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

NCT01065207 | Completed

• 1 other identifier: 05-0222
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• to allow the long-term follow-up of the HIV controllers. Epidemiological, clinical, virological, and immunological data will be collected.

Secondary Outcomes (1)

• 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

Study Arms (1)

patient

NO INTERVENTION

Biological: blood test at day one

Interventions

blood test at day one BIOLOGICAL

Epidemiological, clinical, virological, and immunological data will be collected. Clinical events as neoplasia will be collected

patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Covered by French Social Security

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Unknown Facility

Le Kremlin-Bicêtre, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• JP Faller, MD

  CH Belfort

  PRINCIPAL INVESTIGATOR

• Pascal Roblot, PHD

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

• Gilles Beaucaire, MD

  CHU Pointe à Pitre

  PRINCIPAL INVESTIGATOR

• Christine Rouger, MD

  Hôpital Robert Debré REIMS

  PRINCIPAL INVESTIGATOR

• Jean Luc Delassus, MD

  CHI Ballanger Aulnay sous Bois

  PRINCIPAL INVESTIGATOR

• Alain Devidas, MD

  Hopital Gilles De Corbeil Corbeil

  PRINCIPAL INVESTIGATOR

• Louis Bubertet

  Hopital St Louis Paris

  PRINCIPAL INVESTIGATOR

• Michèle Bentata, MD

  Hopital Avicenne BOBIGNY

  PRINCIPAL INVESTIGATOR

• Alexandra Compagnucci, MD

  Hopital Hotel Dieu Paris

  PRINCIPAL INVESTIGATOR

• Philippe Genet, PHD

  Hopital Victore Dupouy Argenteuil

  PRINCIPAL INVESTIGATOR

• Olivier Patey, PHD

  CHI Villeneuve St Goerges

  PRINCIPAL INVESTIGATOR

• Marie Christine Drobacheff, MD

  CHU St Jacques Besancon

  PRINCIPAL INVESTIGATOR

• Helder Gil, MD

  CHU Minjoz Besanson

  PRINCIPAL INVESTIGATOR

• Eric Oksenhendler, PHD

  Hopital St Louis Paris

  PRINCIPAL INVESTIGATOR

• Frédéric Lucht, PHD

  Hopital Bellevue St Etienne

  PRINCIPAL INVESTIGATOR

• Michel Dupon, PHD

  Hopital Pellegrin Bordeaux

  PRINCIPAL INVESTIGATOR

• Jean Luc Schmit, MD

  Hôpital Nord Amiens

  PRINCIPAL INVESTIGATOR

• Daniel Sereni, PHD

  St Louis ¨Paris

  PRINCIPAL INVESTIGATOR

• JP Viard, MD

  Hotel Dieu Paris

  PRINCIPAL INVESTIGATOR

• JP Bru, MD

  CH Annecy

  PRINCIPAL INVESTIGATOR

• JF Delfraissy, PHD

  Le Kremlin Bicetre

  PRINCIPAL INVESTIGATOR

• Gilles Pichancourt

  CH Henri Duffaut Avignon

  PRINCIPAL INVESTIGATOR

• André Pierre Blanc, MD

