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Not Yet Recruiting
NCT07871552
Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV
Conditions: Epigenetic Aging
Sex: All
Ages: 35 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: The University of Texas Health Science Center, Houston
Location: University of Colorado Anschutz Medical Center Aurora Colorado
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
Eligibility Criteria
Inclusion Criteria:
* Living with HIV-1 and on ART for greater than or equal to 2 years (to allow for epigenetic stabilization after ART initiation
* Current ART greater than or equal to 6 months prior to entry. ART must contain 1) FTC or 3TC with TAF or TDF or 2) any NRTI-sparing regimen consisting of greater than or equal to 2 drugs
* HIV-1 RNA \
Source: ClinicalTrials.gov (NCT07871552). StuddyBuddy aggregates publicly available trial information.
