patients affected by HIV and chronic HCV or compensated cirrhosis MedDRA version: 6.1 Level: PT Classification code 10000807
Conditions
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is >18 years old - Subject has given written informed consent - Subject has a confirmed diagnosis of HIV and HCV infection - Subject is naive for HCV-infection treatment - Subject has chronic hepatitis and/or subject has compensated cirrhosis (Child class A) (Appendix 4) - Subject has a CD4+ count of > 350 cell/mmc - Subject is HIV-RNA negative during the previous six month - Subject is on stable HAART including r/LPV for > 6 months - Subject has genotype available at baseline and no mutations associated with resistance to PI (32, 33, 46, 47, 50, 54, 82, 84, 90) - Free of any clinically significant disease (other than HIV and HCV) that would interfere with study evaluations. - Subject will use effective contraceptive methods for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subject is HbsAg positive - Subject has cirrhosis score Child-Pugh B/C, - No previous hepatic decompensation - Subject has HIV-related thrombocytopenia (Platelets count 1.5 mg/dL - Subject is pregnant or wishes to become so - Subject has any cause of liver disease other than chronic hepatitis C, status of liver decompensation or any other condition consistent with decompensated liver disease (bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy) - Subject is alcohol abuser (> 30 gr/die) - Subject has autoimmune hepatitis - Prior treatment with PEG-IFN or ribavirin - Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (Metadone sostitution therapy allowed) - Active heart disease (e.g. angina, congestive heart failure, recent myocardial infarction or significant arhytmia) - Subject has pre-existing severe depression, condition of severe psychiatric disorders such as suicidal ideation, suicide attempts, depression or acute psychosis - Subject has uncompensated diabetes - Subject has active opportunistic infections or major opportunistic infections during the previous 12 months - Subject has known hypersensitivity or controindication to study medications - Subject has any other condition that in the opinion of the investigator will make the subject unsuitable for enrolment or will interfere with the subject participating in or completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess if the combination of LPV/rtv monotherapy with anti-HCV therapy (PEG IFN + Ribavirin) does not match with additional toxicity induced by the combination of optimized HAART (Lopinavir/rtv + selected Nucs) and anti-HCV-drugs.;Secondary Objective: - To assess if lopinavir/ritonavir monotherapy during the HCV treatment is associated with a better patients? satisfaction versus optimized HAART; - To assess HIV and HCV virological efficacy ; - To assess the number and type of HIV-resistance mutations in patients with virological failure;Primary end point(s): proportion of reduction or stopping anti-HCV therapy at 48 weeks due to at least one of the following AEs: : -haematological abnormalities (anaemia: Hb 15% of baseline value) -mitochondrial toxicity (hyperlactatemia grade 3-4, pancreatic enzime levels increase grade 3-4) -hepatic impairment (ascites, bleeding from esophageal varices, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatic neoplasia) Some rare adverse events, such as thyroid disfunction, will also be considered | — |
Countries
Italy
Outcome results
None listed