NCT05699785

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hiv

Interventions

Type	Name	Description
OTHER	plasma inflammatory markers	Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)
OTHER	CD4/CD8 ratio	Evolution of CD4/CD8 ratio

Timeline

• Start date: 2023-02-16
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-01-26
• Last updated: 2024-03-13

Locations

2 sites across 1 country: France