Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

Completed

• Conditions: HIV Infection

• Registration Number: NCT03137797
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-19
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Study First Posted: 2017-05-03
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients prognosis at short, medium and long term	Up to 12 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Meyer; 🇫🇷 Kremlin-Bicêtre, France