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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

Active Not RecruitingNA

Sponsor: Centre Hospitalier Universitaire de Nice

Conditions: Hiv

Interventions: plasma inflammatory markers, CD4/CD8 ratio

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

Cannes, France
Nice, France