Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

HIV Infection Clinical Trial

— COPANA  

Official title:

Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137797
• Other study ID #: ANRS CO9 COPANA
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: April 28, 2017
• Start date: February 2004
• Est. completion date: June 2016

Study information

• Verified date: April 2017
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
France	Meyer	Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients prognosis at short, medium and long term		Up to 12 years
Secondary	Antiretroviral treatment impact	therapeutical adherence, factors related with treatment response	Up to 12 years
Secondary	Aging population	Study of caracteristics of the population over 50 years old (quality of life or comorbidities... in questionnaire and autoquestionnaire)	up to 12 years
Secondary	Impact of inflammatory markers on antiretroviral treatment	from blood collection: IL-6, sTNF-R1, sTNF-R2, CD14, CRP	Up to 12 years
Secondary	Socio-economic conditions (sexuality, education, reproduction, health inequalities)	Completed in annual questionnaire and auto-quesitonnaire by the patient and the physician	Up to 12 years