RecruitingNot ApplicableNCT05699785

Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy

Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy (ART) With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy

Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

500 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

HIV

Summary

HIV-infected patients develop comorbidities earlier than the general population. Immune activation with the secretion of pro-inflammatory cytokines would play a major role in the occurrence of these comorbidities. Numerous factors, called risk factors, already identified in the general population and confirmed in patients with HIV virus favor the occurrence of these comorbidities but cannot alone explain the overrepresentation and precocity of these comorbidities in the HIV population. Investigators hypothesize that optimization or simplification with certain classes of antiretrovirals modify the inflammatory response and are predictive factors for the occurrence of comorbidities

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares inflammation levels and rates of health complications in HIV-positive patients who switched to a two-drug antiretroviral regimen versus a three-drug regimen — both using newer, more effective integrase inhibitor-based treatments. **You may be eligible if...** - You are HIV-positive and over 40 years old (or have been on antiretroviral therapy for more than 10 years) - You switched to one of two specific drug regimens (BIC/FTC/TAF or DTG/3TC) within the past 2 years - Your HIV viral load has been undetectable (below 50 copies/mL) for more than 6 months - You do not have chronic hepatitis B **You may NOT be eligible if...** - You take your antiretroviral therapy irregularly (e.g., only 4–5 days a week) - You are pregnant or breastfeeding - You have drug-resistance mutations affecting your current regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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