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Clinical Trials/NCT05433987
NCT05433987
Completed
Not Applicable

Study Aiming to Measure the Impact on Immune Activation and Inflammatory Markers of Switching From a Triple Combination Antiretroviral Therapy (cART) to a Long Acting Dual Therapy in HIV-infected Patients

Centre Hospitalier de Cannes Simone Veil1 site in 1 country20 target enrollmentJuly 28, 2022
ConditionsHIV-1-infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV-1-infection
Sponsor
Centre Hospitalier de Cannes Simone Veil
Enrollment
20
Locations
1
Primary Endpoint
Evolution the trajectory of immune activation and inflammatory markers
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients

Detailed Description

Patients meeting the inclusion criteria will be offered to participate to the study. In case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up. Six months after cART change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers

Registry
clinicaltrials.gov
Start Date
July 28, 2022
End Date
November 17, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier de Cannes Simone Veil
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients agreeing to participate to the study and to collect their data
  • HIV-1 infected subjects
  • Patients switching from a stable (at least 6 months) and successful triple cART to a long acting dual cART
  • Patients older than 18 yrs and regularly followed in Cannes and Nice hospitals
  • Patients with a healthcare card

Exclusion Criteria

  • HIV-2 infected subjects
  • Patients not being on successful and stable cART
  • Patients having being treated during acute HIV-infection
  • Patients modifying cART for virological failure
  • Subjects modifying their treatment for another combination than from a triple cART to a dual cART
  • Patients modifying cART during the 6 months of follow-up
  • Patients refusing to participate to the study
  • Patients included in an interventional study during the 6 months of follwo-up
  • Patient under juridical procedure

Outcomes

Primary Outcomes

Evolution the trajectory of immune activation and inflammatory markers

Time Frame: Baseline and 6 months after modiyfying cART

Assess the trajectory of immune activation and inflammatory markers change at 6 month after modifying cART

Secondary Outcomes

  • Prevalence of patients with successful cART(1 month, 3 month, 6 month)

Study Sites (1)

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