Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis
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Keep this study
Lead
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
With
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis
