Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV

Part of paid clinical trials in Aurora, Colorado.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07871552
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Epigenetic Aging

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL — DRUG
    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 — DRUG
    DOR/ISL (100mg/0.25mg) will be supplied as coformulated tablets to be taken orally once daily.
  • Continue SoC ART — DRUG
    participants will continue to receive standard of care ART

Study Details

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

Key Dates

First listed
Oct 13, 2026
Start date
Oct 30, 2026
Status verified
Oct 2026
Primary completion
Apr 15, 2028
Completion
Oct 15, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group 1
  • Experimental: Group 2
  • Active Comparator: Group 3

Primary Outcome Measure

Biologic aging, as measured by validated epigenetic clocks [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CenterAuroraColorado80045
Kristine Erlandson, MD
[email protected]
303-724-4941
The University of Texas Health Science Center at HoustonHoustonTexas77030
Jordan E Lake, MD, MSc
[email protected]
(713) 500-6759
Arezou S Akha
[email protected]
(713) 500-6500

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical Center· Aurora, COThe University of Texas Health Science Center at Houston· Houston, TX

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