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Tenofovir vaginal microbicide gel

Tenofovir vaginal microbicide gel. Andy Gray Consultant pharmacist. Mission. To develop a female-controlled prevention option for HIV.

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Tenofovir vaginal microbicide gel

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  1. Tenofovir vaginal microbicide gel Andy Gray Consultant pharmacist

  2. Mission • To develop a female-controlled prevention option for HIV 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.

  3. Initiation 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

  4. Status • 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

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