Fosamprenavir for Laryngopharyngeal Reflux symptoms
Official title: A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy of Oral Fosamprenavir for Laryngopharyngeal Reflux
Run by Medical College of Wisconsin · NCT04383262 · Data updated 2026-11-12
This study tests whether the HIV drug fosamprenavir can help people with laryngopharyngeal reflux see if their throat symptoms improve.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | October 1, 2028 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT04383262 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with documented LPR who have failed at least 3 months of PPI therapy and meet specified diagnostic criteria.
✕Probably not a fit
Participants who do not respond to the treatment or experience adverse effects may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this phase 2 trial, adults with laryngopharyngeal reflux are randomly assigned to receive fosamprenavir or placebo for 12 weeks in a double-blind setup. The study uses objective testing and symptom diaries to measure changes in reflux-related throat symptoms. Eligibility requires prior PPI failure, specific diagnostic criteria, and ongoing participation in clinical care with regular laryngology assessments. Safety monitoring includes hepatic function and lab assessments, with adherence supported by electronic diary entries. Results will inform whether fosamprenavir can reduce LPR symptoms and be safe in this population.
Why it matters
Potential benefit: If successful, participants may experience reduced throat symptoms and improved quality of life related to LPR.
How similar studies have gone: Prior preclinical work suggests pepsin inhibition could help LPR, with limited clinical proof of concept in this specific repurposing approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
1\. Clinical diagnosis of LPR 2. Age ≥ 18 years 3. RSI \> 13 4. RFS \> 7 5. Documented LPR by MII-pH testing (\> 1 proximal event) 6. Failed 3 month bid PPI therapy 7. Attending laryngology clinic with study providers, and having flexible laryngoscopy and MII-pH testing per routine clinical care with a minimum of three months between clinic visits (standard practice) 8. For continued participation after ATRU V1/V2: 1. Hepatic Function Panel must be within normal limits 2. Results from V1 safety labs must all be within normal limits 3. Patient agrees not to make any changes to their usual diet and/or anti-reflux medications during the study. 4. Patient is compliant with eDiary completion; that is, they have completed the eDiary questions on at least 5 days each week during the 14 calendar days before the start of the Treatment Period. 5. Patient is compliant with continuing any current PPI (if using) during the 14 calendar days before the start of the Treatment Period. Patients are considered compliant if, as reported in the daily eDiary, they continued taking their current PPI (if using) on at least 5 days each week during the 14 calendar days before the start of the Treatment Period. 4.2 EXCLUSION CRITERIA 1. Age ≥ 65 years 2. Patient is not fluent and literate in English. 3. Pregnant (or plan to be) and nursing mothers 4. Women of child-bearing potential not willing to comply with contraceptive requirements during the study treatment and for 1 week following the last dose of study drug. o Definition of women of child-bearing potential Non-post-menopausal female, who has not had a bilateral oophorectomy or medically documented ovarian failure. A subject may be considered to be post-menopausal when there is either: \- twelve (12) months of spontaneous amenorrhea or; \- six (6) months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or; \- six (6) weeks postsurgical bilateral oophorectomy with or without hysterectomy. A female who has had a tubal ligation sterilization or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g., egg donation, participation in in vitro fertilization). * Contraceptive requirements Fosamprenavir may decrease the effectiveness of combined hormonal contraception through significant CYP3A4 induction of estrogen. If subjects' preferred choice of contraception is combined hormonal contraception, subjects must also agree to use a second method of contraception (condom + spermicide) during study drug treatment. Other acceptable highly effective forms of contraception include: * Medroxyprogesterone acetate injectable * Intrauterine Device * Female Sterilization * Male Sterilization 4. Currently being treated with another investigational medical device and/or