At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 168 enrolled
Drug / intervention
Tenofovir disoproxil fumarate +1 moredrug
Likely dose
Tenofovir disoproxil fumarate 300 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.
Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 11, 2008·Updated Oct 19, 2021
In Brief
A Phase 2 clinical trial evaluating Tenofovir disoproxil fumarate and Tenofovir gel for HIV Infections. Completed, enrolled 168 participants across 7 sites in 3 countries.
Detailed Summary
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa, Uganda, United States
CollaboratorsMicrobicide Trials Network
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2008
Enrollment StartJun 2008
Primary CompletionJul 2010
TodayJul 2026
First PostedJan 11, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.5 years ago
Interventions
Tenofovir disoproxil fumaratedrug
300 mg tablet daily
Tenofovir geldrug
1 gm/100 ml of 1% gel vaginally daily