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

Hiv Clinical Trial

— COLLATERAL 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699785
• Other study ID #: 22-PP-04
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Jacques Durant
• Phone: 04.92.03.97.11
• Email: durant.j[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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)
• CD4/CD8 ratio
Evolution of CD4/CD8 ratio

Locations

Country	Name	City	State
France	CH Simone VEIL	Cannes
France	CHU Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Virological failure rate (year 1)	Virological failure rate (plasma HIV-1 RNA viral load > 50 copies/ml on two consecutive measurements)	One year after baseline
Secondary	residual viremia rate (year 1)	Evolution of the residual viremia rate (detected or quantifiable plasma HIV-1 RNA viral load < 50 copies/ml)	One year after baseline
Secondary	Virological failure rate (year 2)	Virological failure rate (plasma HIV-1 RNA viral load > 50 copies/ml on two consecutive measurements)	two years after baseline
Secondary	Residual viremia rate (year 2)	Evolution of the residual viremia rate (detected or quantifiable plasma HIV-1 RNA viral load < 50 copies/ml)	two years after baseline
Secondary	Virological failure rate (year 3)	Virological failure rate (plasma HIV-1 RNA viral load > 50 copies/ml on two consecutive measurements)	three years after baseline
Secondary	Residuak viremia rate (year 3)	Evolution of the residual viremia rate (detected or quantifiable plasma HIV-1 RNA viral load < 50 copies/ml)	3 years after baseline
Secondary	Prevalence of neuropsychiatric events at 1 year	To analyze the evolution at 1 year of the prevalence of neuropsychiatric events (including sleep disorders, anxiety, depression) between the two groups from the questionnaires.	1 year after baseline
Secondary	Prevalence of neuropsychiatric events at 2 years	To analyze the evolution at 2 years of the prevalence of neuropsychiatric events (including sleep disorders, anxiety, depression) between the two groups from the questionnaires.	2 years after baseline
Secondary	Prevalence of neuropsychiatric events at 3 years	To analyze the evolution at 2 years of the prevalence of neuropsychiatric events (including sleep disorders, anxiety, depression) between the two groups from the questionnaires.	3 years after baseline
Secondary	changes in antiretroviral therapy (year 1)	Analyze the 1-year change in the prevalence of changes in antiretroviral therapy and the reasons for changes between the two groups based on questionnaires	1 year after baseline
Secondary	changes in antiretroviral therapy (year 2)	Analyze the 2-years change in the prevalence of changes in antiretroviral therapy and the reasons for changes between the two groups based on questionnaires	2 years after baseline
Secondary	changes in antiretroviral therapy (year 3)	Analyze the 3-years change in the prevalence of changes in antiretroviral therapy and the reasons for changes between the two groups based on questionnaires	3 years after baseline
Secondary	Evolution of intracellular markers (CD8/CD38, HLA-DR) (year 1)	To analyze the evolution of intracellular markers (CD8/CD38, HLA-DR) at 1 year between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged = 65 years)	1 year after baseline
Secondary	plasma markers assay (year 1)	Analyze the evolution of plasma markers at 1 year between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged = 65 years)	1 year after baseline
Secondary	plasma markers assay (year 2)	Analyze the evolution of plasma markers at 2 years between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged = 65 years)	2 years after baseline
Secondary	plasma markers assay (year 3)	Analyze the evolution of plasma markers at 3 years between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged = 65 years)	3 years after baseline
Secondary	risk factors for immune hyper activation	Analyze and compare risk factors for immune hyper activation (age, CD4 nadir<200 cells/mm3, AIDS stage, residual viremia, archived M184V/I resistance...) in each group	3 years after baseline
Secondary	immune activation markers assays and identification of comorbidities	Correlate immune activation markers with the occurrence of comorbidities	3 years after baseline
Secondary	comorbidities (year 1)	Measurement of the true incidence of major 11 comorbidities (Depression, Cardiovascular, Osteoporosis, Non-AIDS related cancers, Metabolic syndrome, Cognitive disorders, Chronic renal failure , proximal renal tubulopathy, Hepatic fibrosis, Chronic Obstructive Pulmonary Disease, Osteoarthritis) at 1 year	1 year after baseline
Secondary	comorbidities (year 2)	Measurement of the true incidence of major 11 comorbidities (Depression, Cardiovascular, Osteoporosis, Non-AIDS related cancers, Metabolic syndrome, Cognitive disorders, Chronic renal failure , proximal renal tubulopathy, Hepatic fibrosis, Chronic Obstructive Pulmonary Disease, Osteoarthritis) at 2 years	2 years after baseline
Secondary	comorbidities (year 3)	Measurement of the true incidence of major 11 comorbidities (Depression, Cardiovascular, Osteoporosis, Non-AIDS related cancers, Metabolic syndrome, Cognitive disorders, Chronic renal failure , proximal renal tubulopathy, Hepatic fibrosis, Chronic Obstructive Pulmonary Disease, Osteoarthritis) at 3 years	3 years after baseline
Secondary	Onset of new comorbidity	Measure the time to onset of new comorbidity(ies) in each group.	3 years after baseline
Secondary	patient profiles	Describe patient profiles at risk for comorbidities based on different inflammatory biomarkers	3 years after baseline
Secondary	individualized and computerized care plan	Establish an individualized and computerized care plan for the patient after evaluation of the risk factors (according to the profiles) to detect the occurrence or aggravation of comorbidities	3 years after baseline