Comparing doravirine and integrase inhibitors for HIV treatment
A Switch Clinical Trial of Antiretrovirals to Compare the Impact of Doravirine Versus Integrase Inhibitors With Backbone of Emtricitabine and Tenofovir Alafenamide on Instigators of Atherosclerosis in Persons With Chronic Treated HIV.
This study is testing if doravirine can be a better option than integrase inhibitors for people with HIV who have cholesterol issues, by looking at its effects on heart health over three months.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT04820933 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of doravirine, a non-nucleoside reverse transcriptase inhibitor, compared to integrase inhibitors in HIV-infected individuals who are on a stable antiretroviral therapy regimen. The research focuses on evaluating doravirine's impact on lipid metabolism and cardiovascular risk factors, particularly in patients with dyslipidemia. Participants will be monitored for changes in HDL function and atherogenesis over a three-month period. The study aims to provide insights into the safety and efficacy of doravirine as a potentially more favorable treatment option for managing HIV-related metabolic issues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic HIV infection, stable on antiretroviral therapy, and experiencing dyslipidemia.
Not a fit: Patients who are not on stable antiretroviral therapy or do not have dyslipidemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for HIV patients, particularly those with lipid metabolism disorders and cardiovascular risks.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of doravirine and integrase inhibitors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Dallas, Texas and 1 other locations
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Theodoros Kelesidis, MD PHD — University of Texas Southwestern Medical Center
- Study coordinator: Theodoros Kelesidis, MD, PHD
- Email: Theodoros.Kelesidis@UTSouthwestern.edu
- Phone: 31087304828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.