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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05433987

Acronym

LONGADAPT

Enrollment

Registered

2022-06-27

Start date

2022-07-28

Completion date

2023-11-17

Last updated

2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

Keywords

inflammatory markers, dual therapy, treatment simplification

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results