Hiv Infections Clinical Trial
Official title:
Randomized Non-inferiority Trial Comparing the Nevirapine-based Antiretroviral Therapy Versus the Standard Efavirenz-based ART for the Treatment of HIV-TB Co-infected Patients on Rifampicin-based Therapy (ANRS 12146 CARINEMO)
The purpose of this study is to determine whether the use of Nevirapine in HIV patients already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as Efavirenz.
Anti Retroviral Therapy (ART) reduces tuberculosis (TB) incidence in HIV-infected patients
and reduces mortality among TB patients with deep immune suppression. The Fixed Drug
Combination (FDC) nevirapine (NVP)-lamivudine-stavudine is the first line ART available for
low-income countries. Rifampicin (RMP), due to its liver induction effect, reduces
significantly NVP plasma concentration, raising concerns regarding the risk of resistance
and subsequent treatment failure. Therefore, in co-infected patients, WHO recommends
delaying ART or using efavirenz (EFV)-based ART. Although EFV is also reduced at lower
level, longitudinal studies report good efficacy and safety when given concomitantly with
RMP.
In low-income countries, poor access to EFV, contradiction during pregnancy and absence of
FDC containing EFV lead to difficulties in HIV-TB treatment.
Despite 2 limited retrospective studies and a non-randomised prospective study, which report
good virological response at 6 months in co-infected patients receiving NVP and RMP
co-administration, existing data are too limited to change the recommendation.
The aim of the study is to compare, in terms of therapeutic efficacy and clinical safety,
the nevirapine-based HAART to the standard efavirenz-based HAART, in HIV/TB co-infected
patients receiving a rifampicin-based TB treatment.
The study will evaluate one year after TB treatment initiation, whether the HAART efficacy
(virological outcome, death or lost of follow-up) induced by NVP-based HAART is non-inferior
to those induced by EFV based HAART, in patients receiving concomitantly HAART and RMP-based
TB treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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