Status:
ACTIVE_NOT_RECRUITING
Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV I Infection
Cardiovascular Risk Factor
Eligibility:
MALE
18-70 years
Phase:
EARLY_PHASE1
Brief 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 (NR...
Detailed Description
Aim 1: To evaluate the relative in vivo impact of DOR on independent measures of HDL function (antioxidant function, cholesterol efflux) compared to integrase inhibitors (raltegravir, dolutegravir, el...
Eligibility Criteria
Inclusion
- 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
- • 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).
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04820933
Start Date
March 1 2024
End Date
August 1 2026
Last Update
October 14 2025
Active Locations (2)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75219
2
University of Texas Southwestern
Dallas, Texas, United States, 75219