Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANR… (NCT00115609) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)
France70 participantsStarted 2006-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
treatment success rate at week 48 (W48)
Timeframe: W48
Trial details
NCT IDNCT00115609
SponsorFrench National Agency for Research on AIDS and Viral Hepatitis