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Also known as 1% tenofovir gel
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 a topical gel being studied for HIV prevention in women. It is applied vaginally and was evaluated in a Phase 2 trial in South Africa that provided the gel through family planning services. The product is investigational and has not been approved for use.
1% tenofovir is developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is the company associated with the tenofovir gel program.
1% tenofovir is in Phase 2 development. The program has one completed Phase 2 trial and no active trials. It is investigational and has not been approved by the FDA.
1% tenofovir was studied in NCT01691768, a completed Phase 2 trial titled Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services. The trial enrolled 372 women aged 18 and older in South Africa and was active-controlled and randomized.
Yes, 1% tenofovir and 1% tenofovir gel refer to the same product. The gel formulation is the form studied in the Phase 2 HIV prevention trial conducted in South Africa.