Status:
UNKNOWN
Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Hiv
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
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
Key Trial Info
Start Date :
February 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05699785
Start Date
February 16 2023
End Date
February 1 2026
Last Update
March 13 2024
Active Locations (2)
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1
CH Simone VEIL
Cannes, France, 06614
2
CHU Nice
Nice, France