Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV (ANRSCO3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03296202
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Agence Nationale de Recherches contre le SIDA et les hépatites virales (ANRS)
Institut National de la Santé Et de la Recherche Médicale, France
French Ministry of Health through the COREVIH Aquitaine
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are largely available. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects.

The main objective of the cohort is to describe and study the evolution of HIV infection in ART-treated individuals.


Condition or disease
HIV Infections Antiretroviral Agents

Detailed Description:

The survival of people living with HIV (PLHIV) taking antiretroviral therapy (ART) is now close to what is reported in the general population in northern countries. However, PLHIV experience an increased risk of morbidities that the ANRS CO3 Aquitaine Cohort has largely contributed to describe in the last years. Among contributing factors to this excess of morbidity, immune suppression, immune activation, and exposition to cardiovascular and cancer risk factors as well as ageing represent possible intervention targets. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as ART side effects.

Moreover, the global evaluation of health in PLHIV, including psychiatric, neurologic and social determinants and not only biomedical determinants represents one of the public health challenges of the next decade in the field of HIV infection.

The aim of the present study is to study the emerging morbidity occurring during the course of HIV infection in people treated with ART as well as to describe the tolerance and efficacy of new available ART regimens.

The follow-up of patients will be performed according to national guidelines. Demographic, clinical, biological and therapeutic data will be captured at each patient's hospital contact according to a standardized questionnaire.

All events occurring during the course of clinical management will be prospectively registered in the database according to the ICD 10th revision. A biobank will be collected from every consenting PLHIV at inclusion in the cohort and then every two years.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV: The ANRS CO3 Aquitaine Cohort
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
HIV patients
4500 patients infected with HIV-1



Primary Outcome Measures :
  1. Socio-demographic characteristics of people living with the HIV [ Time Frame: Each 12 months from baseline for 4 years (M48) ]

Secondary Outcome Measures :
  1. HIV infection characteristics of people living with the HIV [ Time Frame: Each 12 months from baseline for 4 years (M48) ]
    group of infection, stage of infection, duration since first serology positive, CD4 nadir, last CD4 measurement, CD4 / CD8 ratio

  2. comorbidities of people living with the HIV [ Time Frame: Each 12 months from baseline for 4 years (M48) ]
  3. co-infections of people living with the HIV [ Time Frame: Each 12 months from baseline for 4 years (M48) ]
    Hepatitis B, Hepatitis C, cytomegalovirus infection...

  4. Therapeutics description [ Time Frame: Each 12 months from baseline for 4 years (M48) ]
    naïve / treated status, dosage

  5. virological responses [ Time Frame: Each 12 months from baseline for 4 years (M48) ]

Biospecimen Retention:   Samples With DNA
Blood sampling


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients infected with HIV-1 (PLHIV)
Criteria

Inclusion Criteria:

  • Patients aged over 18 years old.
  • Confirmed HIV infection
  • Signed informed consent

Exclusion Criteria:

  • HIV-2 infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296202


Contacts
Layout table for location contacts
Contact: Fabrice BONNET, Prof (0)5 56 79 58 26 ext +33 fabrice.bonnet@chu-bordeaux.fr
Contact: Olivier LELEUX (0)5 57 57 45 44 ext +33 Olivier.Leleux@u-bordeaux.fr