  CH du payx d'Aix

  PRINCIPAL INVESTIGATOR

• Alain Lafeuillade, MD

  Hopital Chalucet Toulon

  PRINCIPAL INVESTIGATOR

• Christophe Rapp, PHD

  Hopital Inter Armées Bégin St Mandé

  PRINCIPAL INVESTIGATOR

• Pierre De Truchis, MD

  Hopital Raymond Pointcarré Garches

  PRINCIPAL INVESTIGATOR

• Vincent Jeantils, MD

  Hopital Jean Verdier Bondy

  PRINCIPAL INVESTIGATOR

• Daniel Vittecoq, PHD

  Hopital Paul Brousse Villejuif

  PRINCIPAL INVESTIGATOR

• Gilles Pialoux, PHD

  Hopital Tenon Paris

  PRINCIPAL INVESTIGATOR

• Olivier Bouchaud, PHD

  Hopital Avicenne Bobigny

  PRINCIPAL INVESTIGATOR

• Francois Boué, PHD

  Hopital Antoine Béclère Clamart

  PRINCIPAL INVESTIGATOR

• Laurence Weiss, PHD

  HEGP Paris

  PRINCIPAL INVESTIGATOR

• Dominique Salmon Ceron, PHD

  Cochin

  PRINCIPAL INVESTIGATOR

• Olivier Bletry, PHD

  Hopital Foch Suresnes

  PRINCIPAL INVESTIGATOR

• Emmanuel Mortier, MD

  Louis Mourier Paris

  PRINCIPAL INVESTIGATOR

• Alain Sobel, PHD

  Hopital Henri Mondor Créteil

  PRINCIPAL INVESTIGATOR

• Christine Katlama, PHD

  Pitié Salpétrière Paris

  PRINCIPAL INVESTIGATOR

• Anne Simon, MD

  Pitié Salpétrière Paris

  PRINCIPAL INVESTIGATOR

• Pierre Marie Girard, PHD

  St Antoine Paris

  PRINCIPAL INVESTIGATOR

• JM Molina, PHD

  St Louis Paris

  PRINCIPAL INVESTIGATOR

• André Cabié, MD

  Hopital Pierre Zobda Quitman Fort de France

  PRINCIPAL INVESTIGATOR

• JM Chennebault, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Philippe Morlat, PHD

  Hopital St André Bordeaux

  PRINCIPAL INVESTIGATOR

• Pierre Weinbreck, PHD

  CHU Limoges

  PRINCIPAL INVESTIGATOR

• JL Tourraine, PHD

  Hopital Edouard Herriot - Lyon

  PRINCIPAL INVESTIGATOR

• Christian Trépo, PHD

  Hopital Hotel Dieu Lyon

  PRINCIPAL INVESTIGATOR

• Isabelle Poizot Martin, MD

  Ste Marguerite Marseille

  PRINCIPAL INVESTIGATOR

• Sophie Matheron, MD

  Hopital Bichat, Paris

  PRINCIPAL INVESTIGATOR

• François Raffi, PHD

  Hopital Hotel Dieu Nantes

  PRINCIPAL INVESTIGATOR

• Philippe Perré, MD

  CH La Roche sur Yon

  PRINCIPAL INVESTIGATOR

• Pierre Delomonica, PHD

  Hopital l'Archet Nice

  PRINCIPAL INVESTIGATOR

• Eric Rosenthal, PHD

  Hopital l'Archet Nice

  PRINCIPAL INVESTIGATOR

• Christian Michelet, PHD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• David Rey, MD

  CHU Strasbourg

  PRINCIPAL INVESTIGATOR

• JM Besnier, PHD

  Hopital Bretonneau Tours

  PRINCIPAL INVESTIGATOR

• Bruno Marchou, PHD

  CHU Purpan (Toulouse)

