Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy (COLLATERAL 2)

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Hiv

Treatments: Other: CD4/CD8 ratio; Other: plasma inflammatory markers

Study type: Interventional

Funder types: Other

Identifiers

NCT05699785

22-PP-04

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 infection
• Age > 40 years or adults with more than 10 years of antiretroviral therapy
• Switching to BIC/FTC/TAF or DTG/3TC or DTG+3TC within the last 2 years
• Plasma HIV-1 RNA viral load < 50 copies/ml for more than 6 months
• Absence of chronic hepatitis B infection
• Absence of genotype mutations on Dolutegravir (DTG) or Bictegravir (BIC) or tenofovir alafenamide TAF
• Daily use of antiretroviral therapy
• Effective contraception for women of childbearing potential will be requested
• Signed informed consent
• Enrollment in a Social Security plan

Exclusion criteria

• Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week)
• Pregnancy or breastfeeding
• Vulnerable persons according to article L.1121-6 of the public health code Persons unable to give consent according to article L.1121-8 of the public health code
• Opportunistic infections during curative treatment
• HIV-2 infection
• Active hepatitis C
• Refusal to participate
• Withdrawal of informed consent by the patient

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

patients on antiretroviral therapy with second generation anti-integrase drugs in triple therapy

Experimental group

Treatment:

Other: plasma inflammatory markers

Other: CD4/CD8 ratio

patients on antiretroviral therapy with second generation anti-integrase drugs in dual therapy

Experimental group

Treatment:

Other: plasma inflammatory markers

Other: CD4/CD8 ratio