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Patients Infected With HIV Since More Than 10 Years With a Plasma Viral RNA <400 Copies / mL in the Absence of Any Treatment: Study Mechanisms Involved in Controlling the Infection

NCT ID: NCT01065207

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-03-31

Brief Summary

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The investigators have previously described a limited group of HIV-1-infected patients, we called HIV controllers (HIC), who have been infected for more than 10 years, in whom viral replication is spontaneously controlled without any treatment. These patients are defined according to virological criteria: more than 90% of the quantifications of plasma viral load should be less than 400 RNA copies/mL. The purpose of the ANRS EP36 study was to characterize these patients.

Detailed Description

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To study the virological and immunological features of these patients, a consortium of research teams has been set up. Several results were obtained (cf publications) : HIC are infected with replication-competent virus, HIV infects HIC CD4 T cells ex vivo but the CD8 T cells fully control this viral replication. This study led to set up a national observatory of the HICs. This observatory, set up from May 2006 to May 2008, has allowed to identify and include 86 HIC patients in France (about one hundred had been reported by the ANRS centers). When a patient is included, clinical data are collected and a biologic collection set up which can be used in genomic studies. The main characteristics of the patients included in the observatory are a median age at the diagnosis of HIV infection of 29 years (range 1-49), a median age at inclusion of 45 years \[19-78\], 42% are women, 87% are caucasians. The median year of HIV diagnosis is 1989 (1983-1999), so a median of 18 years of known HIV infection. The CD4 median between 1986 and 2008 is 762 CD4/mm3 \[IQR:589-962\], 3% of the 1368 measures are ≤ 350 /mm3; 23% patients have a CD4 T cell count \< 500/mm3 and 6% \< 350/mm3 at the inclusion consultation. The CD4 slope on this period shows a slow decrease estimated to -13 \[-15,-11\] CD4/mm3 per year. Between 1989 and 2007, 2% of the viral loads measured were ≥ 1000 RNA copies/mL. The viral load at inclusion is \> 400 RNA copies/mL in 4%. Median viral DNA at the inclusion in the observatory is 1, 75 \[1, 44-2, 07\] log copies/millions PBMC.

The transformation of the observatory in a cohort CO 18 has several goals. The first one is to allow the long-term follow-up of the HIV controllers. Epidemiological, clinical, virological, and immunological data will be collected. The outcome of these patients is a major question: some patients could loose their HIC status either because of a drop in their CD4 T cell counts to a level below 200/mm3 without major viral replication or because viral replication becomes detectable. To understand the mechanisms involved in the control of the viral replication in HIC implies to study the patients in whom the viral control is lost and to compare them to the HIC in whom the control is preserved. Therefore it is of major importance to follow the patients now included in the observatory during a prolonged time. To increase the frequency of loss of control, the patients in whom the virus is controlled for at least 5 years but for less than 10 years will be included to increase the diversity of the HICs. Clinical events as neoplasias will be collected. The genomic studies will be continued with the benefits of new inclusions and european collaborations will be developed. The question of the quality-of-life of the patients HIC will be studied.

Conditions

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HIV Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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patient

Group Type NO_INTERVENTION

blood test at day one

Intervention Type BIOLOGICAL

Epidemiological, clinical, virological, and immunological data will be collected.

Clinical events as neoplasia will be collected

Interventions

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blood test at day one

Epidemiological, clinical, virological, and immunological data will be collected.

Clinical events as neoplasia will be collected

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* able to give written consent
* who have been infected for more than 5 years
* not treated by ARV
* HIV positive serology
* Covered by French Social Security

Exclusion Criteria

* Non compliance with the criteria of inclusion
* Pregnancy (inclusion can be postponed)
* Covered by French Social Security
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JP Faller, MD

Role: PRINCIPAL_INVESTIGATOR

CH Belfort

Pascal Roblot, PHD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Gilles Beaucaire, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Pointe à Pitre

Christine Rouger, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Robert Debré REIMS

Jean Luc Delassus, MD

Role: PRINCIPAL_INVESTIGATOR

CHI Ballanger Aulnay sous Bois

Alain Devidas, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Gilles De Corbeil Corbeil

Louis Bubertet

Role: PRINCIPAL_INVESTIGATOR

Hopital St Louis Paris

Michèle Bentata, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Avicenne BOBIGNY

Alexandra Compagnucci, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Hotel Dieu Paris

Philippe Genet, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Victore Dupouy Argenteuil

Olivier Patey, PHD

Role: PRINCIPAL_INVESTIGATOR

CHI Villeneuve St Goerges

Marie Christine Drobacheff, MD

Role: PRINCIPAL_INVESTIGATOR

CHU St Jacques Besancon

Helder Gil, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Minjoz Besanson

Eric Oksenhendler, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital St Louis Paris

Frédéric Lucht, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Bellevue St Etienne

Michel Dupon, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pellegrin Bordeaux

Jean Luc Schmit, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Nord Amiens

Daniel Sereni, PHD

Role: PRINCIPAL_INVESTIGATOR

St Louis ¨Paris

JP Viard, MD

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Paris

JP Bru, MD

Role: PRINCIPAL_INVESTIGATOR

CH Annecy

JF Delfraissy, PHD

Role: PRINCIPAL_INVESTIGATOR

Le Kremlin Bicetre

Gilles Pichancourt

Role: PRINCIPAL_INVESTIGATOR

CH Henri Duffaut Avignon

André Pierre Blanc, MD

Role: PRINCIPAL_INVESTIGATOR

CH du payx d'Aix

Alain Lafeuillade, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Chalucet Toulon

Christophe Rapp, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Inter Armées Bégin St Mandé