  PRINCIPAL INVESTIGATOR

• Renaud Verdon, PHD

  Hopital de la côte de Nacre Caen

  PRINCIPAL INVESTIGATOR

• Christine Jacomet, MD

  Hopital Hotel Dieu Clermont Ferrand

  PRINCIPAL INVESTIGATOR

• Lionel Piroth, MD

  CHU Dijon

  PRINCIPAL INVESTIGATOR

• Pascale Leclercq, MD

  Hopital Albet Michallon Grenoble

  PRINCIPAL INVESTIGATOR

• Yazdan Yazdanpanah, PHD

  Hopital Gustave Dron Tourcoing

  STUDY DIRECTOR

• Thierry May, PHD

  Hopital de Brabois Nancy

  PRINCIPAL INVESTIGATOR

• Francois Caron, PHD

  chu Rouen

  PRINCIPAL INVESTIGATOR

• Patrick Mercié, PHD

  St André Bordeaux

  PRINCIPAL INVESTIGATOR

• Claire Series, PHD

  Hopital Pellegrin Bordeaux

  PRINCIPAL INVESTIGATOR

• Philippe Granier, MD

  CH Bourg en Bresse

  PRINCIPAL INVESTIGATOR

• Marc Gatfosse, MD

  CH rené Arbeltier Coulomniers

  PRINCIPAL INVESTIGATOR

• Patrice Poubeau, MD

  Groupe Hospitalier Sud Reunion St Pierre de la Réunion

  PRINCIPAL INVESTIGATOR

• Agnès Uludag, MD

  Hopital Beaujon Clichy

  PRINCIPAL INVESTIGATOR

• Philippe Arsac, MD

  CHR Orléans

  PRINCIPAL INVESTIGATOR

• Isabelle Delacroix, MD

  CH intercommunal Créteil

  PRINCIPAL INVESTIGATOR

• Vincent Daneluzzi, MD

  CASH Nanterre

  PRINCIPAL INVESTIGATOR

• Elisabeth Rouveix, MD

  Hôpital Ambroise Paré Boulogne

  PRINCIPAL INVESTIGATOR

• Goerges Diab, MD

  CH Noyon

  PRINCIPAL INVESTIGATOR

• Geneviève Berck Wirth

  CH Mulhouse

  PRINCIPAL INVESTIGATOR

• Philippe Romand, MD

  CHI Les hopitaux du Léman Thonon les Bains

  PRINCIPAL INVESTIGATOR

• Laurent Blum, MD

  Hopital René Dubois Pontoise

  PRINCIPAL INVESTIGATOR

• Christophe Michau, MD

  CH St Nazaire

  PRINCIPAL INVESTIGATOR

• Raymond Armero, MD

  CHI Fréjus St Raphaël

  PRINCIPAL INVESTIGATOR

• Bernard Christian, MD

  Hopital Notre Dame de Bon Secours Metz

  PRINCIPAL INVESTIGATOR

• Philippe Muller, MD

  Hopital Beauregard Thionville

  PRINCIPAL INVESTIGATOR

• Henri Jardel, MD

  CH Bretagne Atlantique Vannes

  PRINCIPAL INVESTIGATOR

• Elisabeth Carbonnel, MD

  Hôpital Simone Weil Eaubonne

  PRINCIPAL INVESTIGATOR

• Laurent Hocqueloux, MD

  Hopital La source Orléans

  PRINCIPAL INVESTIGATOR

• Marie Odile Lemaitre, MD

  CH Juvisy sur Orge

  PRINCIPAL INVESTIGATOR

• Patrick Philibert, MD

  Hopital Ambroise Paré Marseille

  PRINCIPAL INVESTIGATOR

• Paul Henry Consigny, MD

  Institut Pasteur Paris

  PRINCIPAL INVESTIGATOR

• JM Ragnaud, PHD

  Hopital Pellegrin Bordeaux

  PRINCIPAL INVESTIGATOR

• Daniel Garipuy, MD

  Hopital Joseph Ducuing Toulouse

  PRINCIPAL INVESTIGATOR

• Beuscart MD Claude

  CHU St Brieuc

  PRINCIPAL INVESTIGATOR

• Leprêtre MD Annie

  Hôpital Simone Veil - Eaubonne

  PRINCIPAL INVESTIGATOR

• Duvivier MD Claudine

  Institut Pasteur Paris

  PRINCIPAL INVESTIGATOR

• Garipuy MD Daniel

  Hôpital Joseph Ducuing Toulouse

  PRINCIPAL INVESTIGATOR

• Aumaitre MD Hugues

  Centre hospitalier de Perpignan

  PRINCIPAL INVESTIGATOR

• Rami MD Agathe

  Lariboisière Paris

  PRINCIPAL INVESTIGATOR

• De Lavassière MD Marc

  CH Général Montauban

  PRINCIPAL INVESTIGATOR

• Miailhes MD Patrick

  Hôpital Croix Rousse Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

FR (1)