Global Work on Microbicide Development

CONRAD provided supplies of the antiretroviral tenofovir gel for the CAPRISA 004 Phase IIb clinical trial for HIV prevention in South Africa, which showed tenofovir gel to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex. CONRAD will provide tenofovir gel for upcoming international trials to confirm the CAPRISA results. CONRAD is also supplying tenofovir gel for the Microbicide Trials Network (MTN) Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial, which is comparing oral tenofovir and tenofovir gel for the prevention of HIV in Uganda, South Africa, Zambia, Zimbabwe and Malawi.

Preclinical microbicide development, including screening and identification of promising compounds, development of animal models, bioanalytical method development and validation, and product formulation is ongoing by investigators, collaborators and contractors in Germany, Northern Ireland, England, Switzerland, Scotland and New Zealand.

A multi-site clinical trial to obtain data on the effects of contraceptive methods on the persistence of tenofovir within the mucosa and changes in markers of safety following vaginal use of 1% tenofovir gel will include a site in the Dominican Republic.

CONRAD is collaborating with the Indian Council of Medical Research to identify potential high HIV incidence sites in India capable of participating in effectiveness trials of HIV prevention technologies.

While the Phase III trial of cellulose sulfate for HIV prevention—conducted in South Africa, Uganda and India—concluded early due to lack of efficacy, the lessons learned from this trial and from subsequent studies of cellulose sulfate will be used to inform the development of new microbicide candidates.

Learn more about CONRAD’s global efforts on contraceptive development here.