PATIENTS AFFECTED BY HIV/HCV NAIVES FROM THERAPIES MedDRA version: 6.1 Level: PT Classification code 10000807
Conditions
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess if the combination of LPV/r monotherapy in association with anti-HCV therapy (PEG IFN + Ribavirin) does not match with additional toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected NUCS) and PEG-IFN + Ribavirin.;Secondary Objective: to assess if LPV/r monotherapy during the HCV treatment is associated with anti-HIV efficacy and better patient satisfaction vs. optimized HAART;Primary end point(s): to compare, between the two arms, the proportion of reduction or stopping of anti-HCV therapy at 18 months due to at least one of the following AEs: -haematological abnormalities (anaemia: Hb 15% of baseline value) -mitochondrial toxicity (hyperlactatemia grade 3-4, pancreatic enzymes 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 dysfunction, will also be considered. | — |
Countries
Italy
Outcome results
None listed