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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
Conditions: Hiv
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 500
Sponsor: Centre Hospitalier Universitaire de Nice
Location: France
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 infectionAge > 40 years or adults with more than 10 years of antiretroviral therapySwitching to BIC/FTC/TAF or DTG/3TC or DTG+3TC within the last 2 yearsPlasma HIV-1 RNA viral load < 50 copies/ml for more than 6 monthsAbsence of chronic hepatitis B infectionAbsence of genotype mutations on Dolutegravir (DTG) or Bictegravir (BIC) or tenofovir alafenamide TAFDaily use of antiretroviral therapyEffective contraception for women of childbearing potential will be requestedSigned informed consentEnrollment in a Social Security planExclusion Criteria:Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week)Pregnancy or breastfeedingVulnerable 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 codeOpportunistic infections during curative treatmentHIV-2 infectionActive hepatitis CRefusal to participateWithdrawal of informed consent by the patient
Source: ClinicalTrials.gov (NCT05699785). StuddyBuddy aggregates publicly available trial information.