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NotableRecruitment openedStart date: May 15, 2026 to Jul 15, 2026 · Primary completion pushed from Jun 1, 2027 to Jul 1, 2027 · Completion pushed from Oct 1, 2027 to Oct 1, 2028 · 2 morev19Show 5 more changesShow less
Start date: May 15, 2026 to Jul 15, 2026
Primary completion pushed from Jun 1, 2027 to Jul 1, 2027
NotableStart date: Apr 1, 2026 to May 15, 2026Site contact updatedv18Show 1 more changeShow less
Site contact updated
NotableStart date: Mar 1, 2026 to Apr 1, 2026Eligibility criteria expanded, about 334 words · Study description expanded, about 331 words · Site contact updatedv17Show 3 more changesShow less
NotablePrimary completion date: Feb 1, 2026 to Jun 1, 2027Start date: Nov 1, 2024 to Sep 1, 2025 · Completion date: Apr 1, 2026 to Oct 1, 2027 · Site contact updatedv13Show 3 more changesShow less
Start date: Nov 1, 2024 to Sep 1, 2025
Completion date: Apr 1, 2026 to Oct 1, 2027
Site contact updated
NotablePhase: Phase 3 to Phase 2Start date: Jun 15, 2024 to Nov 1, 2024 · Primary endpoints revised (2) · Primary completion date: Oct 15, 2025 to Feb 1, 2026 · 6 morev12Show 9 more changesShow less
Start date: Jun 15, 2024 to Nov 1, 2024
Primary endpoints revised (2)
Primary completion date: Oct 15, 2025 to Feb 1, 2026
Completion date: Oct 15, 2025 to Apr 1, 2026
Interventions: Lexiva (Drug) to Fosamprenavir Calcium (Drug), Placebo (Other)
NotablePrimary and study completion dates: Oct 15, 2024 to Oct 15, 2025Start date: Oct 15, 2023 to Jun 15, 2024v11Show 1 more changeShow less
Start date: Oct 15, 2023 to Jun 15, 2024
NotableStart date: Jun 30, 2023 to Oct 15, 2023Primary completion date: Jun 1, 2024 to Oct 15, 2024 · Completion date: Aug 1, 2024 to Oct 15, 2024v10Show 2 more changesShow less
Primary completion date: Jun 1, 2024 to Oct 15, 2024
Completion date: Aug 1, 2024 to Oct 15, 2024
NotableStart date: Jan 31, 2023 to Jun 30, 2023Primary completion date: Jan 2, 2024 to Jun 1, 2024 · Completion date: Mar 1, 2024 to Aug 1, 2024v9Show 2 more changesShow less
Primary completion date: Jan 2, 2024 to Jun 1, 2024
Completion date: Mar 1, 2024 to Aug 1, 2024
NotableStart date: Dec 1, 2022 to Jan 31, 2023v8
NotableStart date: Jul 1, 2022 to Dec 1, 2022v7
NotableStart date: Feb 15, 2022 to Jul 1, 2022v6
NotableStart date: Jan 3, 2022 to Feb 15, 2022Study site revisedv5Show 1 more changeShow less
NotableStart date: Jul 1, 2021 to Jan 3, 2022Primary completion date: Jun 30, 2024 to Jan 2, 2024 · Completion date: Jun 30, 2024 to Mar 1, 2024v4Show 2 more changesShow less
Primary completion date: Jun 30, 2024 to Jan 2, 2024
Completion date: Jun 30, 2024 to Mar 1, 2024
NotablePrimary and study completion dates: Nov 30, 2025 to Jun 30, 2024Start date: Dec 1, 2020 to Jul 1, 2021v3Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Laryngopharyngeal Reflux (LPR) is a common condition that causes symptoms like chronic cough, throat clearing, hoarseness, and trouble swallowing. If not treated, LPR can lead to long-term throat damage and may increase the risk of throat cancer. More than 20% of the people in the United States are estimated to have LPR, yet there is no effective medication approved to treat it. Drugs called proton pump inhibitors (PPIs) are often used to treat LPR, even though they were designed for stomach acid problems. These medications reduce acid but do not stop reflux from happening, so they often do not help LPR patients. Despite poor results, PPIs are widely prescribed, are very costly, and can cause side effects.
Research shows that a digestive enzyme called pepsin plays a key role in LPR. Pepsin can damage the throat and voice box even when acid is not present. Laboratory studies found that certain HIV medications can block damage caused by pepsin. People taking these medications for HIV appear to have a much lower rate of LPR. This study will test fosamprenavir, an FDA-approved HIV drug, as a treatment for LPR. We will conduct a 14-week, double-blind, placebo-controlled clinical trial in patients with LPR who did not improve with standard treatment. Participants will receive either fosamprenavir or placebo, randomly, and symptoms will be measured before and after treatment using standard questionnaires and daily symptom tracking.
Because there is no effective medical treatment for LPR. this study aims to test a safe, existing drug that targets the underlying cause of the disease.