What is the mechanism of action of this treatment?

Laryngopharyngeal Reflux (LPR) is commonly treated with proton pump inhibitors (PPIs) that reduce gastric acid production, but these do not prevent reflux events and are often ineffective for LPR. This is because pepsin, an enzyme responsible for laryngeal inflammation, remains active even in non-acidic environments. Treatments like Fosamprenavir, which inhibit pepsin activity, are being studied for their potential to directly target the cause of LPR symptoms. This matters for LPR patients as it could provide a more effective treatment option, especially for those who do not respond to traditional acid-suppressive therapies.

What side effects are associated with this type of intervention?

Common treatments for Laryngopharyngeal Reflux (LPR) include proton pump inhibitors (PPIs) and pepsin inhibitors like Fosamprenavir. PPIs, which reduce gastric acid production, can cause side effects such as headache, diarrhea, constipation, nausea, and potential long-term risks like vitamin B12 deficiency and bone fractures. Fosamprenavir, an HIV protease inhibitor repurposed for LPR, may have side effects including rash, nausea, vomiting, diarrhea, and increased liver enzymes. As with any medication, it is important to discuss potential side effects with a healthcare provider.

What prior FDA approvals exist?

Currently, there are no FDA-approved medical therapies specifically for the treatment of Laryngopharyngeal Reflux (LPR). Proton pump inhibitors (PPIs) are often prescribed, but they are not effective for LPR. Ongoing research is exploring the repurposing of HIV inhibitors, such as Fosamprenavir, which inhibit pepsin activity and show promise for treating LPR.

What other types of research exist?

Promising novel alternatives to Fosamprenavir for Laryngopharyngeal Reflux (LPR) treatment include: 1) Repurposed HIV inhibitors that target pepsin, as they have shown potential in preclinical studies. 2) New formulations of proton pump inhibitors (PPIs) that may offer improved efficacy for LPR patients. 3) Pepsin-specific inhibitors currently under investigation, which directly target the enzyme responsible for laryngeal inflammation. Patients should discuss these options with their healthcare provider to determine the most appropriate treatment based on the latest research and individual health needs.

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Protease Inhibitor

Lexiva for Laryngopharyngeal Reflux

Phase 2

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

Must not have

Currently being treated with another investigational medical device and/or drug

Nasopharyngeal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12-week post-treatment.

Summary

This trial is testing Lexiva, an HIV drug, to help patients with moderate/severe LPR who haven't responded to other treatments. Lexiva works by blocking pepsin, which causes throat inflammation. The goal is to see if this drug can reduce LPR symptoms.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently participating in another clinical trial.

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I have cancer in the upper part of my throat behind the nose.

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I have had surgery to prevent acid reflux.

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I might have esophageal cancer.

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I have had surgery on my stomach or esophagus.

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I have had surgery on my neck or voice box.

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I am taking five or more medications for different health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12-week post-treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12-week post-treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12-week post-treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Daily Symptom Reflux Diary (DRSD)

Change in Reflux Symptom Index (RSI)

Secondary study objectives

Change in salivary pepsin enzyme activity

Other study objectives

Change in Reflux Finding (RFS)

Change in Reflux Sign Assessment (RSA)

Change in Reflux Symptom Scale (RSS).

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral Fosamprenavir-Sodium Alginate (FOS-SA)Experimental Treatment1 Intervention

FOS- SA: 1,400 mg fosamprenavir calcium and 24.5 mg sodium alginate, b.i.d. (AM/PM) for 12 weeks

Group II: PlaceboPlacebo Group1 Intervention

Sodium Alginate: 1,399 mg microcrystalline cellulose and 24.5 mg sodium alginate b.i.d (AM/PM) for 12 weeks.

0 / 10Eligibility criteria met

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

Laryngopharyngeal Reflux (LPR) is commonly treated with proton pump inhibitors (PPIs) that reduce gastric acid production, but these do not prevent reflux events and are often ineffective for LPR. This is because pepsin, an enzyme responsible for laryngeal inflammation, remains active even in non-acidic environments. Treatments like Fosamprenavir, which inhibit pepsin activity, are being studied for their potential to directly target the cause of LPR symptoms. This matters for LPR patients as it could provide a more effective treatment option, especially for those who do not respond to traditional acid-suppressive therapies.