Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Plasma inflammatory markers
timeFrame: 3 years after baseline
measure: CD4/CD8 ratio
timeFrame: 3 years after baseline
Secondary outcomes:
measure: Virological failure rate (year 1)
timeFrame: One year after baseline
measure: residual viremia rate (year 1)
timeFrame: One year after baseline
measure: Virological failure rate (year 2)
timeFrame: two years after baseline
measure: Residual viremia rate (year 2)
timeFrame: two years after baseline
measure: Virological failure rate (year 3)
timeFrame: three years after baseline
measure: Residuak viremia rate (year 3)
timeFrame: 3 years after baseline
measure: Prevalence of neuropsychiatric events at 1 year
timeFrame: 1 year after baseline
measure: Prevalence of neuropsychiatric events at 2 years
timeFrame: 2 years after baseline
measure: Prevalence of neuropsychiatric events at 3 years
timeFrame: 3 years after baseline
measure: changes in antiretroviral therapy (year 1)
timeFrame: 1 year after baseline
measure: changes in antiretroviral therapy (year 2)
timeFrame: 2 years after baseline
measure: changes in antiretroviral therapy (year 3)
timeFrame: 3 years after baseline
measure: Evolution of intracellular markers (CD8/CD38, HLA-DR) (year 1)
timeFrame: 1 year after baseline
measure: plasma markers assay (year 1)
timeFrame: 1 year after baseline
measure: plasma markers assay (year 2)
timeFrame: 2 years after baseline
measure: plasma markers assay (year 3)
timeFrame: 3 years after baseline
measure: risk factors for immune hyper activation
timeFrame: 3 years after baseline
measure: immune activation markers assays and identification of comorbidities
timeFrame: 3 years after baseline
measure: comorbidities (year 1)
timeFrame: 1 year after baseline
measure: comorbidities (year 2)
timeFrame: 2 years after baseline
measure: comorbidities (year 3)
timeFrame: 3 years after baseline
measure: Onset of new comorbidity
timeFrame: 3 years after baseline
measure: patient profiles
timeFrame: 3 years after baseline
measure: individualized and computerized care plan
timeFrame: 3 years after baseline
Other outcomes:
Locations:
city: Cannes
country: France
facility: CH Simone VEIL
city: Nice
country: France
facility: CHU Nice
Study officials:
affiliation: durant.j@chu-nice.fr
name: Jacques Durant
role: PRINCIPAL_INVESTIGATOR
References: