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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 3

Conditions: Tuberculosis; HIV Infections

Treatments: Drug: efavirenz; Drug: tenofovir DF; Drug: emtricitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00115609

ANRS129 BKVIR

2005-002470-30

Details and patient eligibility

About

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.

Full 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 tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients. As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. The initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy.

This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients. The data collected will constitute a unique database on this issue not only in France, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)