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Non-nucleoside Reverse Transcriptase Inhibitor

Doravirine for HIV-Associated Weight Gain

Phase 4
Recruiting
Research Sponsored by AIDS Clinical Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NOTE A: Participants who did not start TAF at the same time as they started an INSTI will be eligible if they started TAF/FTC (or TAF/3TC) ≥48 weeks prior to study entry.
Ability to acquire NRTIs (TAF/FTC or TAF/3TC, and TDF/FTC or TDF/3TC) and INSTI through usual care for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 0, weeks 4, 12, 24, and 48
Awards & highlights

Study Summary

This trial will assess whether people with HIV who have experienced significant weight gain after starting treatment with an integrase strand transfer inhibitor (INSTI) plus tenofovir alafenamide/emtricitabine (TAF/FTC) or TAF/3TC (lamivudine) can either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication).

Who is the study for?
This trial is for adults with HIV who have experienced significant weight gain after starting an INSTI+TAF/FTC or TAF/3TC regimen. They must have been on this treatment for at least 48 weeks, have a BMI of ≥27.5 kg/m2, and show stable viral suppression with no major mutations associated with drug resistance.Check my eligibility
What is being tested?
The study tests if switching to doravirine (a non-nucleoside reverse transcriptase inhibitor) from an INSTI-based regimen can reduce or stabilize weight within a year. It also examines changes in body composition, metabolic health, bone health, and the maintenance of HIV suppression.See study design
What are the potential side effects?
Potential side effects may include typical reactions to antiretroviral therapy such as nausea, headaches, fatigue, possible liver enzyme elevations, and rare but serious risks like lactic acidosis or severe liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I started TAF/FTC or TAF/3TC at least 48 weeks before joining the study.
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I can get the required HIV medications for the study's duration.
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I've been on a specific HIV treatment regimen for at least 48 weeks.
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I switched my HIV medication within the same class more than 24 weeks ago.
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I have a confirmed HIV-1 diagnosis.
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I gained over 10% of my weight without a clear reason after starting or changing to INSTI-based ART.
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My HIV-1 levels have been undetectable for at least the past year.
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I have confirmed HIV-1 infection.
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I've been on a specific HIV treatment regimen for at least 48 weeks.
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I can get the required HIV medications for the study's duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 0, weeks 4, 12, 24, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 0, weeks 4, 12, 24, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change (percent) in body weight (kg) from entry to week 48
Secondary outcome measures
Change (absolute) in fasting cardiometabolic parameters (glucose, insulin, HOMA-IR, triglycerides, LDL, HDL) from entry to weeks 24 and 48
Change (absolute) in waist circumference from entry to weeks 24 and 48
Change (percent) in DEXA hip and lumbar spine bone mineral density from entry to week 48
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: DOR 100 mg + TDF/FTC (or TDF/3TC, depending on location)Experimental Treatment3 Interventions
By mouth daily with or without food
Group II: DOR 100 mg + TAF/FTC (or TAF/3TC, depending on location)Experimental Treatment3 Interventions
By mouth daily with or without food
Group III: Continuation of entry INSTI+TAF/FTC (or TAF/3TC)Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Integrase strand transfer inhibitors
2020
N/A
~120
Tenofovir alafenamide/emtricitabine
2020
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AIDS Clinical Trials GroupLead Sponsor
100 Previous Clinical Trials
73,465 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,265 Previous Clinical Trials
5,483,830 Total Patients Enrolled
John KoetheStudy ChairVanderbilt University Medical Center

Media Library

Doravirine (Non-nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04636437 — Phase 4
Human Immunodeficiency Virus Infection Research Study Groups: DOR 100 mg + TAF/FTC (or TAF/3TC, depending on location), DOR 100 mg + TDF/FTC (or TDF/3TC, depending on location), Continuation of entry INSTI+TAF/FTC (or TAF/3TC)
Human Immunodeficiency Virus Infection Clinical Trial 2023: Doravirine Highlights & Side Effects. Trial Name: NCT04636437 — Phase 4
Doravirine (Non-nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04636437 — Phase 4
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT04636437 — Phase 4

Frequently Asked Questions

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

Are recruitment efforts currently underway for this medical exploration?

"This medical trial is currently in the recruitment process and has been since May 20th 2021, with its last update occurring on February 22nd 2022."

Answered by AI

What is the upper limit for participants in this experiment?

"In order to run this clinical trial, 222 eligible individuals are required. People can join the study at Houston AIDS Research Team CRS (31473) in Texas or Harbor-UCLA CRS (603) in California."

Answered by AI

Are there documented accounts of further research into Integrase strand transfer inhibitors?

"Presently, there are 139 clinical trials taking place for Integrase strand transfer inhibitors with 40 of them in the late stages. While Boylston, Massachusetts is a major hub for this research, other 1959 sites across the country are also running studies on Integrase strand transfer inhibitors."

Answered by AI

What medical condition typically warrants treatment with Integrase strand transfer inhibitors?

"Integrase strand transfer inhibitors are frequently prescribed to treat HIV infections, however they can also prove effective in preventing transmission and suppressing viral loads when used with patients who have not developed doravirine resistance-associated mutations."

Answered by AI

In what number of places is this trial currently being conducted?

"This research project is being conducted at 23 clinical trial sites, with Houston AIDS Research Team CRS (31473) in Houston, Texas; Harbor-UCLA CRS (603) in Torrance, California; and Case CRS (2501) Cleveland, Ohio amongst them."

Answered by AI

What potential risks do Integrase strand transfer inhibitors pose to individuals?

"There is a wealth of evidence confirming integrase strand transfer inhibitors' safety, thus garnering it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Washington AIDS CRS (1401)
Alabama CRS (31788)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I started on biktarvy in beginning diagnosis March 2020 I was 150 pounds with low VL of 3000 I went up to 183 pounds before switching to Cabenuva almost a year ago and now I’m at 165 and I don’t gain rapidly anymore! The biktarvy put weight on my upper body stomach and chest.
PatientReceived 2+ prior treatments
~38 spots leftby Oct 2024