Who is sponsoring NCT00592124?

NCT00592124 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What condition does NCT00592124 study?

NCT00592124 studies HIV Infections.

What drugs are being tested in NCT00592124?

Interventions: Tenofovir disoproxil fumarate, Tenofovir gel.

What is the status of NCT00592124?

NCT00592124 is currently COMPLETED.

Last reviewed 2021-10-15 · How we verify

Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir

NCT00592124 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	COMPLETED
Enrolment	168
Start date	2008-06
Completion	2010-07

Conditions

HIV Infections

Interventions

Tenofovir disoproxil fumarate
Tenofovir gel

Primary outcomes

Self-reported Adherence to Each Regimen — Measured through Week 21
Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.
Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future — Measured through Week 21
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) — Measured through Week 21
PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.

Countries

United States, South Africa, Uganda