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

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

Age range

35+ years

Sex

All

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)