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Protease Inhibitor

Lexiva for Laryngopharyngeal Reflux

Phase 3
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
RFS ≥ 11
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks of treatment with lexiva.
Awards & highlights

Study Summary

This trial will test the efficacy of fosamprenavir/Lexiva as a treatment for laryngopharyngeal reflux (LPR), which causes chronic cough, throat clearing, hoarseness, and dysphagia.

Who is the study for?
This trial is for adults over 18 with moderate to severe LPR, a throat condition causing cough and hoarseness. Participants must have tried acid-reducing meds without success and be confirmed to have LPR by specific tests. It's not for those over 65, pregnant or nursing women, or people with certain GI diseases, past stomach surgeries, suspected cancer in the throat area, or on many other medications.Check my eligibility
What is being tested?
The study is testing Lexiva (an HIV drug) as a potential treatment for LPR by seeing if it can inhibit pepsin—a cause of inflammation in the throat. This will be a 12-week test where half the patients get Lexiva and half get a placebo. They'll measure symptoms before and after using questionnaires and saliva tests.See study design
What are the potential side effects?
While side effects are not detailed here, since Lexiva is an HIV medication being repurposed, common side effects may include gastrointestinal issues like nausea or diarrhea, headaches, fatigue, and possible allergic reactions.

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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My cancer has not returned for at least 11 months.
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I have taken acid reflux medication for 3 months without improvement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 weeks of treatment with lexiva.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks of treatment with lexiva. 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 in Reflux Symptom Index (RSI)
Change in Reflux finding score (RFS)
Secondary outcome measures
Change in salivary pepsin enzyme activity

Side effects data

From 2010 Phase 4 trial • 36 Patients • NCT01010399
11%
hypercholesterolemia
3%
diarrhea
3%
influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Boosted Lexiva With Lovaza

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LexivaExperimental Treatment1 Intervention
Lexiva/fosamprenavir at the FDA approved and manufacturers recommended dose (1,400mg twice daily) for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
standard of care

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,497 Total Patients Enrolled
1 Trials studying Laryngopharyngeal Reflux

Media Library

Lexiva (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04383262 — Phase 3
Laryngopharyngeal Reflux Research Study Groups: Lexiva, Placebo
Laryngopharyngeal Reflux Clinical Trial 2023: Lexiva Highlights & Side Effects. Trial Name: NCT04383262 — Phase 3
Lexiva (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04383262 — Phase 3

Frequently Asked Questions

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

What is the clinical evidence to support Lexiva's efficacy?

"There is one ongoing clinical trial for Lexiva that is currently in Phase 3. Most of the trial sites are located in Milwaukee, Wisconsin, but there are a total of two locations running trials for Lexiva."

Answered by AI

What is the most pressing concern regarding Lexiva's safety profile?

"Given that this is a Phase 3 trial with data supporting efficacy and safety, Lexiva receives a score of 3 for safety."

Answered by AI

Would elderly patients be welcomed in this clinical trial?

"The current study is only enrolling patients aged 18-65, although there are 2 other trials for patients that are under 18 and 4 trials for patients above the age of 65."

Answered by AI

Are people with the qualifying illness able to enroll in this study at this time?

"As can be seen from the date of the last edit on clinicaltrials.gov, this particular trial is no longer recruiting patients. Although this trial is no longer active, there are 6 other trials that patients may participate in."

Answered by AI

How many people are going to be given this medication as part of the trial?

"This study is closed to new participants. The clinical trial was first posted on 1/31/2023 and was most recently updated on 11/3/2022. If you are seeking other studies, there are 5 clinical trials actively recruiting participants with regurgitation, gastric, and 1 study for Lexiva actively enrolling patients."

Answered by AI

What are the ideal candidate requirements for this clinical trial?

"This study is targeting a very specific population: those aged 18-65 who have regurgitation and gastric and who also meet the following conditions: a clinical diagnosis of LPR, an RSI score of 20 or higher, an RFS score of 11 or higher, documented LPR by MII-pH testing (>1 proximal event), failure of 3-month bid PPI therapy, attending laryngology clinic with flexible laryngoscopy and MII-pH testing per routine clinical care (with a minimum of 3 months between clinic visits), the ability to comply with the saliva sample collection, treatment plan"

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Ally Lesnick

Why did patients apply to this trial?

I have had LPR since 2017 and the condition has only gotten worse.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long does screening take?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Lexiva for the Treatment of LPR
Nikki Johnston 2024. "Lexiva for the Treatment of LPR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04383262.
~69 spots leftby Oct 2025
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