Epigenetic AgingPhase 2DELILAHNCT07871552
Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV
A Phase 2 study testing Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL, Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL and Continue SoC ART in people with Epigenetic Aging, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Epigenetic Aging
- What is being tested?
- Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL, Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL and Continue SoC ART
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2026to 15 Oct 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Active malignancy (exclusive of basal/squamous cell skin cancer)
- Active Hepatitis B Virus
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- Chronic Hepatitis C Virus
- Other concomitant chronic inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), in the opinion of the site investigator
- Advanced liver disease (Childs-Pugh Class B or C)
- Any condition, therapy, laboratory abnormality or other circumstance that the site investigator feels may confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate.
- Concomitant (current or <45 days of entry) use of any investigational compound or device.
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate Cytochrome P450 3A (CYP3A) inducers from <45 days prior to entry through the study treatment period
- Documented or known virologic resistance to DOR, as demonstrated by any of the following DOR resistance substitutions in RT: Valine106Alanine/Methionine (V106A/M), Valine108 Isoleucine (V108I), tyrosine 188 leucine (Y188L), Histidine 221 tyrosine (H221Y), Proline 225 histidine (P225H), Phenylalanine 227 cysteine, leucine, or valine (F227C/L/V), Methionine 230 isoleucine/leucine (M230I/L), Leucine 2341 isoleucine (L234I), Proline 236 leucine (P236L) or Tyrosine 318 phenylalanine (Y318F)
- Concern for risk of virologic failure with switch to DOR, based on participant history and in the opinion of the site investigator
- Use of agents containing glucagon-like peptide-1 receptor agonists during the study or within 24 W of entry
- Any of the following laboratory abnormalities:
- Alkaline phosphatase (AP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of normal (ULN).
- Calculated creatinine clearance less than or equal to 30 mL/min, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation -Cluster of Differentiation 4 (CD4+) T cell count <50 cells/mm3
- Absolute lymphocyte count <0.650 × 109 cells/L
- Hemoglobin (Hb) <9 or <10 g/dL for persons assigned female or male sex at birth, respectively
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045
Kristine Erlandson, MD, 303-724-4941, KRISTINE.ERLANDSON@CUANSCHUTZ.EDU
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jordan E Lake, MD, MSc, 713-500-6767, Jordan.E.Lake@uth.tmc.edu
Arezou S Akha, 713-500-5541, Arezou.SadighiAkha@uth.tmc.edu
About this study
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
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
- Conditions
- Epigenetic Aging
- Being tested
- Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL, Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL, Continue SoC ART
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISLDrug
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/ISLDrug
DOR/ISL (100mg/0.25mg) will be supplied as coformulated tablets to be taken orally once daily.
Continue SoC ARTDrug
participants will continue to receive standard of care ART
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL |
| Group 2 | Experimental | Not described Receives: Drug: Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL |
| Group 3 | Active comparator | Not described Receives: Drug: Continue SoC ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Week 24
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.
Measured: Baseline, week 24
Secondary outcomes (9)
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.
Measured: Baseline, week 24
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.
Measured: Baseline, week 24
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.
Measured: Baseline, week 24
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.
Measured: Baseline, week 24
Change in pace of aging in participants switching to DOR/ISL from a NRTI-sparing regimen vs. SOC ART
This will be estimated from DNA isolated from whole blood collected in a DNA/RNA Shield tube using DNA methylation-based epigenetic clock analysis.
Measured: Baseline, week 24
Change in pace of aging in participants switching to DOR/ISL from a NRTI-containing regimen vs. SOC ART
This will be estimated from DNA isolated from whole blood collected in a DNA/RNA Shield tube using DNA methylation-based epigenetic clock analysis.
Measured: Baseline, week 24
Pace of aging in participants continuing SoC ART
This will be estimated from DNA isolated from whole blood collected in a DNA/RNA Shield tube using DNA methylation-based epigenetic clock analysis.
Measured: from baseline to week 24
Change in epigenetic age in participants continuing SoC ART
Epigenetic age will be estimated using DNA methylation-based epigenetic clock analysis. Epigenetic age will be measured in years.
Measured: Baseline, week 24
DOR/ISL tolerability as assessed by number of adverse events reported
Measured: from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epigenetic AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Elizabeth Lake, The University of Texas Health Science Center, Houston
- Investigators
- Jordan E Lake, MD, MSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871552
- Sponsor's protocol ID
- HSC-MS-26-0659
- Acronym
- DELILAH
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No