CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled / 72 target
Drug / intervention
co-formulated 300 mg TDF/ 200mg FTCdrug
Likely dose
co-formulated 300 mg TDF/ 200mg FTCfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05057858
NCT05057858Phase 2CompletedOn Track (1.4/mo)Completion was 20mo ago
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Pharmacology of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women

University of Washington·interventional·Posted Sep 27, 2021·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating co-formulated 300 mg TDF/ 200mg FTC for HIV Infections. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated with HIV protection in cisgender women. Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 16 weeks. The study will also investigate how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesKenya
CollaboratorsUniversity of Colorado, Denver, Kenya Medical Research Institute, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedSep 27, 2021
Enrollment StartApr 25, 2022
Primary CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.8 years ago

Arms & Interventions

Perfect Adherenceexperimental

Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).

Drug: co-formulated 300 mg TDF/ 200mg FTC
Moderate Adherenceexperimental

Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet 4 times per week (Monday, Tuesday, Thursday, Friday)

Drug: co-formulated 300 mg TDF/ 200mg FTC
Poor Adherenceexperimental

Cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC tablet twice per week(Monday and Tuesday)

Drug: co-formulated 300 mg TDF/ 200mg FTC
Pregnantexperimental

Pregnant cisgender women will receive a single tablet of co-formulated 300 mg TDF/ 200mg FTC once daily (7 doses per week).

Drug: co-formulated 300 mg TDF/ 200mg FTC

Interventions

co-formulated 300 mg TDF/ 200mg FTCdrug

Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 300 mg TDF/ 200mg FTC