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Not yet recruitingNCT07871552DELILAHUpdated Oct 23, 2026

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

A Phase 2 interventional study of Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL and Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL in Epigenetic Aging, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 2 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Supportive care

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Epigenetic Aging

Keywords

  • HIV
03

In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Browse The University of Texas Health Science Center, Houston studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group 1

    Drug: Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL

  • Experimental
    Group 2

    Drug: Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL

  • Active comparator
    Group 3

    Drug: Continue SoC ART

Interventions

  • DrugSwitch 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.

  • DrugSwitch 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.

  • DrugContinue SoC ART

    participants will continue to receive standard of care ART

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Week 24

  3. 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.

    Time frame: Baseline, week 24

Secondary outcomes

  1. 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.

    Time frame: Baseline, week 24

  2. 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.

    Time frame: Baseline, week 24

  3. 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.

    Time frame: Baseline, week 24

  4. 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.

    Time frame: Baseline, week 24

  5. 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.

    Time frame: Baseline, week 24

  6. 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.

    Time frame: Baseline, week 24

  7. 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.

    Time frame: from baseline to week 24

  8. 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.

    Time frame: Baseline, week 24

  9. DOR/ISL tolerability as assessed by number of adverse events reported

    Time frame: from baseline to week 24

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 2 updates
  1. Oct 23, 2026
    Minor edits only
    + 1 other change: contact details
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871552
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Jordan Elizabeth Lake (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Apr 15, 2028 (estimated)
Completion
Oct 15, 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Jordan E Lake, MD, MSc
Contact
Jordan.E.Lake@uth.tmc.edu
713-500-6767
Arezou S Akha
Contact
Arezou.SadighiAkha@uth.tmc.edu
713-500-5541
Jordan E Lake, MD, MSc
principal investigator · The University of Texas Health Science Center, Houston

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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