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Old drug, new trick: can spironolactone silence HIV?

NCT ID NCT07415811

Knowledge-focused Sponsor: University of Sao Paulo General Hospital 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This small, early study is testing whether spironolactone, a drug already approved for high blood pressure, can reduce the hidden HIV reservoir in people on effective HIV treatment. Researchers will give the drug to 12 adults (both with and without HIV) to see how it affects a key protein and how the body processes it. The goal is to gather initial safety and biological data to see if spironolactone could one day be part of an HIV cure strategy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

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

Started

Jul 2024

Expected to finish

Jul 2027

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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adults aged 18 to 60 years. * Able and willing to provide written informed consent. * For HIV-negative cohort: documented HIV-negative test result at screening. * For HIV-positive cohort: * documented HIV-1 infection; * on stable antiretroviral therapy (ART); .plasma HIV-1 RNA below the limit of detection at screening. Exclusion Criteria: * Pregnancy or breastfeeding. * Known hypersensitivity or contraindication to spironolactone. * Clinically significant baseline electrolyte abnormalities, including hyperkalemia, or conditions that increase the risk of hyperkalemia. * Clinically significant renal dysfunction or hepatic dysfunction that, in the investigator's judgment, increases risk with spironolactone. * History of clinically significant cardiac arrhythmias or screening electrocardiogram findings that contraindicate spironolactone in the investigator's judgment. * Use of aspirin (acetylsalicylic acid) on a continuous basis or recent use prior to screening, or planned use during the study. * Current use of medications or supplements that increase potassium levels or otherwise substantially increase the risk of hyperkalemia, or inability/unwillingness to avoid high-potassium supplements and products during the intervention period. * Use of non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids that cannot be discontinued for the duration of study drug administration. * Any condition that, in the investigator's judgment, would interfere with study participation, study procedures, or participant safety.

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Conditions

The condition(s) this trial relates to.

Bites and Stings HIV infectious disease

As listed by the trial registrant

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

HIV

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Grupo de Pesquisa Clínica em Moléstias Infecciosas

    São Paulo, São Paulo, 05401000, Brazil

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