Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis (LIVERAL)
|ClinicalTrials.gov Identifier: NCT01289951|
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : February 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Hepatitis C||Drug: Raltegravir 400 mg/12hours||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Open Label, Unicentric Study of Multiple-dose Pharmacokinetics of Raltegravir in Patients Infected With Human Immunodeficiency Virus and Hepatitis C Virus With and Without Advanced (Child-Pugh C) Hepatic Cirrhosis.|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||October 2011|
U.S. FDA Resources
Experimental: Patients with Child-Pugh C hepatic-cirrhosis.
VIH/VHC coinfected patients with advanced (Child-Pugh C) hepatic cirrhosis.
|Drug: Raltegravir 400 mg/12hours|
|Active Comparator: VIH/VHC coinfected patients without liver damage.||Drug: Raltegravir 400 mg/12hours|
- The area under the curve (AUC0-12) calculated from plasma concentrations, the maximum concentration (Cmax) and the the minimum concentration (Cmin) of Raltegravir 400 mg/12 hours in the steady state for both arms. [ Time Frame: On the fifth day of treatment with raltegravir ]On the fifth day of treatment, patient will be hospitalized in the clinical trial unit in order to obtaine plasma concentrations previous to the administration of the corresponding dose (basal) and at the following times post-administration: 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, and 12h. With these measures, (AUC0-12), Cmax and Cmin will be calculated in order to describe the pharmacokinetic of Raltegravir 400 mgBID in the steady state in both arms
- Change from baseline in hematology and biochemistry parameters at day 5 and 15, number of adverse events (serious and non serious) notified and number of patients who discontinue the study (drop-out rate). [ Time Frame: On day 1, 5 and 15 ]Hematology and biochemistry parameters, adverse events notified during the study and drop-out rate will be recorded in order to evaluate the safety and tolerability of multiple doses of raltegravir in HIV/HCV coinfected patients, with no liver damage and with advanced cirrhosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289951
|Hospital Universitario Ramón y Cajal.|
|Madrid, Spain, 28034|
|Principal Investigator:||Santiago Moreno Guillen, MD||Hospital Universitario Ramón y Cajal. Madrid|