Locations
Layout table for location information
France
service de médecine interne - CH d'Agen Not yet recruiting
Agen, France, 47923
Contact: Patrick RISPAL, MD       rispalp@ch-agen.fr   
Principal Investigator: Patrick RISPAL, MD         
service de maladies infectieuses - CH de la Côte Basque Recruiting
Bayonne, France, 64109
Contact: Marc-Olivier VAREIL, MD       movareil@ch-cotebasque.fr   
Principal Investigator: Marc-Olivier VAREIL, MD         
service de médecine inter et maladies infectieuses - Hopital Saint André Recruiting
Bordeaux, France, 33075
Contact: Patrick MERCIE, Prof       patrick.mercie@chu-bordeaux.fr   
Principal Investigator: Patrick MERCIE, Prof         
service de médecine interne et maladies infectieuses - Hôpital Saint-André Recruiting
Bordeaux, France, 33075
Contact: Fabrice BONNET, Prof       fabrice.bonnet@chu-bordeaux.fr   
Principal Investigator: Fabrice BONNET, Prof         
service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: MALVY Denis, Prof       denis.malvy@chu-bordeaux.fr   
Principal Investigator: Denis MALVY, Prof         
service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Didier NEAU, Prof       didier.neau@chu-bordeaux.fr   
Principal Investigator: Didier NEAU, Prof         
service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: DUPON Michel, Prof       michel.dupon@chu-bordeaux.fr   
Principal Investigator: DUPON Michel, Prof         
Service D'Urgences Pédiatriques Recruiting
Bordeaux, France
Contact: Camille RUNEL-BELLIARD, MD       camille.runel@chu-bordeaux.fr   
Principal Investigator: Camille RUNEL-BELLIARD, MD         
service de médecine interne et maladies infectieuses - CH de Dax Recruiting
Dax, France, 40107
Contact: Yann GERARD, MD       gerardy@ch-dax.fr   
Principal Investigator: Yann GERARD, MD         
service de médecine interne - CH d'Arcachon Recruiting
La Teste-de-Buch, France, 33260
Contact: Carine COURTAULT, MD       carine.courtault@ch-arcachon.fr   
Principal Investigator: Carine COURTAULT, MD         
service de médecine interne - CH de Libourne Not yet recruiting
Libourne, France, 33505
Contact: Helene FERRAND, MD       helene.ferrand@ch-libourne.fr   
Sub-Investigator: Sten DE WITTE, MD         
Principal Investigator: Helene FERRAND, MD         
service de médecine interne - CH de Mont de Marsan Not yet recruiting
Mont-de-Marsan, France, 40024
Contact: Maud FOISSAC, MD       maud.foissac@ch-mt-marsan.fr   
Principal Investigator: Maud FOISSAC, MD         
service de médecine interne - CH d'Orthez Recruiting
Orthez, France
Contact: Yann GERARD, MD       gerardy@ch-dax.fr   
Principal Investigator: Yann GERARD, MD         
service de médecine interne et maladies infectieuses - CH de Pau Recruiting
Pau, France, 64000
Contact: Eric MONLUN, MD       eric.monlun@ch-pau.fr   
Principal Investigator: Eric MONLUN, MD         
service de médecine interne et maladies infectieuses - CH de Périgueux Recruiting
Perigueux, France, 24019
Contact: Philippe LATASTE, MD       philippe.lataste@ch-perigueux.fr   
Principal Investigator: Philippe LATASTE, MD         
service de médecine interne et maladies infectieuses - Groupe hospitalier Sud Recruiting
Pessac, France
Contact: Jean-François VIALLARD, Prof       jean-francois.viallard@chu-bordeaux.fr   
Sub-Investigator: Jean-Luc PELLEGRIN, Prof         
Principal Investigator: Jean-François VIALLARD, Prof         
service de maladies infecteieuses - CH Saint-Cyr Not yet recruiting
Villeneuve sur Lot, France, 47307
Contact: Isabelle CHOSSAT, MD       isabelle.chossat@ch-stcyr.fr   
Principal Investigator: Isabelle CHOSSAT, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Agence Nationale de Recherches contre le SIDA et les hépatites virales (ANRS)
Institut National de la Santé Et de la Recherche Médicale, France
French Ministry of Health through the COREVIH Aquitaine
Investigators
Layout table for investigator information
Study Chair: Linda WITTKOP, MD, PhD ISPED - CHU de Bordeaux
Principal Investigator: Fabrice BONNET, Prof University Hospital, Bordeaux

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03296202     History of Changes
Other Study ID Numbers: CHUBX 2016/04
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by University Hospital, Bordeaux:
HIV
cohort studies
antiretroviral treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents