Actively Recruiting

Age: 18Years +
All Genders
NCT04160455

Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.

Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30

180

Participants Needed

1

Research Sites

1043 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Little is known about autophagy during HIV infection. Recently, two different teams reported important dysfunctions of autophagy in HIV-infected patients despite sustained suppressive antiretroviral therapy. As altered autophagy is strongly linked to cellular senescence and chronic inflammation, two hallmarks of HIV-infected patients despite long-term suppressive antiretroviral therapy, it is important to improve our knowledge in the area. Our main objective is to determine whether all or part of mononuclear cell subpopulations (CD4+ and CD8+ T lymphocytes, and monocytes) exhibit a defect in autophagy function in a cohort of HIV-infected patients who are virologically-controlled (plasma HIV RNA \<50 copies / ml) either spontaneously (i.e. HIV controllers or post-treatment controllers) or after they started antiretroviral therapy at different time points (i.e. at the acute or chronic phases), as compared with a control group (i.e. uninfected healthy blood donors).

CONDITIONS

Official Title

Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Male or female
  • Diagnosed with HIV-1 infection (not HIV-2)
  • Followed at Orleans' Regional Hospital
  • Belongs to one of the defined patient groups/cohorts
  • Provided written consent
  • Cohort A: on suppressive antiretroviral therapy for at least 4 years started during chronic phase, with CD4 count either below 500 (group A1) or above 500 cells/ml (group A2)
  • Cohort B: on suppressive antiretroviral therapy for at least 4 years started within 4 months of acute infection (primary infection)
  • Cohort C: untreated with detectable HIV RNA but indicated to start therapy, diagnosed during primary infection (group C1), or chronic phase with CD4 count above 200 (group C2) or below 200 cells/ml (group C3)
  • Cohort D: undetectable HIV RNA without therapy, either spontaneously or after treatment interruption
Not Eligible

You will not qualify if you...

  • Unable to meet study requirements as judged by investigator
  • Pregnant or lactating women
  • History of inflammatory bowel disease, cancer, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction affecting results
  • Presence of blood clotting abnormalities or unexplained bleeding history
  • Use of oral or injectable anticoagulants (curative or preventive)
  • Protected adults or minors under French Public Health Code
  • Under guardianship or curatorship
  • Not covered by French health insurance
  • Currently participating in another clinical trial evaluating treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Orleans

Orléans, France, 45067

Actively Recruiting

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Research Team

A

Aurélie DESPUJOLS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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