Immune Activation Markers in HIV-infected Patients Switching to Long Acting Dual Therapy

Completed

• Conditions: HIV-1-infection

• Registration Number: NCT05433987
• Lead Sponsor: Centre Hospitalier de Cannes Simone Veil

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

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-27
• Study Start: 2022-07-28
• Primary Completion: 2023-11-17
• Study Completion: 2023-11-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution the trajectory of immune activation and inflammatory markers	Baseline and 6 months after modiyfying cART	Assess the trajectory of immune activation and inflammatory markers change at 6 month after modifying cART

Secondary Outcome Measures

Name	Time	Method
Prevalence of patients with successful cART	1 month, 3 month, 6 month	To evaluate prevalence of patients with successful cART (i.e. viral load below 50 copies/ml) 1 month after the switch

Trial Locations

Locations (1)

Nathalie DOUX; 🇫🇷 Cannes, France