Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (NCT04820933) | Clinical Trial Compass
CompletedEarly Phase 1
Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV
United States26 participantsStarted 2024-03-01
Plain-language summary
This research application will explore the impact of the Non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine in the setting of established Nucleoside reverse transcriptase inhibitors (NRTIs) backbone \[Tenofovir alafenamide (TAF) / Emtricitabine (FTC) as a possible therapeutic strategy to minimize the detrimental impact of ART-related toxicities on metabolism and instigators of atherosclerosis. Given the possible favorable role of NNRTI in pathogenesis of HIV-related dyslipidemia and cardiovascular disease (CVD), this research will provide mechanistic insights into HIV pathogenesis and safety data regarding doravirine (DOR). These data may promote DOR as a robust "HDL friendly" and "metabolism friendly", therapeutic agent that may attenuate morbidity in chronic treated HIV infection. Towards this aim, the investigators will study DOR-related effects on HDL (HDL-C levels and function) and ex vivo assays that determine key molecular determinants of atherogenesis.
Who can participate
Age range
18 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared doravirine against integrase inhibitors — both combined with emtricitabine and tenofovir alafenamide — so how do the HIV medications I'm currently being considered for compare to those specific drug combinations in terms of their effects on my cholesterol and heart health?
2The trial measured things like HDL function and foam cell formation, which are linked to cardiovascular risk — given that I have HIV, should my doctor be routinely monitoring these kinds of markers, and does my current treatment plan account for them?
3Since this was an early Phase 1 study that has already completed, the findings are likely preliminary — has my doctor seen any published results from this trial, and do those results influence which antiretroviral regimen they might recommend for me?
4This trial specifically enrolled people with cardiovascular risk factors alongside HIV — if I have any heart disease risk factors like high cholesterol or high blood pressure, does that change which HIV medication my doctor would suggest for me?
5Doravirine is a different class of HIV drug than integrase inhibitors — can my doctor explain the practical differences between those two types of medications and whether one might be a better fit for my specific health situation??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HDL function
Timeframe: 12 weeks post switch of antivirals
2
Monocyte chemotaxis
Timeframe: 12 weeks post switch of antivirals
3
Monocyte derived foam cell formation of monocytes
Timeframe: 12 weeks post switch of antivirals
Trial details
NCT IDNCT04820933
SponsorUniversity of Texas Southwestern Medical Center