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

NCT05433987 | Completed

• 1 other identifier: CHC-PI-2022-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1-infection

Keywords

inflammatory markers; dual therapy; treatment simplification

Outcome Measures

Primary Outcomes (1)

• Evolution the trajectory of immune activation and inflammatory markers

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

  Baseline and 6 months after modiyfying cART

Secondary Outcomes (1)

• Prevalence of patients with successful cART

  1 month, 3 month, 6 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient HIV-1, regularly followed in Cannes and Nice Hospital and for which the doctor has decided to modify the treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Cannes Simone Veil: lead

Study Sites (1)

Nathalie DOUX

Cannes, 06414, France

Location

Study Officials

• Matteo Vassallo, MD

  Centre Hospitalier de Cannes Simone Veil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: July 28, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

FR (1)