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Non-nucleoside Reverse Transcriptase Inhibitor

Doravirine for HIV-Associated Weight Gain

Phase 4
Waitlist Available
Research Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Currently, on a BIC (bictegravir), DTG (dolutegravir), or RAL (raltegravir) +TAF/FTC (or TAF/3TC) regimen with ≥48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry.
Must not have
Historical or current evidence of major mutations associated with any NNRTI resistance
Prior exposure to single-dose nevirapine for the prevention of parent-to-child transmission of HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 0, weeks 4, 12, 24, and 48
Awards & highlights

Summary

This trial is testing if changing HIV medications to doravirine or switching drug combinations can help patients who have gained weight on their current treatment. The study focuses on people with HIV who have experienced significant weight gain. Doravirine works by blocking a different part of the virus, which might help reduce weight gain and improve overall health. Doravirine is an alternative treatment option for individuals who do not tolerate efavirenz.

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.
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.
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 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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tests show major mutations linked to NNRTI resistance.
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I have taken nevirapine once to prevent passing HIV to my child.
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I plan to have weight loss surgery or make major diet or exercise changes soon.
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I have been diagnosed with osteoporosis or osteopenia.
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I haven't been hospitalized or needed serious treatment in the last 30 days.
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My HIV has specific mutations (K65R/E/N or M184V/I).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Occurrence of Grade ≥3 AEs or >10% reduction in CrCl as estimated by the CKD-EPI equation
Occurrence of confirmed plasma HIV-1 RNA >200 copies/mL
Occurrence of premature discontinuation of study treatment

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV infection include non-nucleoside reverse transcriptase inhibitors (NNRTIs) like Doravirine, nucleoside reverse transcriptase inhibitors (NRTIs), protease inhibitors (PIs), and integrase strand transfer inhibitors (INSTIs). NNRTIs, such as Doravirine, work by binding to and inhibiting the reverse transcriptase enzyme, which is crucial for the HIV virus to replicate its genetic material. NRTIs mimic the natural nucleotides used by reverse transcriptase, causing premature termination of the viral DNA chain. PIs inhibit the protease enzyme, preventing the virus from maturing and becoming infectious. INSTIs block the integrase enzyme, which is necessary for the viral DNA to integrate into the host cell's genome. These treatments are vital for HIV patients as they reduce viral load, improve immune function, and decrease the risk of HIV-related complications and transmission.
Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial.

Find a Location

Who is running the clinical trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsLead Sponsor
99 Previous Clinical Trials
73,350 Total Patients Enrolled
AIDS Clinical Trials GroupLead Sponsor
100 Previous Clinical Trials
73,401 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,311 Previous Clinical Trials
5,626,474 Total Patients Enrolled

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
~0 spots leftby Oct 2024