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

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis (Other)

Overall Status

Completed

CT.gov ID

NCT00115609

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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 daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: efavirenz Drug: tenofovir DF Drug: emtricitabine	Phase 3

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Outcome Measures

Primary Outcome Measures

treatment success rate at week 48 (W48) [W48]

Secondary Outcome Measures

course of plasma HIV-1 RNA between W0 and W48 [W48]
tuberculosis cure rate [W48]
safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome) [W48]
frequency of treatment changes or discontinuations [W48]
clinical progression of HIV infection [W48]
course of CD4 and CD8 T lymphocytes [W48]
study of resistance in the case of virological failure [W48]
study of compliance and quality of life [W48]
pharmacokinetic study of tuberculostatic agents [W02,W08,W12, W24]
effect of treatment on hepatitis B viral replication [W48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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