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VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer

NCT00828789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C
  • HCV
  • HIV
  • AIDS

Interventions

DRUG

Efavirenz; Tenofovir disoproxil fumarate; Telaprevir

Sponsors & Collaborators

  • Tibotec BVBA

    lead INDUSTRY

Principal Investigators

  • Tibotec-Virco Virology BVBA Clinical Trial · Tibotec BVBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828789 on ClinicalTrials.gov