Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

NCT ID: NCT03137797

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurence Meyer, Professor

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meyer

Le Kremlin-Bicêtre, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22267473 (View on PubMed)

Dray-Spira R, Legeai C, Le Den M, Boue 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.

Reference Type BACKGROUND
PMID: 22008658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23079802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23936509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24058636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24465584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25573889 (View on PubMed)

Ghislain M, Bastard JP, Meyer L, Capeau J, Fellahi S, Gerard 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.

Reference Type BACKGROUND
PMID: 26636578 (View on PubMed)

Ploquin MJ, Madec Y, Casrouge A, Huot N, Passaes C, Lecuroux C, Essat A, Boufassa F, Jacquelin B, Jochems SP, Petitjean G, Angin M, Gartner K, Garcia-Tellez T, Noel N, Booiman T, Boeser-Nunnink BD, Roques P, Saez-Cirion A, Vaslin B, Dereudre-Bosquet N, Barre-Sinoussi F, Ghislain M, Rouzioux C, Lambotte O, Albert ML, Goujard C, Kootstra N, Meyer L, Muller-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.

Reference Type BACKGROUND
PMID: 27509048 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANRS CO9 COPANA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cohort IMEA 070 -Lenacapavir Compassional
NCT06289361 ACTIVE_NOT_RECRUITING