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Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis

NCT00474435 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-12-17

No results posted yet for this study

Summary

In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.

Conditions

Interventions

DRUG

Emtricitabine/tenofovir/efavirenz

Co-formulated in one tablet (taken once daily by oral administration): * emtricitabine 200 mg * tenofovir DF 300 mg * efavirenz 600 mg

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Kilimanjaro Christian Medical Centre, Tanzania

    collaborator OTHER

  • African Poverty Related Infection Oriented Research Initiative

    lead OTHER

Principal Investigators

  • Martin Boeree, MD, PhD · University Lungcentre Dekkerswald, Groesbeek / University Medical Centre Nijmegen, the Netherlands

  • David Burger, PharmD, PhD · University Medical Centre Nijmegen, the Netherlands

  • Gibson Kibiki, MMed, PhD · Kilimanjaro Christian Medical Centre,Moshi,Tanzania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Tanzania

Study Locations

More Related Trials

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 NCT00474435 on ClinicalTrials.gov