HIV/ HCV Coinfection MedDRA version: 9.1 Level: LLT Classification code 10020443 MedDRA version: 9.1 Level: PT Classification code 10019751
Conditions
Interventions
Trade Name: CELSENTRI
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Maraviroc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: REYAT
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with documented HIV-1/HCV (HCV-RNA detectable at quantitative assay) co-infection 2. Male or female ages > 18 years old 3. Patients who have voluntarily signed and dated the CI 4. Patients currently receiving a PI based HAART for at least 24 weeks based on Truvada plus Atazanavir 300 mg/ritonavir 100 mg QD 5. Patients taking the same ARV combination for at least 8 weeks before enrolment 6. Plasma HIV-RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previously demonstrated clinically allergy or hypersensitivity to any excipients of the investigational medications 2. Ongoing treatment with immunomodulant drugs or growth factors (IL-2, G-CSF, GM-CSF) 3. Treatments with steroids within 4 weeks before the enrolment 4. Need to use pegIFN/RBV in the next two years 5. Patients with Child Pugh > A 6 6. Patients co-infected with HBV (HBsAg+) 7. Patients with autoimmune diagnosed disorders 8. Active drug abuse including alcohol or recreational drugs which, in the opinion of the investigator is expected to interfere with the patient?s ability to adhere to the study procedures and treatment regimen. Patients on a methadone program will be accepted if deemed appropriate by the investigator 9. Patients with a grade 3/4 laboratory abnormality defined by DAIDS grading table 10. Pregnant and breastfeeding women 11. Any active clinically significant diseases or life threatening diseases or findings during screening of medical history or physical examination that in the investigator?s opinion, would compromise the patient?s safety and outcome of the study 12. Use of disallowed concomitant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary end point: The primary end point is to evaluate the proportion of patients with change in the fibrosis stage in the two arms at 48th and 96th week defined by 1) Elastometry - Fibroscan : 2) Fibrotest ;Secondary Objective: Secondary end points: To compare change from baseline to week 24, 48 and 96 of: 1) Change of liver fibrosis score at Fibrotest and Fibroscan from baseline at week 24,48,96 in two arms 2) Change of fibrogenesis biomarkers plasma concentration (jaluronic acid and TIMP-1) from baseline at week 12,24,48,96 in two arms 3) Change from baseline at week,24,48,96 in two arms of: - AST/ALT - ALP, GGT, Bil tot (direct and indirect) - Quantitative HCV-RNA - PCR, Alfa 1 antitripsin, procalcitonin, fibrinogen, didimer - Total Cholesterol, LDL, HDL, triglycerides, HOMA score (calculated as fasting glucose mmol x fasting insulin mmol /22,5) - HIV-RNA; T CD4+, CD8+, CD4/CD8;Primary end point(s): The primary end point is to evaluate the proportion of patients with change in the fibrosis stage in the two arms at 48th and 96th week. Liver Fibrosis stage will be defined with: Elastometry - Fibroscan (34): F0-1: 12,5 Kpa Fibrotest  : (35) F1-2: 0,73(0,69-0,77) | — |
Countries
Italy
Outcome results
None listed