Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
co-formulated TAF/ FTC · 1 trial · 1 indication
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...
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Co-formulated TAF/FTC is an investigational small molecule combination of tenofovir alafenamide (TAF) and emtricitabine (FTC) being studied for the treatment of HIV Infections. It is currently in Phase 2 clinical development. The drug is being evaluated in a clinical trial in Kenya, specifically in a study called The Women TAF-FTC Benchmark Study.
Co-formulated TAF/FTC is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research on this combination therapy for HIV Infections, with the drug currently in Phase 2 development.
Co-formulated TAF/FTC is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of HIV Infections, with one completed Phase 2 clinical trial involving 54 participants.
Co-formulated TAF/FTC has been studied in one clinical trial, NCT05140954, titled "The Women TAF-FTC Benchmark Study." This was a Phase 2, controlled, randomized trial conducted in Kenya with 54 female participants aged 18 years and older. The trial has been completed and included healthy volunteers.
Co-formulated TAF/FTC refers to a fixed-dose combination of tenofovir alafenamide (TAF) and emtricitabine (FTC). The drug is being developed by Gilead Sciences for HIV Infections. It is currently in Phase 2 clinical trials, and the specific formulation is being evaluated for its safety and efficacy.