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New drug cocktail aims to beat tough infection in HIV patients

NCT ID NCT07585461

Disease control Sponsor: Shanghai Public Health Clinical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether adding a fluoroquinolone antibiotic to the standard three-drug treatment helps HIV patients with a serious bacterial infection called disseminated MAC. About 124 adults will be randomly assigned to get either the standard therapy or the four-drug combo for the first 8 weeks. The main goal is to see if more patients feel better by day 28, with fewer fevers and improved symptoms.

What this could mean

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

Active substance
fluoroquinolone (levofloxacin or moxifloxacin) added to standard triple therapy
What this could lead to
If it works, this could lead to a more effective treatment for HIV patients with severe MAC infections, improving early recovery and reducing bacterial load.
What could go wrong
This is an early-stage trial with only 124 participants, so results may not apply to everyone. Adding a fluoroquinolone also raises risks like heart rhythm problems and side effects.

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 124 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: * Age ≥18 years * HIV infection confirmed * Disseminated Mycobacterium avium complex (MAC) infection confirmed by positive culture from a sterile site or positive molecular/sequencing-based detection from a sterile site specimen considered clinically significant * Systemic manifestations consistent with disseminated infection * Planned initiation of standard antimycobacterial therapy * Able and willing to provide written informed consent Exclusion Criteria: * Prior effective antimycobacterial treatment for \>14 days before enrollment * Known macrolide resistance, if susceptibility data are available * Hypersensitivity to macrolides, ethambutol, rifamycins, or fluoroquinolones * Baseline QTc \>500 ms or history of significant cardiac arrhythmia * Uncorrected hypokalemia or hypomagnesemia * History of severe adverse reaction to fluoroquinolones, such as tendon rupture or severe neuropathy * Severe hepatic impairment or severe renal dysfunction precluding study treatment * Concomitant medications that significantly prolong QT interval and cannot be safely discontinued * Pregnancy or breastfeeding * Coexisting infection requiring non-protocol antimycobacterial therapy, such as active tuberculosis * Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results

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Conditions

The condition(s) this trial relates to.

AIDS-related disorder AIDS-Related Opportunistic Infections HIV infectious disease Mycobacterium avium complex disease

As listed by the trial registrant

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

Disseminated mycobacterium avium complex infection Opportunistic infections, HIV-related

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.