Pierre De Truchis, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Raymond Pointcarré Garches

Vincent Jeantils, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Jean Verdier Bondy

Daniel Vittecoq, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Paul Brousse Villejuif

Gilles Pialoux, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Tenon Paris

Olivier Bouchaud, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Avicenne Bobigny

Francois Boué, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Antoine Béclère Clamart

Laurence Weiss, PHD

Role: PRINCIPAL_INVESTIGATOR

HEGP Paris

Dominique Salmon Ceron, PHD

Role: PRINCIPAL_INVESTIGATOR

Cochin

Olivier Bletry, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch Suresnes

Emmanuel Mortier, MD

Role: PRINCIPAL_INVESTIGATOR

Louis Mourier Paris

Alain Sobel, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Henri Mondor Créteil

Christine Katlama, PHD

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpétrière Paris

Anne Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpétrière Paris

Pierre Marie Girard, PHD

Role: PRINCIPAL_INVESTIGATOR

St Antoine Paris

JM Molina, PHD

Role: PRINCIPAL_INVESTIGATOR

St Louis Paris

André Cabié, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pierre Zobda Quitman Fort de France

JM Chennebault, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Philippe Morlat, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital St André Bordeaux

Pierre Weinbreck, PHD

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges

JL Tourraine, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot - Lyon

Christian Trépo, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Hotel Dieu Lyon

Isabelle Poizot Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Ste Marguerite Marseille

Sophie Matheron, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Bichat, Paris

François Raffi, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Hotel Dieu Nantes

Philippe Perré, MD

Role: PRINCIPAL_INVESTIGATOR

CH La Roche sur Yon

Pierre Delomonica, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital l'Archet Nice

Eric Rosenthal, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital l'Archet Nice

Christian Michelet, PHD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

David Rey, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Strasbourg

JM Besnier, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Bretonneau Tours

Bruno Marchou, PHD

Role: PRINCIPAL_INVESTIGATOR

CHU Purpan (Toulouse)

Renaud Verdon, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital de la côte de Nacre Caen

Christine Jacomet, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Hotel Dieu Clermont Ferrand

Lionel Piroth, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon

Pascale Leclercq, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Albet Michallon Grenoble

Yazdan Yazdanpanah, PHD

Role: STUDY_DIRECTOR

Hopital Gustave Dron Tourcoing

Thierry May, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital de Brabois Nancy

Francois Caron, PHD

Role: PRINCIPAL_INVESTIGATOR

chu Rouen

Patrick Mercié, PHD

Role: PRINCIPAL_INVESTIGATOR

St André Bordeaux

Claire Series, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pellegrin Bordeaux

Philippe Granier, MD

Role: PRINCIPAL_INVESTIGATOR

CH Bourg en Bresse

Marc Gatfosse, MD

Role: PRINCIPAL_INVESTIGATOR

CH rené Arbeltier Coulomniers

Patrice Poubeau, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Sud Reunion St Pierre de la Réunion

Agnès Uludag, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Beaujon Clichy

Philippe Arsac, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans

Isabelle Delacroix, MD

Role: PRINCIPAL_INVESTIGATOR

CH intercommunal Créteil

Vincent Daneluzzi, MD

Role: PRINCIPAL_INVESTIGATOR

CASH Nanterre

Elisabeth Rouveix, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Ambroise Paré Boulogne

Goerges Diab, MD

Role: PRINCIPAL_INVESTIGATOR

CH Noyon

Geneviève Berck Wirth

Role: PRINCIPAL_INVESTIGATOR

CH Mulhouse

Philippe Romand, MD

Role: PRINCIPAL_INVESTIGATOR

CHI Les hopitaux du Léman Thonon les Bains

Laurent Blum, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital René Dubois Pontoise

Christophe Michau, MD

Role: PRINCIPAL_INVESTIGATOR

CH St Nazaire

Raymond Armero, MD

Role: PRINCIPAL_INVESTIGATOR

CHI Fréjus St Raphaël

Bernard Christian, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Notre Dame de Bon Secours Metz

Philippe Muller, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Beauregard Thionville

Henri Jardel, MD

Role: PRINCIPAL_INVESTIGATOR

CH Bretagne Atlantique Vannes

Elisabeth Carbonnel, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Simone Weil Eaubonne

Laurent Hocqueloux, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital La source Orléans

Marie Odile Lemaitre, MD

Role: PRINCIPAL_INVESTIGATOR

CH Juvisy sur Orge

Patrick Philibert, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Ambroise Paré Marseille

Paul Henry Consigny, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur Paris

JM Ragnaud, PHD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pellegrin Bordeaux

Daniel Garipuy, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Joseph Ducuing Toulouse

Beuscart MD Claude

Role: PRINCIPAL_INVESTIGATOR

CHU St Brieuc

Leprêtre MD Annie

Role: PRINCIPAL_INVESTIGATOR

Hôpital Simone Veil - Eaubonne

Duvivier MD Claudine

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur Paris

Garipuy MD Daniel

Role: PRINCIPAL_INVESTIGATOR

Hôpital Joseph Ducuing Toulouse

Aumaitre MD Hugues

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de Perpignan

Rami MD Agathe

Role: PRINCIPAL_INVESTIGATOR

Lariboisière Paris

De Lavassière MD Marc

Role: PRINCIPAL_INVESTIGATOR

CH Général Montauban

Miailhes MD Patrick

Role: PRINCIPAL_INVESTIGATOR

Hôpital Croix Rousse Lyon

Locations

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Le Kremlin-Bicêtre, , France

Site Status

Countries

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France

Other Identifiers

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05-0222

Identifier Type: -

Identifier Source: org_study_id