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CAPRISA 004

Status
Completed
Phase
IIb
Principal Investigator(s)
Salim S Abdool karim; Quarraisha Abdool Karim
Objective

This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.

Prevention Option(s)
Microbicides
Arms and Assigned Interventions
Description
Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Mode of Delivery
Gel
ARMs
Placebo Comparator
Similar Trials
Trial Sponsors
Centre for the AIDS Programme of Research in South Africa; FHI 360; United States Agency for International Development (USAID); CONRAD
May 2007
March 2010
Enrollment
889
18
Years
40
Years
Population
Women
Sites

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal
South Africa

CAPRISA Vulindlela Clinical Research Site

Pietermaritzburg, KwaZulu-Natal
South Africa