Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03137797

Acronym

COPANA

Enrollment

800

Registered

2017-05-03

Start date

2004-02-29

Completion date

2016-06-30

Last updated

2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patients prognosis at short, medium and long term	Up to 12 years

Secondary

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

Countries

France

Outcome results