Clinical trial · Interventional
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients
A Pilot Study of Pharmacokinetics, Tolerance and Efficacy of Raltegravir Combined to Two Fully Active Molecules Among Nucleosi(ti)de Analogs and Enfuvirtide Before and After Liver Transplant in HIV Infected Patients With End Stage Liver Disease (ANRS 148 LIVERAL)
NCT01022476CI-TRIAL-00107334LIVERALcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Evidence of Liver Transplantation | — | UNRESOLVED | — |
| HIV Infection | — | UNRESOLVED | — |
| Liver Failure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Raltegravir potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Raltegravir potassium
- description
- raltegravir 400 mg twice a day
- interventionNames
- Drug: Raltegravir potassium
Primary outcomes (1)
- measure
- 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
Secondary outcomes (4)
- measure
- To assess the maintenance of the virological efficacy on HIV of raltegravir combined with two fully active molecules among NRTI (or NRTI + enfuvirtide). Follow-up over a 3-months period before and after transplantation
- timeFrame
- from day 0 to month 3 for period 1 and period 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 "possible resistance" * Patient not having experienced viral escape during treatment combining 3TC, FTC or raltegravir * Patient registered with or covered by a social security scheme * For women of child-bearing potential, use of a barrier contraceptive method during sexual intercourse and negative pregnancy test (plasma ß-HCG ) at screening visit * Informed consent form signed at screening visit at the latest Exclusion Criteria: * More than two virological failures during antiretroviral treatment * Currently receiving treatment with an agent in development (apart from an authorization for temporary use) * Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months * Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception * All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol * Patient not having any effective options for NRTI +/- enfuvirtide (defined in the inclusion criteria) * Ongoing treatment with interferon-alpha or ribavirin for hepatitis C * Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations: * anti-infective agents: rifampicin/rifampin * psychotropic/antiepileptic agents: phenytoin, phenobarbital, carbamazepine * steroidal anti-inflammatory drug: dexamethasone
References
Publications (0)
Data not yet available
No reference posted for this study.