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
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 <50 copies/mL at screening and less than or equal to 200 copies/mL within 6 months of entry (latter according to clinical care records). Repeat HIV-1 RNA within the screening allowed if needed to verify eligibility.
Able and willing to provide informed consent and undergo study procedures.
HIV-2
Pregnant or nursing, or intent to become pregnant during the study period
Hypersensitivity or other contraindication to DOR or ISL or any of the components of the study product, as determined by the site investigator.
Active AIDS-defining opportunistic infection <30 days prior to entry.
Parallel
Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL
DrugDOR/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
DrugDOR/ISL (100mg/0.25mg) will be supplied as coformulated tablets to be taken orally once daily.
Continue SoC ART
Drugparticipants will continue to receive standard of care ART
Biologic aging, as measured by validated epigenetic clocks
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be reported in years.
Biologic aging, as measured by validated epigenetic clocks
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be reported in years.
Change in biologic aging, as measured by validated epigenetic clocks
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be reported in years.
Change in epigenetic age in participants switching to DOR/ISL from a NRTI-sparing regimen vs. NRTI-containing regimen
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be reported in years.
Change in epigenetic age in participants switching to DOR/ISL from a NRTI-sparing regimen vs. SOC ART
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be reported in years.
Change in epigenetic age in participant switching to DOR/ISL from a NRTI-containing regimen vs. SOC ART
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be reported in years.
Change in pace of aging in participants switching to DOR/ISL from a NRTI-sparing regimen vs. NRTI-containing regimen
This will be estimated from DNA isolated from whole blood collected in a DNA/RNA Shield tube using DNA methylation-based epigenetic clock analysis.
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