Status:
UNKNOWN
Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge).
Lead Sponsor:
University of Roma La Sapienza
Conditions:
HIV
Eligibility:
All Genders
18-70 years
Brief Summary
The HIV-infected population is aging due to the success of combination antiretroviral therapy, which prolongs survival, as well as the growing number of newly diagnosed cases in adults 50 years old an...
Detailed Description
HIV-infected individuals suffer from an accelerated aging due to the persistent and chronic activation of the immune system that leads to immune exhaustion and accelerated immunosenescence. The succes...
Eligibility Criteria
Inclusion
- HIV-1 infected patients
- aged \> 50 years old
- naive patients receiving doravirine-based regimens both as single drug and as in fixed combination with lamivudine and tenofovir disoproxil fumarate
- experienced patients with persistently undetectable plasma HIV viral load (HIV RNA \< 50 copies/mL) for at least 6 months, who switched from any antiretroviral drug to doravirine-based regimens, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate, because of toxicity, convenience or other reasons.
- estimated creatinine clearance (CrCl) ≥50mL/min.
Exclusion
- previous genotypic testing showing resistance mutations to doravirine
- acute hepatitis, decompensated liver disease, liver cirrhosis
- use of systemic immunosuppressive therapy
Key Trial Info
Start Date :
January 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05202613
Start Date
January 4 2022
End Date
December 1 2022
Last Update
January 21 2022
Active Locations (1)
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1
Department of Public Health and Infectious Diseases
Rome, Italy/RM, Italy, 00185