drug 5. A history of gastric or esophageal surgery 6. Gastrointestinal disease that might interfere symptom questionnaire, e.g. inflammatory bowel syndrome 7. A history of laryngeal or neck surgery including thyroidectomy and laryngomicroscopic surgery 8. Suspected esophageal cancer 9. Nasopharyngeal cancer 10. Previously undergone anti-reflux surgery 11. Polypharmacy (five or more concurrent medications due to comorbidities) 12. Any contraindications to FOS including the following: a. Patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome) to any of the components of this product or to amprenavir. b. Patients taking any drugs that are highly dependent on cytochrome P450 (CYP)3A4 for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Specifically i. Alpha 1-adrenoreceptor antagonist: Alfuzosin ii. Antimycobacterial: Rifampin iii. Antipsychotic: pimozide iv. Ergot derivatives: Dihydroergotamine, ergonovine, ergotamine, methylergonovine v. GI motility agent: Cisapride vi. Herbal product: St. John's wort ( Hypericum perforatum) vii. Lipid modifying agents: Lomitapide, lovastatin, simvastatin viii. Non-nucleoside reverse transcriptase inhibitor: Delavirdine ix. PDE5 inhibitor: Sildenafil (Revatio) x. Sedative/hypnotics: Midazolam, triazolam 13. Patients not willing to avoid eating grapefruit and Seville oranges for five days prior to the first day of dosing study drug through the final study visit. 14\. Patients taking any of the prohibited medications or foods listed in Section 5.6.3 15. Anticipated poor understanding or compliance of the study protocol 16. History of hepatic impairment 17. Sulfa Allergy 18. Hemophilia 19. Active tuberculosis (TB) or history of active TB. 20. History of latent TB (e.g., positive QuantiFERON-TB test) without history of active TB unless the subject has completed a documented course of prophylactic treatment. 21\. History of human immunodeficiency virus (HIV) infection or positive for HIV 22. . Patients positive for hepatitis (Seropositive for hepatitis B surface antigen \[HBsAg\] or Hepatitis C virus \[HCV\] RNA positive) or taking HCV protease inhibitors such as boceprevir, simeprevir and paritaprevir 23. Not willing to refrain from taking biotin containing supplement for at least 12 hours before Visit 1. 24\. Patient has an acute or chronic condition that, in the Investigator's opinion, would limit the patient's ability to complete or participate in this clinical study. 25\. Additionally, subjects without the following will be excluded: 1. Ownership of an electronic with access to internet websites and email required to conduct the DRSD, PGI-S, and PGI-C 2. Internet access 3. A valid email address for notifications
Where it's running
-
Froedtert Hospital
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Ally Vandenberg, BSc
- Email: avandenberg@mcw.edu
- Phone: (414)955-2659
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mechanism-guided treatment versus proton-pump inhibitor therapy for chronic throat symptoms
This trial will test whether a mechanism-guided approach combining personalized acid-suppression and voice therapy helps adults (18–89) with chronic throat symptoms more than usual proton pump inhibitor (PPI) treatment.
-
Immunotherapy with nodal-sparing radiation for head and neck cancer
This study tests whether giving pembrolizumab before and after a focused radiation and surgery plan helps boost the immune response in patients with surgically removable head and neck squamous cell cancer.
-
Stimulating the aging brain with brain and sensory stimulation for language), wait
This study tests whether transcranial alternating current stimulation (tACS) and multisensory stimulation can improve verbal short-term memory in people with Primary Progressive Aphasia.
-
Amnioinfusion during labor to protect neonatal brain in chorioamnionitis
This trial tests whether giving fluid into the uterus during labor for pregnancies affected by chorioamnionitis can help protect the baby’s brain.
-
Protein drinks during labor to help blood sugar stay steadier for pregnant people with insulin-treated diabetes
This study tests whether high-protein beverages during labor help keep a pregnant person’s blood sugar steadier than standard clear liquids when they have diabetes managed with insulin.
-
Ear-based nerve stimulation for children with cyclic vomiting syndrome
This study will try a small ear nerve stimulator to reduce vomiting, nausea, and stomach pain in children who have cyclic vomiting syndrome.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.