Status:
COMPLETED
Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once ...
Detailed Description
The proposed research consists of conducting a pilot trial "BKVIR" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well to...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years
- Infected by HIV-1
- Naive to antiretroviral therapy
- Presenting an indication to start antiretroviral therapy (according to the recommendations of the Delfraissy 2004 report)
- Histologically or microbiologically confirmed tuberculosis
- Receiving tuberculostatic therapy for less than three months
Exclusion
- Isolated HIV-2 infection
- Neoplasm treated by chemotherapy and/or radiotherapy
- Pregnancy or plans for pregnancy
- Breastfeeding
- Contraindication to one of the antiretroviral drugs
- Atypical mycobacterial infection
- Hemoglobin below 8 g/dL
- Neutrophils below 750/mm3
- Platelets below 50,000/mm3
- Creatinine clearance below 60 ml/min
- Alkaline phosphatase, ASAT, ALAT or bilirubin over 3 times the upper limit of normal
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00115609
Start Date
January 1 2006
End Date
November 1 2009
Last Update
December 22 2011
Active Locations (1)
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1
Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades
Paris, France, 75015