Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1% tenofovir · 1 trial · 1 indication
The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for \>120 days.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | 1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery |
| Control | ACTIVE_COMPARATOR | monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics |
| Name | Type | Description |
|---|---|---|
| 1% tenofovir gel | DRUG | Participants will be randomized to receive 1% tenofovir gel through either: * Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or * The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm). |
Inclusion Criteria: * Age 18 years and older * Women who previously participated in an ARV prevention study * Currently utilizing or agreeing to attend designated public sector family planning services * Able and willing to provide first person informed consent to be screened for, and to enroll in,...
1% tenofovir is an investigational topical gel being studied for HIV prevention. It is a small molecule developed by Gilead Sciences, Inc. (GILD) and is currently in Phase 2 clinical development. The gel is intended for use in women, as the completed trial enrolled female participants.
1% tenofovir is a small molecule that targets HIV. It is formulated as a 1% gel for topical application. The drug is being investigated for its effectiveness in preventing HIV infection, with a completed Phase 2 trial that enrolled 372 female participants in South Africa.
1% tenofovir is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. The drug is a small molecule in Phase 2 clinical development for HIV prevention.
1% tenofovir is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under investigation for HIV prevention.
1% tenofovir has one completed Phase 2 trial, NCT01691768, titled 'Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services.' The trial enrolled 372 female participants aged 18 years and older in South Africa and was active-controlled, though not double-blinded.
1% tenofovir is a specific formulation of tenofovir, a small molecule antiviral. The '1%' refers to the concentration of tenofovir in a topical gel. This formulation is being studied for HIV prevention, distinct from oral tenofovir products.