HIV-1 InfectionPhase 3ANRS153TREVENCT01453192
Renal Transplantation and Raltegravir in HIV-Infected Patients
A Phase 3 study testing Raltegravir in people with HIV-1 Infection and Chronic Renal Insufficiency, run by ANRS, Emerging Infectious Diseases at 14 sites in France.
Trial summary
The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV-1 Infection, Chronic Renal Insufficiency
- What is being tested?
- Raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 14 sitesFrance
- Study dates
- Dec 2011to Nov 2015
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registration on the French national renal transplantation waiting list (Biomedicines Agency) for a living or cadaveric donor organ
- HIV-1-infected patients treated by a three-drug ARV regimen
- Immuno-virologic criteria at renal transplantation: undetectable viral load (<50 copies/mL) and CD4 >200/mm3 for at least three months on stable ARV
- Age >18 years and <70 years
- Effective contraception for women
- Written informed consent
- Patient with social security coverage
Who cannot join
- Permanent:
- Hepatic cirrhosis
- Serious psychiatric illness history
- EBV or HHV8 lymphoproliferation (lymphoma, systemic Kaposi's sarcoma or multifocal Castleman's disease)
- History of PML
- HTLV-1 seropositivity
Show all 16Show fewer
- Severe pulmonary or cardiovascular disease with poor short-term vital prognosis
- Patient with AgHBs+
- History of cryptosporidiosis
- History of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy
- Impossibility or refusal of Raltegravir switch, decision made by doctor or patient
- Temporary:
- Recent malignancy (between 2 and 5 years according to type)
- HPV-related cervical or anal disease: carcinoma in situ, AIN III, CIN III in remission for less than three years
- Active infection
- HCV infection (PCR-positive)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse
Bordeaux, 33076
CHU De Caen, Service de Néphrologie Hémodialyse
Caen, 14033
Hôpital Henri Mondor, Service de Néphrologie Transplantation
Créteil, 94010
Hôpital Kremlin Bicêtre, Service de Néphrologie
Le Kremlin-Bicêtre, 94275
CHRU Lille, Service de néphrologie
Lille, 59037
CHU de Nantes, Service de Néphrologie et Immunologie Clinique
Nantes, 44093
Hôpital Pasteur, Service de Néphrologie - Transplantation
Nice, 06002
Hopital Saint Louis, Service de Néphrologie
Paris, 75010
Hôpital Necker, Service de Néphrologie adulte
Paris, 75743
Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale
Paris, 75970
Hôpital civil, Service de Néphrologie et Transplantation
Strasbourg, 67091
Hôpital Foch, Service de Néphrologie Transplantation
Suresnes, 92151
Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation
Toulouse, 31059
Hôpital Bretonneau, Service de Néphrologie
Tours, 37044
About this study
Official title: National, Multicenter, Phase III Prospective Trial About Clinical and Immunological Follow-up After Renal Transplantation in HIV-1 Infected Patients With End Stage Chronic Renal Insufficiency
The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir.
Read the detailed description
Antiretroviral treatment of HIV-1 Infection might interact with immunosuppressive treatments which increase rejection of renal graft incidence.
In addition HIV infection may be modified together with cardiovascular risk. Patients participating to this study will receive after transplantation antiretroviral regimen including Raltegravir.
Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.
- Conditions
- HIV-1 Infection, Chronic Renal Insufficiency
- Being tested
- Raltegravir
- Keywords
- Raltegravir, Renal transplantation, HIV-1, Acute renal graft rejection
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute clinical renal graft rejection
Incidence of acute clinical renal graft rejection defined by 20% increase of serum creatinine, associated to histological features (Banff classification) 6 months after renal transplantation
Measured: 6 months
Secondary outcomes (10)
Incidence of acute clinical and subclinical renal graft rejection
Incidence of acute clinical and subclinical renal graft rejection up to 1 year after renal transplantation defined only by renal histology (without creatinine modification). Histology is performed on routine renal graft biopsy 3 months and 1 year after transplantation.
Measured: 1 year
One year graft survival
One year graft survival, compared to non HIV-infected transplanted patients, using data provided by French Biomedicines Agency
Measured: 1 year
Patients' survival
Patients survival, compared to:
- chronic dialysis HIV patients still listed on the transplantation waiting list - transplanted non-HIV patients using data provide by French Biomedicine Agency
Measured: 1 year
Phenotyping of lymphocytic infiltrates in case of acute rejection
The aim of the immunological phenotyping is to analyse the expression of activation markers between different TCD4 and TCD8 sub-population, this phenotyping will be compared to those observed in acute cell-mediated rejection occurring in the historical cohort of Non-HIV patients. In addition, the rate and expression of Treg population will be evaluated.
Measured: 1 year
Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation
Severe morbidity diseases include: pathological infections, malignancies, metabolic and cardiovascular diseases.
Measured: 1 year
Immunological and virologic status after renal transplantation
Immunological (lymphocyte activation and inflammatory parameters) and virologic status (kinetics of viral replication: HIV RNA in blood, total HIV DNA in PBMC) monitoring after renal transplantation. These parameters will be compared with pre-transplant status.
Measured: 1 year
Evaluation of the switch by raltegravir at the time of renal transplantation
Assessment of ARV medications change and introduction of raltegravir at the time of renal transplantation in terms of reduction of pharmacokinetic interaction between antiretroviral regimen including raltegravir and immunosupressive treatments. In addition, virological efficacy of antiretroviral treatment including Raltegravir will be evaluated.
