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 (ANRS CO18)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01065207
First received: February 8, 2010
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
HIV Infection
Biological: blood test at day one

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: ANRS HIV CONTROLLERS NATIONAL OBSERVATORY

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • to allow the long-term follow-up of the HIV controllers. Epidemiological, clinical, virological, and immunological data will be collected. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: March 2009
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: patient Biological: blood test at day one

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

Clinical events as neoplasia will be collected


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065207

Locations
France
Kremlin Bicêtre, France
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: 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
Study Director: Yazdan Yazdanpanah, PHD Hopital Gustave Dron Tourcoing
Principal Investigator: 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 CH 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
  More Information

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT01065207     History of Changes
Other Study ID Numbers: 05-0222
Study First Received: February 8, 2010
Last Updated: December 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014