ACTIVE_NOT_RECRUITING

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

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Conditions

HIV I InfectionCardiovascular Risk FactorLipid Metabolism DisordersHIVAntiretroviral therapyCardiovascular disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2024-03-01
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04820933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Cases: Chronically infected and on anti-retroviral therapy with suppressed viremia for at least 3 months (viral RNA \<50 copies per ml)
  3. * 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).
  4. * 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.
  5. * Adequate renal function determined by the Cockcroft-Gault formula for creatinine clearance (\>60 mL/min/1.73 m2
  6. * Able and willing to provide written consent
  1. * • Pregnancy
  2. * Hepatitis; no evidence of acute hepatitis in the prior 30 days
  3. * History of severe renal impairment (eGFR \< 30 ml/min/1.73 m2)
  4. * History of severe or recent cardiac event
  5. * Current alcoholism or IV drug abuse
  6. * Use of systemic immunomodulatory medications (e.g. steroids) within 4 weeks of enrollment
  7. * 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).
  8. * Use of any investigational products within 4 weeks of enrollment
  9. * 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.
  10. * 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.
  11. * 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).

Contacts and Locations

Principal Investigator

Theodoros Kelesidis, MD PHD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75219
United States
University of Texas Southwestern
Dallas, Texas, 75219
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Theodoros Kelesidis, MD PHD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • Antiretroviral therapy
  • Cardiovascular disease

Additional Relevant MeSH Terms

  • HIV I Infection
  • Cardiovascular Risk Factor
  • Lipid Metabolism Disorders