Who is sponsoring NCT00828789?

NCT00828789 is sponsored by Tibotec BVBA.

What condition does NCT00828789 study?

NCT00828789 studies Hepatitis C, HCV, HIV, AIDS.

What drugs are being tested in NCT00828789?

Interventions: Efavirenz; Tenofovir disoproxil fumarate; Telaprevir.

What is the status of NCT00828789?

NCT00828789 is currently COMPLETED.

Last reviewed 2010-12-16 · How we verify

A Phase I, Open-label, Randomized, Crossover Trial in 20 Healthy Subjects to Investigate the Pharmacokinetic Interactions Between the Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir.

NCT00828789 Phase 1 COMPLETED

The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect of TVR on the pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will be evaluated.

Details

Lead sponsor	Tibotec BVBA
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2009-02
Completion	2009-04

Conditions

Hepatitis C
HCV
HIV
AIDS

Interventions

Efavirenz; Tenofovir disoproxil fumarate; Telaprevir

Primary outcomes

The primary objectives are to determine the effect of EFV and TDF on the pharmacokinetics of TVR and VRT-127394 and of TVR every 8h and every 12h on the pharmacokinetics of EFV and TDF.