in KwaZulu-Natal, South Africa.
The first participant was enrolled on 23 May 2007, and results from the trial were announced at the International AIDS Conference in Vienna. The data was officially presented (and published in Science) on Tuesday, July 20 at 1pm CET (8am ET) at a special session, “Safety and effectiveness of 1% Tenofovir Vaginal Microbicide Gel in South African Women: Results of the CAPRISA 004 Trial”. This session is available by webcast at the Kaiser Family Foundation website.
Essential readings and materials:
Webcasts and slides
- Webcast of CAPRISA 004 results presented at AIDS 2010
- Civil
Society Feedback: Questions, concerns and
issues around CAPRISA 004 and next steps,
M. Chatani and N. Eland at WHO/UNAIDS
Consultation, August 25-26
Peer-reviewed publications
- Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women, data published in Science
AVAC publications
- A Cascade of Hope and Questions a four-part series
- Volume
2: Understanding the results of CAPRISA 004
(August 2010)
- Volume
1: Anticipating results of ARV-based HIV
prevention trials (July
2010)
- Press release from AVAC
Additional Background
- Global Campaign for Microbicides' telebriefing for advocates to discuss CAPRISA 004 results (download the presentation)