Headed by Salim Abdool Karim in association Ayesha Kharsany
The highest burden of HIV infection is in women younger than 30 years, making prevention interventions targeting adolescents and young women a high priority. Various sexual coupling patterns place young women at high risk, including partnering with older men who are more likely to be infected, multiple concurrent relationships, low marriage rates, low condom use rates, and limited skills in negotiating safer sex practices. Gender-based violence increases vulnerability, and poverty increases reliance on transactional sex for survival. Women are often unable to convince their male partners, especially husbands and regular partners, to use condoms.
Notwithstanding the greater vulnerability of women, current options to reduce acquisition of HIV infection remain limited for women. New technologies to prevent the sexual transmission of HIV in women are urgently needed. Even a partially effective microbicide could have a profound impact on the dynamics of HIV transmission. According to mathematical modelling, 2.5 million HIV infections could be averted over 3 years if a microbicide with 60% effectiveness was used in 73 low-income countries. Hence, CAPRISA is conducting research aimed at discovering a safe and effective microbicide.
CAPRISA 004 TENOFOVIR GEL TRIAL
The pivotal study in the CAPRISA Microbicide Research programme is the CAPRISA 004 Tenofovir Gel Trial, which is a phase IIb, two-arm, double-blind, randomized, controlled trial assessing the safety and effectiveness of 1% tenofovir gel, in 900 HIV-negative, sexually active women between the ages of 18 to 40 years. The trial is being conducted at two clinical research sites, Durban and Vulindlela, located in KwaZulu-Natal, South Africa. Results from this study were announced at the XVIIIth International AIDS Conference in Vienna on 20 July 2010.
The CAPRISA 004 Tenofovir Gel Trial presents a unique opportunity to conduct a range of ancillary clinical and laboratory studies on topical tenofovir to further advance the microbicide field. The TRAPS Program (Tenofovir gel Research for Advancing Prevention Science) has been established to address the following questions: 1) Does tenofovir abort HIV infection and initiate potentially protective host immunity?, 2) What tenofovir drug level correlates with protection against HIV and resistance? and 3) How does tenofovir alter natural HIV infection (including set point)? The CAPRISA 104 study, also an ancillary study in CAPRISA 004, is a case-control study to assess gel adherence in trial seroconvertors.
CAPRISA participates in several international microbicide activities including the Microbicide Trials Network, Quick Working Group and the Microbicide Development Strategy. New microbicide formulations are also being assessed for future studies.