Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients (NCT01022476) | Clinical Trial Compass
CompletedPhase 1/2
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients
France14 participantsStarted 2010-05
Plain-language summary
This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18
* Documented HIV-1 infection, hepatitis B or C co-infection is allowed
* Plasma viral load at screening visit below 50 copies per mL for at least 6 months
* Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1
* Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2
* Abstinence from alcohol intake for at least 6 months (WHO norm)
* Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted)
* No ongoing class C opportunistic infection (1993 CDC classification)
* Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide
* Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active\* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide
\*An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "p…
What they're measuring
1
Pharmacokinetic parameters of raltegravir in patients with severe liver dysfunction and after a liver transplantation when combined to immunosuppressive therapy. Pharmacokinetic parameters of immunosuppressive drugs with or without raltegravir
Timeframe: at month 1 for period 1 and day 7-month 1 for period 2