Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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 daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Efavirenz; Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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