Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Collaborators: Abbott; Hoffmann-La Roche
• Treatments: Interferon-alpha; Lopinavir; Peginterferon alfa-2a; Ribavirin; Ritonavir

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)

• 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 or no virologic failure on PI treatment, defined as a confirmed HIV-RNA level>50 cp/mL after 24 weeks, > 50 cp/ml after 48 weeks, or a repeated HIV RNA level > 50 cp/mL after prior suppression of viremia to< 50 cps/mL.

• 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

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 (Methadone sostitution therapy 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 major opportunistic infections during the previous 12 months

• 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