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

April 28, 2017 updated by: ANRS, Emerging Infectious Diseases
The purpose of this study is to evaluate the short, medium and long-term prognosis for newly diagnosed HIV patients.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Kremlin-Bicêtre, France, 94270
        • Meyer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients prognosis at short, medium and long term
Time Frame: Up to 12 years
Up to 12 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiretroviral treatment impact
Time Frame: Up to 12 years
therapeutical adherence, factors related with treatment response
Up to 12 years
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)
up to 12 years
Impact of inflammatory markers on antiretroviral treatment
Time Frame: Up to 12 years
from blood collection: IL-6, sTNF-R1, sTNF-R2, CD14, CRP
Up to 12 years
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
Up to 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS CO9 COPANA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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