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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks of treatment with lexiva.

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

diarrhea

influenza

100%

80%

60%

40%

20%

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

0 / 3Eligibility 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.