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HIV Patients' kidney transplants: new study tracks rejection risk

NCT ID NCT01453192

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 27 HIV-positive people with kidney failure who received a kidney transplant. All were on a three-drug HIV treatment including Raltegravir. The goal was to see how many had graft rejection within 6 months, using blood tests and kidney biopsies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

27 people

The number who actually took part.

Start date

Dec 2011

Finished

Nov 2015

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic renal insufficiency HIV-1-infection

Contacts and locations

Locations

  • CHRU Lille, Service de néphrologie

    Lille, 59037, France

  • CHU De Caen, Service de Néphrologie Hémodialyse

    Caen, 14033, France

  • CHU de Nantes, Service de Néphrologie et Immunologie Clinique

    Nantes, 44093, France

  • Hopital Saint Louis, Service de Néphrologie

    Paris, 75010, France

  • Hôpital Bretonneau, Service de Néphrologie

    Tours, 37044, France

  • Hôpital Foch, Service de Néphrologie Transplantation

    Suresnes, 92151, France

  • Hôpital Henri Mondor, Service de Néphrologie Transplantation

    Créteil, 94010, France

  • Hôpital Kremlin Bicêtre, Service de Néphrologie

    Le Kremlin-Bicêtre, 94275, France

  • Hôpital Necker, Service de Néphrologie adulte

    Paris, 75743, France

  • Hôpital Pasteur, Service de Néphrologie - Transplantation

    Nice, 06002, France

  • Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse

    Bordeaux, 33076, France

  • Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation

    Toulouse, 31059, France

  • Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale

    Paris, 75970, France

  • Hôpital civil, Service de Néphrologie et Transplantation

    Strasbourg, 67091, France

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