Approval Probability
TA Base Rate
Adjusted LOA
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Tenofovir · 1 trial · 1 indication
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...
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Tenofovir is a small molecule being studied for the prevention of HIV Infections. It is being developed as a candidate vaginal microbicide for HIV prevention. The drug is currently in Phase 2 clinical development and is not yet approved for this use.
Tenofovir is a nucleotide reverse transcriptase inhibitor that works by blocking the activity of reverse transcriptase, an enzyme HIV needs to replicate. This mechanism is being evaluated in a Phase 2 trial for HIV prevention.
Tenofovir is being developed by United Therapeutics Corporation, which trades under the ticker UTHR. The company is conducting clinical trials to evaluate the drug as a vaginal microbicide for HIV prevention.
Tenofovir is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and no active trials are currently listed.
Tenofovir has one completed Phase 2 trial, NCT00441298, titled 'Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV'. This randomized, double-blind, placebo-controlled trial enrolled 889 female participants in South Africa.
Tenofovir is the active ingredient in Viread, a medication used to treat HIV and hepatitis B. In this context, it is being studied as a vaginal microbicide for HIV prevention, which is a different formulation and use.