First participant enrolled in CAP008 tenofovir gel implementation study
Today, the Centre for the AIDS Programme of Research in South Africa (CAPRISA) enrolled its first participant in the CAPRISA 008 tenofovir gel implementation study. CAPRISA 008 will provide CAPRISA 004 trial participants with post-trial access to tenofovir gel while assessing the feasibility of providing tenofovir gel through family planning services. This implementation study follows the landmark CAPRISA 004 trial announced in 2010, which provided proof-of-concept that an antiretroviral in a gel formulation (microbicide) can reduce male-to-female transmission of HIV, providing new hope for the fight against HIV/AIDS.
The implementation study is being conducted by CAPRISA and funded by United States Agency for International Development (USAID) through CONRAD, the South African Department of Science and Technology through the Technology Innovation Agency [TIA] and MACAIDS Fund through the Tides Foundation
CAPRISA 008 is an open-label randomized controlled trial to assess the implementation, effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa. If successful, it will open the way to more rapid access to microbicides following licensure.
FACTS 001, is a confirmatory study to CAPRISA 004 currently underway in several sites across South Africa. FACTS 001 is expected to report its results in mid to late 2014. If it confirms the CAPRISA 004 trial findings it could support licensure of tenofovir gel for HIV prevention. Hence, the next 2-3 years are a critical window of opportunity to prepare for and devise effective strategies for the future government policy and implementation of tenofovir gel provision through the public health system.
Approximately 700 consenting, sexually active, HIV-uninfected women from KwaZulu Natal will take part in CAPRISA 008. The women will receive tenofovir gel through either family planning services with 2-3 monthly provision and monitoring, or through the CAPRISA research clinics with monthly provision and monitoring of tenofovir gel (control arm). The CAPRISA 004 BAT 24 dosing strategy will be used wherein the first dose of tenofovir gel in inserted within 12 hours before anticipated intercourse and a second dose as soon as possible but within 12 hours after intercourse, with a maximum of two doses of gel in a 24-hour period.
Despite the availability of a number of proven HIV prevention option including male and female condoms, safer sex education, medical male circumcision and ART treatment for HIV-infected individuals, young women who bear the highest burden of HIV infection and who are unable to negotiate these prevention options with their sexual partner have no options to reduce their risk of HIV acquisition. Tenofovir gel is a promising new HIV-prevention technology that women can use without the need to seek her partner’s permission.