HIV I InfectionEarly Phase 1NCT04820933
Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV
A Early Phase 1 study testing Doravirine 100 Mg in people with HIV I Infection and Cardiovascular Risk Factor, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- HIV I Infection, Cardiovascular Risk Factor, Lipid Metabolism Disorders
- What is being tested?
- Doravirine 100 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2024to 1 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75219
University of Texas Southwestern
Dallas, Texas, 75219
About this study
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.
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.
Read the 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.
- Being tested
- Doravirine 100 Mg
- Keywords
- HIV, Antiretroviral therapy, Cardiovascular disease
- Medical subject headings
- Lipid Metabolism Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doravirine 100 MgDrug
Also called Descovy (200 mg emtricitabine + 10 mg tenofovir alafenamide fumarate)
Doravirine 100 Mg orally dail
| Study group | Role | What they receive |
|---|---|---|
| Doravirine plus emtricitabine and tenofovir alafenamide fumarate | Experimental | PIFELTRO (doravirine) 100 mg tablet one daily for 3 months Descovy (200 mg emtricitabine + 10 mg tenofovir alafenamide fumarate) tablet one daily for 3 months Receives: Drug: Doravirine 100 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL function
Primary outcome (instigator of atherosclerosis). This is a measure of the lipid peroxide content of HDL per specific amount of HDL relative to the measure of this value in a pooled healthy control (normalized ratio; no units).
Measured: 12 weeks post switch of antivirals
Monocyte chemotaxis
Primary outcome (instigator of atherosclerosis). This is a measure of the ability of isolated blood monocytes to migrate through a trans endothelial layer in an ex vivo model of atherogenesis. Units are % of monocytes that migrated (% chemotaxis).
Measured: 12 weeks post switch of antivirals
Monocyte derived foam cell formation of monocytes
Primary outcome (instigator of atherosclerosis). This is a measure of the ability of isolated blood monocytes to take up lipids and form foam cells in an ex vivo model of atherogenesis. Units are % of monocytes that became foam cells (% Monocyte derived foam cell formation).
Measured: 12 weeks post switch of antivirals
Secondary outcomes (1)
Total cholesterol
Secondary outcome (instigator of atherosclerosis). Units are mg/dl.
Measured: 12 weeks post switch of antivirals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Mar 2024
- Primary completion1 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Theodoros Kelesidis, University of Texas Southwestern Medical Center
- Investigators
- Theodoros Kelesidis, MD PHD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820933
- Sponsor's protocol ID
- MISP# 60720 ; STU-2023-0724
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04820933
- Acronym / sponsor ID
- MISP# 60720 ; STU-2023-0724
- Keywords
- HIV, Antiretroviral therapy, Cardiovascular disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doravirine plus emtricitabine and tenofovir alafenamide fumarate | Experimental | Drug: Doravirine 100 MgPIFELTRO (doravirine) 100 mg tablet one daily for 3 months Descovy (200 mg emtricitabine + 10 mg tenofovir alafenamide fumarate) tablet one daily for 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doravirine 100 MgAlso: Descovy (200 mg emtricitabine + 10 mg tenofovir alafenamide fumarate)Doravirine 100 Mg orally dail | Drug | Doravirine plus emtricitabine and tenofovir alafenamide fumarate |
Primary outcome
HDL function
Time frame: 12 weeks post switch of antivirals
Primary outcome (instigator of atherosclerosis). This is a measure of the lipid peroxide content of HDL per specific amount of HDL relative to the measure of this value in a pooled healthy control (normalized ratio; no units).
Monocyte chemotaxis
Time frame: 12 weeks post switch of antivirals
Primary outcome (instigator of atherosclerosis). This is a measure of the ability of isolated blood monocytes to migrate through a trans endothelial layer in an ex vivo model of atherogenesis. Units are % of monocytes that migrated (% chemotaxis).
Monocyte derived foam cell formation of monocytes
Time frame: 12 weeks post switch of antivirals
Primary outcome (instigator of atherosclerosis). This is a measure of the ability of isolated blood monocytes to take up lipids and form foam cells in an ex vivo model of atherogenesis. Units are % of monocytes that became foam cells (% Monocyte derived foam cell formation).
1 secondary outcome
Total cholesterol
Time frame: 12 weeks post switch of antivirals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodoros Kelesidis, MD PHD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Doravirine 100 Mg in people with HIV I Infection and Cardiovascular Risk Factor, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL function (time frame: 12 weeks post switch of antivirals). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.