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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-16

Study Completion Date

2026-02-01

Brief Summary

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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

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Detailed Description

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Conditions

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Hiv

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

plasma inflammatory markers

Intervention Type OTHER

Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)

CD4/CD8 ratio

Intervention Type OTHER

Evolution of CD4/CD8 ratio

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

Group Type EXPERIMENTAL

plasma inflammatory markers

Intervention Type OTHER

Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)

CD4/CD8 ratio

Intervention Type OTHER

Evolution of CD4/CD8 ratio

Interventions

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plasma inflammatory markers

Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)

Intervention Type OTHER

CD4/CD8 ratio

Evolution of CD4/CD8 ratio

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No