The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in HIV/HCV coinfected patients. Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy versus optimized HAART.
This is a pilot, randomised, open label, controlled clinical trial. All eligible patients(CD4\>350, HIV RNA\<50 copies and no PI mutations) will be randomized (1:1) to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or LPV/r + selected NUCS (arm B) associated to anti-HCV therapy for 12 months. The number of subjects to recruit, in each arm of the study, is equal to 25, the total number of subjects to enrol will be 50. * Group A: will receive LPV/r monotherapy and anti HCV drugs for 12 months. * Group B: will receive LPV/r+ selected NUCS and anti HCV drugs for 12 months. All the patients will be followed-up for six months after the end of anti-HCV drugs for the evaluation of Sustained Virological Response (SVR). At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decisions.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day .At the end of the third month of combined therapy, only patients who reach an early virological response will continue anti-HCV drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
200/50 mg 2 cpr bid monotherapy
PEG-IFNa 2a 180 mcg/week
Ribavirin 1-1.2 g/day
Nucleoside Reverse Transcriptase Inhibitors
San Raffaele Hospital, Dep. Infectious Diseases
Milan, Italy
RECRUITINGTo assess if the combination of LPV/r monotherapy in association with anti-HCV
Time frame: 12 months
Nucs) and PEG-IFN alfa 2a +Ribavirin in patients naïve for HCV treatment
Time frame: 12 months
without previous failure or detection of any mutations related to PI resistance.
Time frame: 12 months
To assess if LPV/r monotherapy during the HCV treatment is associated with
Time frame: 12 and 18 months
anti HIV/HCV efficacy and a better patient satisfaction vs optimized HAART.
Time frame: 12 and 18 months
To assess the number and type of HIV-1 resistance mutations in patients with
Time frame: 12 and 18 months
virological failure
Time frame: 12 and 18 months
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