NCT04820933

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

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.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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, elvitegravir, bictegravir) in the setting of TAF backbone in HIV infected persons with dyslipidemia. Aim 2: To evaluate the relative in vivo impact of DOR on ex vivo atherogenesis (monocyte-derived foam cell efflux and chemotaxis) compared to integrase inhibitors (raltegravir, dolutegravir, elvitegravir, bictegravir) in the setting of TAF backbone.

Conditions

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

Interventions

Type	Name	Description
DRUG	Doravirine 100 Mg	Doravirine 100 Mg orally dail

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2021-03-29
• Last updated: 2026-01-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study