HIV drug switch may protect hearts: small study tests doravirine
NCT ID NCT04820933
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed early-phase trial tested whether switching HIV medications to doravirine (with emtricitabine and tenofovir alafenamide) could improve cholesterol and reduce early signs of artery hardening compared to staying on integrase inhibitors. Twenty-six adults with well-controlled HIV and high cholesterol took part. The study measured blood markers linked to heart disease risk, not actual heart events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Doravirine 100 mg (with emtricitabine and tenofovir alafenamide)
- What this could lead to
- If successful, this could show that doravirine is a better option for people with HIV to lower their risk of heart disease and improve cholesterol levels.
- What could go wrong
- This is a very small, early-phase study with only 26 participants, so results may not apply to everyone. It looked at lab markers, not actual heart attacks, so real-world benefits are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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26 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years of age or older * Cases: Chronically infected and on anti-retroviral therapy with suppressed viremia for at least 3 months (viral RNA \<50 copies per ml) * On stable antiretroviral therapy for \>6 months with Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg; E/C/F/TAF) 2) Biktarvy (bictegravir 50 mg/ emtricitabine 200 mg/tenofovir alafenamide 25 mg; B/F/TAF). * Dyslipidemia (Defined based on use of lipid lowering medications or abnormal baseline lipids (total cholesterol, triglycerides, high density lipoprotein): Rationale: Enrolling participants with dyslipidemia will determine whether switching from TAF/FTC/integrase inhibitor regimen to TAF/FTC/doravirine regimen will directly improve the lipids over 3 months within the same participant. * Adequate renal function determined by the Cockcroft-Gault formula for creatinine clearance (\>60 mL/min/1.73 m2 * Able and willing to provide written consent Exclusion Criteria: * • Pregnancy * Hepatitis; no evidence of acute hepatitis in the prior 30 days * History of severe renal impairment (eGFR \< 30 ml/min/1.73 m2) * History of severe or recent cardiac event * Current alcoholism or IV drug abuse * Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of enrollment * Anemia precluding safe donation of blood (For men, anemia is typically defined as hemoglobin level of less than 13.5 gram/100 ml and in women as hemoglobin of less than 12.0 gram/100 ml). * Use of any investigational products within 4 weeks of enrollment * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease. * Subjects who are on medications that are strong inducers of CYP3A (as these may decrease the efficacy of Stribild or Genvoya). Examples include phenobarbital, phenytoin, carbamazepine, and rifampin. * Subjects who are on medications that are cleared by CYP3A and that may be toxic with elevated drug levels (examples include Cisapride, ergotamine, Pimozide, Lurasidone, Lovastatin, and Simvastatin).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas Southwestern
Dallas, Texas, 75219, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75219, United States
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