Measured: 1 year
Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation
The aim of this study is to evaluate at the time of renal transplantation the virologic efficiency after the switch by an antiretroviral regimen including Raltegravir in terms of viral load control an virological failure as Raltegravir is known for its low genetic barrier.
Measured: 1 year
Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation
Assessment of HIV patients' waiting period until renal transplantation and survival of patients registered on French biomedicine agency waiting-list compared to Non-HIV population (data provided by French Biomedicine Agency )
Measured: 1 year
Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir
Area under plasma concentration (AUC) of Raltegravir and immunosuppressive drugs (Tacrolimus and Mycophenolate Mophetyl) will be measured as well as residual concentration of Tacrolimus. This study is performed in order to verify immunosupressive treatments dosage adaptation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Philippe GRIMBERT, MD, Principal investigator, CHU Henri-MondorDominique COSTAGLIOLA, PHD, Study director, INSERM U943
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453192
- Sponsor's protocol ID
- ANRS 153 TREVE
- Other IDs
- 2011-001004-35
- Acronym
- ANRS153TREVE
- Status last verified
- Jul 2016
- First submitted
- 3 Oct 2011
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matignon M, Lelievre JD, Lahiani A, Abbassi K, Desvaux D, Diallo A, Peraldi MN, Taburet AM, Saillard J, Delaugerre C, Costagliola D, Assoumou L, Grimbert P; ANRS 153 TREVE study group. Low incidence of acute rejection within 6 months of kidney transplantation in HIV-infected recipients treated with raltegravir: the Agence Nationale de Recherche sur le Sida et les Hepatites Virales (ANRS) 153 TREVE trial. HIV Med. 2019 Mar;20(3):202-213. doi: 10.1111/hiv.12700. Epub 2019 Jan 27.
PubMed 30688008
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicenter, Phase III Prospective Trial About Clinical and Immunological Follow-up After Renal Transplantation in HIV-1 Infected Patients With End Stage Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT01453192
- Acronym / sponsor ID
- ANRS153TREVE / ANRS 153 TREVE
- Conditions
- HIV-1 Infection, Chronic Renal Insufficiency
- Keywords
- Raltegravir, Renal transplantation, HIV-1, Acute renal graft rejection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Oct 2011 (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.
The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir.
Detailed description
Antiretroviral treatment of HIV-1 Infection might interact with immunosuppressive treatments which increase rejection of renal graft incidence.
In addition HIV infection may be modified together with cardiovascular risk. Patients participating to this study will receive after transplantation antiretroviral regimen including Raltegravir.
Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: RaltegravirRaltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Registration on the French national renal transplantation waiting list (Biomedicines Agency) for a living or cadaveric donor organ
- HIV-1-infected patients treated by a three-drug ARV regimen
- Immuno-virologic criteria at renal transplantation: undetectable viral load (<50 copies/mL) and CD4 >200/mm3 for at least three months on stable ARV
- Age >18 years and <70 years
- Effective contraception for women
Key exclusion criteria (16 listed)
- Permanent:
- Temporary:
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 |
|---|---|---|
| RaltegravirAlso: IsentressIntroduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease | Drug | Raltegravir |
Primary outcome
Incidence of acute clinical renal graft rejection
Time frame: 6 months
Incidence of acute clinical renal graft rejection defined by 20% increase of serum creatinine, associated to histological features (Banff classification) 6 months after renal transplantation
10 secondary outcomes
Incidence of acute clinical and subclinical renal graft rejection
Time frame: 1 year
One year graft survival
Time frame: 1 year
Patients' survival
Time frame: 1 year
Phenotyping of lymphocytic infiltrates in case of acute rejection
Time frame: 1 year
Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation
Time frame: 1 year
Immunological and virologic status after renal transplantation
Time frame: 1 year
Evaluation of the switch by raltegravir at the time of renal transplantation
Time frame: 1 year
Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation
Time frame: 1 year
Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation
Time frame: 1 year
Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir
Time frame: 1 year
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 13 Apr 2026.
- Results publication: PubMed 30688008Matignon M, Lelievre JD, Lahiani A, Abbassi K, Desvaux D, Diallo A, Peraldi MN, Taburet AM, Saillard J, Delaugerre C, Costagliola D, Assoumou L, Grimbert P; ANRS 153 TREVE study group. Low incidence of acute rejection within 6 months of kidney transplantation in HIV-infected recipients treated with raltegravir: the Agence Nationale de Recherche sur le Sida et les Hepatites Virales (ANRS) 153 TREVE trial. HIV Med. 2019 Mar;20(3):202-213. doi: 10.1111/hiv.12700. Epub 2019 Jan 27.
- French National Agency for Research on AIDS and viral HepatitisLink 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.
Philippe GRIMBERT, MD principal investigator
CHU Henri-Mondor
Dominique COSTAGLIOLA, PHD study director
INSERM U943
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raltegravir in people with HIV-1 Infection and Chronic Renal Insufficiency, run by ANRS, Emerging Infectious Diseases at 14 sites 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 7 inclusion and 16 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 13 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 14 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of acute clinical renal graft rejection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01453192, which also lists 1 linked publication.
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 13 Apr 2026.