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Non-nucleoside reverse transcriptase inhibitor

Doravirine for HIV

Phase < 1

Recruiting

Led By Theodoros Kelesidis, MD PHD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks post switch of antivirals

Awards & highlights

Study Summary

This trial will explore if an HIV drug, doravirine, can help reduce the negative effects of other HIV drugs on metabolism and heart disease. It may help improve HDL levels and function and reduce risk of heart disease.

Who is the study for?

Adults over 18 with chronic, treated HIV and suppressed viremia for at least 3 months can join. They must have dyslipidemia (abnormal lipids or on lipid-lowering meds) and good kidney function. Participants should be on a stable antiretroviral therapy regimen with Genvoya or Biktarvy for more than six months.Check my eligibility

What is being tested?

The trial is testing Doravirine's effects on cholesterol levels and molecular factors linked to heart disease in people with HIV. It compares the switch from an integrase inhibitor-based regimen to one including Doravirine, alongside standard HIV medications TAF/FTC.See study design

What are the potential side effects?

Doravirine may cause side effects like rash, nausea, diarrhea, headache, fatigue, abnormal dreams, insomnia and changes in liver enzymes. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been on stable HIV treatment with Genvoya or Biktarvy for over 6 months.

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I've been on stable HIV treatment with Genvoya or Biktarvy for over 6 months.

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My kidneys are working well, as shown by tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks post switch of antivirals

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks post switch of antivirals

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post switch of antivirals for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HDL function

Monocyte chemotaxis

Monocyte derived foam cell formation of monocytes

Secondary outcome measures

Total cholesterol

Trial Design

1Treatment groups

Experimental Treatment

Group I: Doravirine plus emtricitabine and tenofovir alafenamide fumarateExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,779 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,974 Total Patients Enrolled

University of California, Los AngelesLead Sponsor

1,529 Previous Clinical Trials

10,277,831 Total Patients Enrolled

Media Library

Doravirine (Non-nucleoside reverse transcriptase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04820933 — Phase < 1

HIV Research Study Groups: Doravirine plus emtricitabine and tenofovir alafenamide fumarate

HIV Clinical Trial 2023: Doravirine Highlights & Side Effects. Trial Name: NCT04820933 — Phase < 1

Doravirine (Non-nucleoside reverse transcriptase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04820933 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the standard treatments that Doravirine plus emtricitabine and tenofovir alafenamide fumarate are used in combination with?

"This antiviral medication, which is a combination of doravirine, emtricitabine, and tenofovir alafenamide fumarate, is most often used to treat patients that have no prior experience with pharmacotherapy. Additionally, it can be used to treat human immunodeficiency virus type 1 (hiv-1) in patients that have not developed a resistance to darunavir."

Answered by AI

If an elderly person wanted to participate in this trial, would they be allowed to?

"The age restriction for this clinical trial is that all participants must be over 18 but under 70 years old."

Answered by AI

Who meets the qualifications to join this clinical trial?

"Eligible patients for this trial will have lipid metabolism disorders and be between 18 and 70 years old. There are only 20 spots available for this study."

Answered by AI

Is the Doravirine clinical trial the first of its kind?

"At present, there are 116 ongoing clinical trials researching Doravirine plus emtricitabine and tenofovir alafenamide fumarate with 28 trials in Phase 3. While the majority of the clinical trials for Doravirine plus emtricitabine and tenofovir alafenamide fumarate are located in Boylston, Massachusetts, there are 1776 locations running studies for Doravirine plus emtricitabine and tenofovir alafenamide fumarate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Theodoros Kelesidis 2024. "Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04820933.