Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection recommend a combination antiretroviral regimen composed of two nucleoside reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor. The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine) and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term efficacy. The overall intention of this trial is to examine in a non-inferiority design the safety and efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected patients. The standard of care used in this study will be atazanavir/ritonavir. All patients will in addition receive a fixed combination of tenofovir and emtricitabine. The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients will be randomized 1:1 to either the experimental or the active control arm
Patients will be randomized 1:1 to either the experimental or the active control arm
Auguste Viktoria Hospital (AVK)
Berlin, Germany
Praxiszentrum Kaiserdamm
Berlin, Germany
Private Practice Dupke, Carganico, Baumgarten
Berlin, Germany
Department of Internal Medicine I, Bonn University
Bonn, Germany
University of Essen
Essen, Germany
Infektiologikum Frankfurt
Frankfurt am Main, Germany
University of Frankfurt
Frankfurt am Main, Germany
Infektionsmedizinisches Centrum Hamburg (ICH)
Hamburg, Germany
Primary objective
1. there is no difference in the rate of grade 1/2, or 3/4 ALT elevations 2. there is a higher incidence of grade 1 - 4 hyperbilirubinemias in the ATV/r arm
Secondary objectives
Other parameters of safety and efficacy will be compared between both arms
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