Cohort of Patients Naive of Antiretroviral Treatment at Enrollment (COPANA)

• ClinicalTrials.gov Identifier: NCT03137797
• Recruitment Status: Completed
• First Posted: May 3, 2017
• Last Update Posted: May 3, 2017
• Sponsor: ANRS, Emerging Infectious Diseases
• Information provided by (Responsible Party): ANRS, Emerging Infectious Diseases

Study Description

Brief Summary:

The purpose of this study is to evaluate the short, medium and long-term prognosis for newly diagnosed HIV patients.

Condition or disease
HIV Infection

Detailed Description:

The purpose of this study is to evaluate the short, medium and long-term prognosis for newly diagnosed HIV patients.

This study aims to precise the impact of HIV infection treatment on morbidity and mortality, the factors related to treatment response, clinical and biological complications, their consequences, especially lipodystrophy and metabolic abnormalities, associated factors especially genetic, aspects linked to aging.

In addition, the study describes the evolution of patients living conditions and behaviors remotely from their screening, particularly related to sexuality, reproduction, and health inequalities and to study the long-term treatment adherence.

One third of the patients were included in the metabolic disorders module. This module includes additional biological and imaging explorations.

Study Design

• Study Type: Observational
• Actual Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cohort of Patients Naive of Antiretroviral Treatment at Enrollment
• Study Start Date: February 2004
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Patients prognosis at short, medium and long term [ Time Frame: Up to 12 years ]

Secondary Outcome Measures :

1. Antiretroviral treatment impact [ Time Frame: Up to 12 years ]
   therapeutical adherence, factors related with treatment response
2. Aging population [ Time Frame: up to 12 years ]
   Study of caracteristics of the population over 50 years old (quality of life or comorbidities... in questionnaire and autoquestionnaire)
3. Impact of inflammatory markers on antiretroviral treatment [ Time Frame: Up to 12 years ]
   from blood collection: IL-6, sTNF-R1, sTNF-R2, CD14, CRP
4. Socio-economic conditions (sexuality, education, reproduction, health inequalities) [ Time Frame: Up to 12 years ]
   Completed in annual questionnaire and auto-quesitonnaire by the patient and the physician

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients infected with HIV-1, with a recent diagnosis (<1 year before enrollment) and untreated at the time of enrollment, aged 15 or more and agreeing to participate in the cohort.

Criteria

Inclusion Criteria:

• Patients infected with HIV-1, with a recent diagnosis (<1 year before enrollment)
• Untreated at the time of enrollment,
• Aged 15 or more
• Agreeing to participate in the cohort.

Exclusion Criteria:

• Under protection(saving) of justice

Contacts and Locations

Locations

France

Meyer

Kremlin-Bicêtre, France, 94270

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases

Investigators

• Principal Investigator: Laurence Meyer, Professor; Institut National de la Santé Et de la Recherche Médicale, France

More Information

Publications:

Boufassa F, Goujard C, Viard JP, Carlier R, Lefebvre B, Yeni P, Bouchaud O, Capeau J, Meyer L, Vigouroux C; ANRS COPANA Cohort Study Group. Immune deficiency could be an early risk factor for altered insulin sensitivity in antiretroviral-naive HIV-1-infected patients: the ANRS COPANA cohort. Antivir Ther. 2012;17(1):91-100. doi: 10.3851/IMP1916.

Dray-Spira R, Legeai C, Le Den M, Boué F, Lascoux-Combe C, Simon A, May T, Goujard C, Meyer L; ANRS-COPANA Cohort Study Group. Burden of HIV disease and comorbidities on the chances of maintaining employment in the era of sustained combined antiretoviral therapies use. AIDS. 2012 Jan 14;26(2):207-15. doi: 10.1097/QAD.0b013e32834dcf61.

Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.

Krastinova E, Seng R, Yeni P, Viard JP, Vittecoq D, Lascoux-Combe C, Fourn E, Pahlavan G, Delfraissy JF, Goujard C, Meyer L; ANRS PRIMO and COPANA Cohorts. Is clinical practice concordant with the changes in guidelines for antiretroviral therapy initiation during primary and chronic HIV-1 infection? The ANRS PRIMO and COPANA cohorts. PLoS One. 2013 Aug 1;8(8):e71473. doi: 10.1371/journal.pone.0071473. Print 2013. Erratum in: PLoS One. 2013;8(11). doi:10.1371/annotation/aed12a66-9c76-4e49-806b-881a2fe23bba. Goujard, Cecile [added].

Legeai C, Vigouroux C, Souberbielle JC, Bouchaud O, Boufassa F, Bastard JP, Carlier R, Capeau J, Goujard C, Meyer L, Viard JP; ANRS-COPANA Cohort Study Group. Associations between 25-hydroxyvitamin D and immunologic, metabolic, inflammatory markers in treatment-naive HIV-infected persons: the ANRS CO9 "COPANA" cohort study. PLoS One. 2013 Sep 18;8(9):e74868. doi: 10.1371/journal.pone.0074868. eCollection 2013.

Boufassa F, Lechenadec J, Meyer L, Costagliola D, Hunt PW, Pereyra F, Deeks S, Pancino G, Taulera O, Lichterfeld M, Delobel P, Saez-Cirion A, Lambotte O; ANRS CO18 HIV Controllers Cohort; Cascade Collaboration in Eurocoord; SCOPE Cohort; International HIV Controllers Study. Blunted response to combination antiretroviral therapy in HIV elite controllers: an international HIV controller collaboration. PLoS One. 2014 Jan 17;9(1):e85516. doi: 10.1371/journal.pone.0085516. eCollection 2014.

El Khoury P, Ghislain M, Villard EF, Le Goff W, Lascoux-Combe C, Yeni P, Meyer L, Vigouroux C, Goujard C, Guerin M. Plasma cholesterol efflux capacity from human THP-1 macrophages is reduced in HIV-infected patients: impact of HAART. J Lipid Res. 2015 Mar;56(3):692-702. doi: 10.1194/jlr.M054510. Epub 2015 Jan 8.

Ghislain M, Bastard JP, Meyer L, Capeau J, Fellahi S, Gérard L, May T, Simon A, Vigouroux C, Goujard C; ANRS-COPANA Cohort Study Group. Late Antiretroviral Therapy (ART) Initiation Is Associated with Long-Term Persistence of Systemic Inflammation and Metabolic Abnormalities. PLoS One. 2015 Dec 4;10(12):e0144317. doi: 10.1371/journal.pone.0144317. eCollection 2015.

Ploquin MJ, Madec Y, Casrouge A, Huot N, Passaes C, Lécuroux C, Essat A, Boufassa F, Jacquelin B, Jochems SP, Petitjean G, Angin M, Gärtner K, Garcia-Tellez T, Noël N, Booiman T, Boeser-Nunnink BD, Roques P, Saez-Cirion A, Vaslin B, Dereudre-Bosquet N, Barré-Sinoussi F, Ghislain M, Rouzioux C, Lambotte O, Albert ML, Goujard C, Kootstra N, Meyer L, Müller-Trutwin MC. Elevated Basal Pre-infection CXCL10 in Plasma and in the Small Intestine after Infection Are Associated with More Rapid HIV/SIV Disease Onset. PLoS Pathog. 2016 Aug 10;12(8):e1005774. doi: 10.1371/journal.ppat.1005774. eCollection 2016 Aug.

• Responsible Party: ANRS, Emerging Infectious Diseases
• ClinicalTrials.gov Identifier: NCT03137797
• Other Study ID Numbers: ANRS CO9 COPANA
• First Posted: May 3, 2017
• Last Update Posted: May 3, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

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