At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Pharmacokinetics of TAF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women
In Brief
A Phase 2 clinical trial evaluating co-formulated 25mg TAF/ 200mg FTC for HIV Infections. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure prophylaxis (PrEP) therapy with tenofovir alafenamide-emtricitabine (TAF-FTC). Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 18 weeks.These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.
Study Details
Timeline
Arms & Interventions
Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week
Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week
Interventions
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