HIV InfectionPhase 1/2LIVERALNCT01022476
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients
A Phase 1/2 study testing Raltegravir potassium in people with HIV Infection and Liver Failure, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Liver Failure, Evidence of Liver Transplantation
- What is being tested?
- Raltegravir potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to May 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne, Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94275
About this study
Official title: 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)
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.
Read the detailed description
HIV infected patients with stable plasma HIV-RNA below 50 copies per mL and severe liver dysfunction will be switched from their antiretroviral regimen to a combination of raltegravir (one 400 mg pill twice daily) and two fully active molecules among nucleosi(ti)de analogs and enfuvirtide for a first period of at least 3 months and a second period of at least 3 months after liver transplantation, if need be, when a steady state of the anticalcineurin will be reached. Pharmacokinetic parameters of raltegravir will be calculated during severe liver dysfunction period and after liver transplantation. Pharmacokinetic parameters of cyclosporine (or tacrolimus if contra indication to cyclosporine) will be compared when administrated alone or combined with raltegravir. Patients will be followed up according to standard of care. This study will be divided in two distinct periods (1 and 2) lasting 3 months each. Period 1 will start from the inclusion in the study and will generally include the switch to raltegravir. Period 2 will start from liver transplantation.
- Being tested
- Raltegravir potassium
- Keywords
- Pharmacokinetics, Raltegravir, Immunosuppressive Agents, Severe hepatic insufficiency, Liver Transplantation, Additional Keywords, HIV Infection, Hepatocarcinoma, Hepatitis C, Hepatitis B
- Medical subject headings
- HIV Infections, Liver Failure, Hepatic Insufficiency, Carcinoma, Hepatocellular, Hepatitis C, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir potassiumDrug
Also called ISENTRESS
one pill of raltegravir 400 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir potassium | Experimental | raltegravir 400 mg twice a day Receives: Drug: Raltegravir potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at month 1 for period 1 and day 7-month 1 for period 2
Secondary outcomes (4)
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
Measured: from day 0 to month 3 for period 1 and period 2
To assess the safety of raltegravir before transplantation in patients with impaired liver function, and after transplantation in combination with immunosuppressive treatment
Measured: from day 0 to month 3 for period 1 and period 2
To describe the clinical outcome of patients (such as the onset of opportunistic infections, relapse of HCV infection, morphological and metabolic disorders outcomes)
Measured: from day 0 to month 3 for period 1 and period 2
To describe the changes in liver function (evaluation of liver function during treatment) before and after liver transplantation
Measured: from day 0 to month 3 for period 1 and period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Elina TEICHER, MD, Principal investigator, Hôpital de Bicêtre - LE KREMLIN-BICETRE - FRANCEJean-Pierre ABOULKER, MD, Study chair, INSERM SC10 VILLEJUIF FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022476
- Sponsor's protocol ID
- ANRS 148 LIVERAL
- Other IDs
- 2009-014616-36, 2009
- Acronym
- LIVERAL
- Status last verified
- Jul 2013
- First submitted
- 26 Nov 2009
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01022476
- Acronym / sponsor ID
- LIVERAL / ANRS 148 LIVERAL
- Keywords
- Pharmacokinetics, Raltegravir, Immunosuppressive Agents, Severe hepatic insufficiency, Liver Transplantation, Additional Keywords, HIV Infection, Hepatocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HIV infected patients with stable plasma HIV-RNA below 50 copies per mL and severe liver dysfunction will be switched from their antiretroviral regimen to a combination of raltegravir (one 400 mg pill twice daily) and two fully active molecules among nucleosi(ti)de analogs and enfuvirtide for a first period of at least 3 months and a second period of at least 3 months after liver transplantation, if need be, when a steady state of the anticalcineurin will be reached. Pharmacokinetic parameters of raltegravir will be calculated during severe liver dysfunction period and after liver transplantation. Pharmacokinetic parameters of cyclosporine (or tacrolimus if contra indication to cyclosporine) will be compared when administrated alone or combined with raltegravir. Patients will be followed up according to standard of care. This study will be divided in two distinct periods (1 and 2) lasting 3 months each. Period 1 will start from the inclusion in the study and will generally include the switch to raltegravir. Period 2 will start from liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir potassium | Experimental | Drug: Raltegravir potassiumraltegravir 400 mg twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raltegravir potassiumAlso: ISENTRESSone pill of raltegravir 400 mg twice a day | Drug | Raltegravir potassium |
Primary outcome
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
Time frame: at month 1 for period 1 and day 7-month 1 for period 2
4 secondary outcomes
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
Time frame: from day 0 to month 3 for period 1 and period 2
To assess the safety of raltegravir before transplantation in patients with impaired liver function, and after transplantation in combination with immunosuppressive treatment
Time frame: from day 0 to month 3 for period 1 and period 2
To describe the clinical outcome of patients (such as the onset of opportunistic infections, relapse of HCV infection, morphological and metabolic disorders outcomes)
Time frame: from day 0 to month 3 for period 1 and period 2
To describe the changes in liver function (evaluation of liver function during treatment) before and after liver transplantation
Time frame: from day 0 to month 3 for period 1 and period 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Agence nationale de recherches sur le sida et les hépatites viralesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elina TEICHER, MD principal investigator
Hôpital de Bicêtre - LE KREMLIN-BICETRE - FRANCE
Jean-Pierre ABOULKER, MD study chair
INSERM SC10 VILLEJUIF FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Raltegravir potassium in people with HIV Infection and Liver Failure, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: at month 1 for period 1 and day 7-month 1 for period 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.