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

HIV-1-infection Clinical Trial

— LONGADAPT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05433987
• Other study ID #: CHC-PI-2022-01
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: July 2023

Study information

• Verified date: June 2022
• Source: Centre Hospitalier de Cannes Simone Veil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Cannes Simone Veil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of patients with successful cART	To evaluate prevalence of patients with successful cART (i.e. viral load below 50 copies/ml) 1 month after the switch	1 month, 3 month, 6 month