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

NCT05699785 | Recruiting

• 1 other identifier: 22-PP-04
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Plasma inflammatory markers

  To measure the evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB) over 3 years between the 2 groups.

  3 years after baseline

• CD4/CD8 ratio

  To measure the evolution of CD4/CD8 ratio over 3 years between the 2 groups. A CD4/CD8 ratio is considered normal if it is greater than 0.75. Immune hyperactivation occurs when the ratio is below 0.75

  3 years after baseline

Secondary Outcomes (24)

• Virological failure rate (year 1)

  One year after baseline

• residual viremia rate (year 1)

  One year after baseline

• Virological failure rate (year 2)

  two years after baseline

• Residual viremia rate (year 2)

  two years after baseline

• Virological failure rate (year 3)

  three years after baseline

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

plasma inflammatory markers OTHER

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

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

CD4/CD8 ratio OTHER

Evolution of CD4/CD8 ratio

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CH Simone VEIL

Cannes, 06614, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

CD4-CD8 Ratio

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

CD4 Lymphocyte Count; Lymphocyte Count; Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Immune System Phenomena

Study Officials

• Jacques Durant

  durant.j@chu-nice.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Durant

CONTACT

04.92.03.97.11; durant.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 26, 2023
• Study Start: February 16, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

FR (2)