NCT00828789

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 17, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

January 22, 2009

Last Update Submit

December 16, 2010

Conditions

Hepatitis CHCVHIVAIDS

Keywords

Hepatitis CHCVHIVAIDSTelaprevirEfavirenzTenofovir disproxil fumarateHealthy volunteerVX-950-C134VX-950-TiDP24-C134HIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • The secondary objective is to determine the short-term safety and tolerability of the coadministration of TVR, EFV and TDF.

Interventions

Efavirenz; Tenofovir disoproxil fumarate; TelaprevirDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females should be post-menopausal (amenorrheal for at least 3 years), or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
  • Normal weight at screening as defined by a body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
  • Normal 12-lead ECG at screening
  • Healthy on the basis of a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
  • Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening.

You may not qualify if:

  • No history or presence of relevant drug or food allergies, cardiovascular or central nervous system disease, clinically significant pathology, mental disease or psychiatric disorders, chronic skin disease, or drug abuse
  • Current use of prescription medication
  • Regular treatment with over-the-counter medications
  • Consumption of herbal medications or dietary supplements
  • A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs
  • Participation in a clinical study within 2 months or 5 half lives of the investigational drug prior to the screening visit
  • No positive HIV test or hepatitis A, B or C infection
  • Having any history of renal disease
  • Male subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis CAcquired Immunodeficiency SyndromeHIV Infections

Interventions

efavirenzTenofovirtelaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tibotec-Virco Virology BVBA Clinical Trial

    Tibotec BVBA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 17, 2010

Record last verified: 2010-12