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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05140954 | The Women TAF-FTC Benchmark Study | PHASE2 | COMPLETED | 54 | — | — | Mar 28, 2023 | Dec 19, 2023 | Oct 27, 2025 | 1 | Kenya |
The frequency of graded adverse events by arm, including emergent HIV infection during the study period.
TFV-DP and FTC-TP concentrations observed in dried blood spots (DBS) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
Fitted steady-state TFV-DP concentrations after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.
| Arm | Type | Description |
|---|---|---|
| Perfect Adherence | EXPERIMENTAL | Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week). |
| Moderate Adherence | EXPERIMENTAL | Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week |
| Poor Adherence | EXPERIMENTAL | Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week |
| Name | Type | Description |
|---|---|---|
| co-formulated 25mg TAF/ 200mg FTC | DRUG | Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 25 mg TAF/ 200mg FTC |
Inclusion Criteria: * Age ≥18 and ≤30 years old * Willing to undergo urine pregnancy tests * Has understood the information provided and has provided written informed consent before any study-related procedures are performed. * HIV uninfected based on negative HIV rapid tests, according to Kenyan n...