At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
TAF/EVG Insertdrug
Likely dose
TAF/EVG Insert 16 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.
A Phase 1 Open Label Safety and Pharmacokinetic Study of Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 6, 2019·Updated Dec 22, 2023
In Brief
A Phase 1 clinical trial evaluating TAF/EVG Insert for HIV Infections. Completed, enrolled 23 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsCONRAD
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartDec 2019
Primary CompletionMar 2021
Study CompletionApr 2021
TodayJul 2026
First PostedAug 6, 2019
Enrollment StartDec 11, 2019
Primary CompletionMar 3, 2021
Study CompletionApr 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.9 years ago
Interventions
TAF/EVG Insertdrug
TAF/EVG Insert (20/16 mg) administered rectally by study staff