A pilot, open label, multicenter, randomized clinical trial on Lopinavir/Ritonavir-monotherapy vs Lopinavir/Ritonavir plus selected Nucs, in HIV/HCV coinfected patients with chronic hepatitis C or compensated cirrhosis, starting treatment with Ribavirin and Pegylated Interferon - ND

• Conditions: patients affected by HIV and chronic HCV or compensated cirrhosis; MedDRA version: 6.1Level: PTClassification code 10000807

• Registration Number: EUCTR2006-006042-33-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- Subject is HbsAg positive - Subject has cirrhosis score Child-Pugh B/C, - No previous hepatic decompensation - Subject has HIV-related thrombocytopenia (Platelets count < 50.000/mmc) - Subject has neutrophils count < 1500/mmc - Subject has Hb value < 11 g/dL - Subject has creatinine value > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified