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Completed

NCT Number: NCT03137797

Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

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

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meyer

Le Kremlin-Bicêtre, 94270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patients prognosis at short, medium and long term

    Time frame: Up to 12 years

Secondary outcomes

  1. Antiretroviral treatment impact

    Time frame: Up to 12 years

    therapeutical adherence, factors related with treatment response

  2. 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)

  3. Impact of inflammatory markers on antiretroviral treatment

    Time frame: Up to 12 years

    from blood collection: IL-6, sTNF-R1, sTNF-R2, CD14, CRP

  4. 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Acronym: COPANA

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
May 3, 2017
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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