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NOT YET RECRUITING
NCT07871552
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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