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

• Conditions: PATIENTS AFFECTED BY HIV/HCV NAIVES FROM THERAPIES; MedDRA version: 6.1Level: PTClassification code 10000807

• Registration Number: EUCTR2006-005996-17-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

To be eligible for study participation, a subject must meet all the following criteria: - Subject is >18 years old - Subject has given written informed consent - Serologic evidence of HIV infection by HIV antibody and HIV-RNA detection - Serologic evidence of HCV infection by HCV antibody and HCV-RNA detection - Subject is naive for HIV and HCV therapy - Subject has active chronic hepatitis or compensated cirrhosis (Child-Pugh class A:(see appendix 5). - Subject has a CD4+ count > 200 cell/mm3 and <500 cell/mm3. - Subject has genotype available at baseline and no mutations associated with clinical resistance to antiretrovirals used, absence of mutations related to PI failure (32, 33, 46, 47, 50, 54, 82, 84, 90). - Subject and partner 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 < 9 g/dL at screening and <11 g/dL at randomization - -Subject has creatinine value > 1.5 mg/dL - Subject is on a HAART regimen included ddI and/or AZT - 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) - Prior treatment with PEG-IFN/ribavirin - Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (maintenance treatment with methadone allowed) - Active heart disease (e.g. angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia) - 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 any condition for which the investigator feels the subject is unsuitable for the trial. - Subject has known hypersensitivity or contraindication 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