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VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir

NCT01253551 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-10-16

No results posted yet for this study

Summary

The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV infection.

Conditions

  • Hepatitis C

Interventions

DRUG

Treatment sequence AB

Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.

DRUG

Treatment sequence BA

Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.

Sponsors & Collaborators

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
2010-12-31
Completion
2011-04-30

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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 NCT01253551 on ClinicalTrials.gov