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Could an HIV drug tame tough reflux? new trial aims to find out

NCT ID NCT06704100

Symptom relief Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This phase 2 trial tests whether a combination of fosamprenavir (an HIV medication) and sodium alginate (a seaweed-based thickener) can ease heartburn and regurgitation in people whose reflux doesn't improve with standard acid-blocking pills. Sixty adults aged 18 to 65 will take either the study drug or a placebo twice daily for 8 weeks and track their symptoms. The goal is to see if this new approach offers relief where current treatments fall short.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fosamprenavir-Sodium Alginate (a combination of an antiviral drug and a seaweed-derived thickener)
What this could lead to
If it works, this could offer a new treatment option for people with persistent heartburn and reflux that standard acid-blocking pills don't relieve.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. The drug may prove no better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2027

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged 50-65 selected as candidate for anti-reflux surgery by study providers. 2. Patient has received, and continued having GERD symptoms during, standard-labeled dose, daily, PPI therapy for a minimum of 8 weeks before the Screening Visit. 3. Patient has a diagnosis of GERD with endoscopy and/or pH-metry test within the past two years demonstrating 1 or more of the following: 1. Erosive esophagitis (Grade A or greater based on the Los Angeles classification of esophagitis; Appendix 3) 2. Evidence of pathological acid reflux (pH \< 4 for ≥ 4-6% off therapy or ≥ 1-4% on therapy) during a 24-hour time interval of pH testing 4. Patient reports heartburn severity (HS, Item #1 on mRESQ-eD) ≥ 3 (moderate) on at least 2 days and has an average HS of ≥ 2 (mild) during the last 7 days of the Pretreatment Period before Randomization. Exclusion Criteria: 1. Patient is suspected of having, functional upper gastrointestinal disorders such as functional dyspepsia or functional heartburn diagnosed by the Rome IV criteria; Appendix 4. 2. Patient has endoscopically confirmed eosinophilic esophagitis (EE).

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroesophageal reflux disease Refractory gastroesophageal reflux disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

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