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
Study Design:
Arms and Assigned Interventions
DescriptionParticipants 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 DeliveryGel
ARMsExperimental
Official Code:
NCT00441298
Trial Sponsors:
Center for the AIDS Programme of Research in South Africa, CONRAD, FHI 360, USAID
Start Date
End Date
May 1, 2007
March 1, 2010
Enrollment:889
Age range:
18 Years ↔
40 Years
Population:Cisgender Women