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 patients naive for HIV and HCV. Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.
This is a pilot, randomised, open label, controlled clinical trial. All eligible patients (CD4 count \> 200 and no PI resistance)will receive 26 weeks induction HAART (LPV/r + selected NUCS). At the end of induction period (Phase I), all subjects with negative HIV-RNA from at least two months, Hb \> 11 g/dL and CD4 count \> 350 cells/mmc will be randomised (1:1), to receive LPV/r new tabs (200/50 mg, 2 cpr BID) monotherapy (arm A) or to continue the same HAART (arm B), associated to anti-HCV therapy for other 48 weeks (Phase II). The number of subjects to recruit will be 60 subjects to start the induction-phase with the aim to randomize, at least 25 subjects in each arm of the study. The total number of subjects to randomize will be 50. The Group A: will receive LPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. Group B: will receive LPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision.All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)
NRTIs for 26 weeks (A) or 24 weeks (B)
PEG-IFNa 2a 180 mcg/week (48 weeks)
Ribavirin 1-1.2 g/day (48 weeks)
San Raffaele Hospital Dep. Infectious Diseases
Milan, Italy
RECRUITINGTo assess if the combination of LPV/r monotherapy in association with
Time frame: 18 months
anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional
Time frame: 18 months
toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin
Time frame: 18 months
in patients naïve for HIV and HCV
Time frame: 18 months
To assess if LPV/r monotherapy during the HCV treatment
Time frame: 18 and 24 months
is associated with anti HIV efficacy and a better patient satisfaction
Time frame: 18 and 24 months
vs optimized HAART.
Time frame: 18 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.