Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00441298 | Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV | PHASE2 | COMPLETED | 889 | — | — | May 1, 2007 | Mar 1, 2010 | Feb 1, 2016 | 2 | South Africa |
The effectiveness of tenofovir against HIV infection will be measured by comparing the incidence of HIV in the tenofovir arm with that in the placebo arm
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Tenofovir gel (a reverse transcriptase inhibitor) |
| 2 | PLACEBO_COMPARATOR | Universal HEC placebo |
| Name | Type | Description |
|---|---|---|
| Tenofovir gel | DRUG | 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. |
| Placebo (Universal HEC placebo) | DRUG | 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. |
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 intercou...