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Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV
Sponsor: The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to quantify biologic aging (using validated epigenetic clocks) as downstream indicators of Long Interspersed Nuclear Element-1 (LINE-1) retrotransposon activity before and after switch to doravirine (DOR)/Islatravir (ISL) , to estimate whether effects of DOR/ISL on biologic aging vary by entry antiretroviral therapy (ART) regimen, and relative to continued standard of care (SoC) ART and to obtain the tolerability (adverse event profile) associated with switch to DOR/ISL relative to continued SoC ART
Official title: A Pilot, Randomized, Open-Label Trial of the Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10-30
Completion Date
2028-10-15
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL
DOR/ISL (100mg/0.25mg) will be supplied as coformulated tablets to be taken orally once daily.
Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL
DOR/ISL (100mg/0.25mg) will be supplied as coformulated tablets to be taken orally once daily.
Continue SoC ART
participants will continue to receive standard of care ART
Locations (2)
University of Colorado Anschutz Medical Center
Aurora, Colorado, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States