NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 3

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: HIV Infections, Tuberculosis

Interventions: efavirenz, tenofovir DF, emtricitabine

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Paris, France