Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-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 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.

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

Details

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

Criteria

Inclusion 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)

• Subject has a CD4+ count > 200 cell/mm3 and <500 cell/mm3.

• Subject has genotype available at baseline and no mutations (IAS)associated with resistance to antiretroviral drugs used.

• Subject and partner 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 < 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