CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
Tenofovir alafenamide +1 moredrug
Likely dose
Tenofovir alafenamide 200 mgfrom 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/NCT04937881
NCT04937881Phase 3Completed
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Comparison of Pharmacokinetics of Tenofovir Alafenamide (TAF) With Tenofovir Disoproxil (TDF) in Pregnant and Postpartum Women and Their Infants in PrEP-PP Study

University of California, Los Angeles·interventional·Posted Jun 24, 2021·Updated Sep 3, 2024

In Brief

A Phase 3 clinical trial evaluating Tenofovir alafenamide and Tenofovir Disoproxil Fumarate for Hiv. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum. Study Investigators will recruit from an ongoing observational cohort study in Cape Town, South Africa, PrEP-PP (recruitment ongoing through July, 2021; NIMH R01MH116771; PI Coates \& Myer). Findings form this PK sub-study will be used to inform future PrEP in pregnancy and postpartum studies and develop benchmarks of the relative PK between TDF and TAF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiv
CountriesSouth Africa
CollaboratorsUniversity of Cape Town, Desmond Tutu HIV Foundation, Gilead Sciences

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJun 24, 2021
Enrollment StartJun 13, 2022
Primary CompletionApr 17, 2023
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.0 years ago

Interventions

Tenofovir alafenamidedrug

Daily DOT fixed dose combination of 200 mg emtricitabine (FTC) and 25 mg tenofovir alafenamide (TAF)

Tenofovir Disoproxil Fumaratedrug

Daily DOT fixed dose combination of 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF)