HIV Infections Clinical Trial
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
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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