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OpenTrials
Completed

NCT Number: NCT05433987

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

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

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nathalie DOUX

Cannes, 06414, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Prevalence of patients with successful cART

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cannes Simone Veil

Other

Registry information

Official study 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

Acronym: LONGADAPT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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