Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01289951
Eligibility Criteria:
Inclusion Criteria:
* Adults, clinically stable HIV/HCV coinfected patients on HAART with controlled viremia (\<50 copies/ml) for at least 6 months. HAART will be based on a boosted protease inhibitor (lopinavir, fosamprenavir or darunavir). Hepatic Stability is defined by the absence of new events of descompensation (Child-Pugh score) in the previous six weeks with no data of progressive hepatic insufficiency.
* Liver biopsy performed during the previous year showing no liver damage (F0-F1 in the Metavir score) or by elastometry results ≤ 6 Kpa, to classify patients in group B.
* Liver cirrhosis guided by biopsy (F4 in the Metavir score) or elastometry: results ≥ 14 Kpa, to classify patients in group A.
* Body mass index (BMI) in the range of 19-35 kg/m2.
Exclusion Criteria:
* HBV surface antigen positive.
* Clinical demonstration of a new descompensation event in the previous 6 weeks.
* Alcohol abuse as an average daily consumption \> 20g.
* Treatment with boosted atazanavir, saquinavir or indinavir.
* Concomitant treatment with phenytoin, phenobarbital and rifampinor other UGT1A1 inhibitors.
* Use of any investigational agents (other than ART on expanded access) within 90 days of randomization.
* Active or previous HCV treatment with Ribavirin and /or Peg-interferon if sustained virological response achieved.
* Women taking oral contraceptives
* Pregnancy and lactancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01289951
Study Brief:
Protocol Section:
NCT01289951