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HIV drug switch may protect hearts: small study tests doravirine

NCT ID NCT04820933

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

26 people

The number who actually took part.

Started

Mar 2024

Finished

Dec 2025

Lead sponsor

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

18 to 70 years

Sex

Male participants only

Healthy volunteers

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

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

  • University of Texas Southwestern

    Dallas, Texas, 75219, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75219, United States

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