Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for the AIDS Programme of Research in South Africa
• Collaborators: CONRAD; FHI 360; United States Agency for International Development (USAID)
• Treatments: Anti-Infective Agents; Tenofovir

Criteria

Inclusion Criteria:

• Age 18-40 years (inclusive)

• Able and willing to provide written informed consent to be screened for, and to enrol in, the study.

• Able and willing to provide adequate locator information for study retention purposes.

• Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.

• HIV negative on testing performed by study staff within 30 days of enrolment.

• Have a negative pregnancy test which was performed by study staff within 21 days of enrolment

• Agree to use a non-barrier form of contraceptive

• Agree to adhere to study visits and procedures

Exclusion Criteria:

• History of adverse reaction to latex.

• Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):

• To travel away from the study site for more than 30 consecutive days.

• To relocate away from the study site.

• To become pregnant

• To enrol in any other study of an investigational product or behaviour modification related to HIV prevention.

• Has a creatinine clearance <50ml/min, as estimated using the method of Cockcroft and Gault(33).

• Has active Hepatitis B infection (since January 2009)

• Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.

• Has in the past year participated in any research related to any vaginally applied product/s.

• Has current STI symptoms and/or other reproductive tract infection requiring treatment, as assessed by study staff. Otherwise eligible participants diagnosed during screening with infection(s) requiring treatment may be enrolled provided that treatment has commenced.

• Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.