Tenofovir vaginal microbicide gelTenofovir vaginal microbicide gel

Andy Gray

Consultant pharmacist

MissionMission

• To develop a female-controlled prevention option for HIV

2

The CAPRISA 004 study was conducted to establish whether the vaginal use of tenofovir gel is safe and whether it can

prevent male-to-female sexual transmission of HIV. Specifically, researchers conducted CAPRISA 004 to evaluate the safety and effectiveness of tenofovir in

comparison to a placebo gel (a matched gel with no active ingredient) in sexually active women at risk for human

immunodeficiency virus (HIV) infection in South Africa.

Initiation and processInitiation and process

• Investigator initiated - CAPRISA

• Externally funded but also locally supported by a state agency API donated by Gilead Sciences Trial medication and placebo manufactured by CONRAD Trial funded by USAID and LIFElab, supported by FHI Research infrastructure supported by NIH CIPRA and

Fogarty AITRP

StatusStatus

• Established proof of concept (phase IIb)• Royalty-free licence for manufacturing and supply to

Africa (TIA)• FDA opinion on need for confirmatory data• Consideration by an SA Medicines Control Council

expert committee