Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Mar 24, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called doravirine to see how it works compared to other HIV treatments when used alongside two established drugs, emtricitabine and tenofovir alafenamide. The goal is to find out if doravirine can help reduce issues related to cholesterol and heart health that some people with HIV experience due to their medications. Researchers hope that doravirine might be better for managing cholesterol levels and overall metabolism, which could lead to better health outcomes for people living with HIV.

To participate in this trial, you need to be at least 18 years old, currently taking HIV treatment that keeps the virus under control, and have been on stable medication for at least six months. You should also have some issues with cholesterol levels. If you join the study, you will switch your current treatment to include doravirine for three months, and researchers will monitor how your cholesterol and other health markers change. It's important to know that certain health conditions, including severe kidney problems or recent heart issues, may make you ineligible for this study. If you're interested, you can discuss this opportunity with your healthcare provider to see if it might be a good fit for you.

Gender

MALE

Eligibility criteria

• 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).