Not Yet RecruitingNot Applicable

Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial

124 participantsStarted 2026-04-30

Plain-language summary

Background: Disseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Despite the widespread use of antiretroviral therapy (ART), disseminated MAC (DMAC) continues to be associated with significant morbidity and mortality. The current standard treatment consists of a macrolide-based triple regimen, including a macrolide, ethambutol, and rifamycin. However, in patients with high mycobacterial burden or profound immunodeficiency, early microbiological response and clinical improvement are often suboptimal, and treatment is complicated by drug interactions and tolerability issues. Objective: This study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected patients with disseminated MAC infection. Methods: This is a prospective, multicenter, randomized, open-label, controlled trial. A total of 124 adult HIV-infected patients with confirmed disseminated MAC infection will be randomly assigned in a 1:1 ratio to receive either standard triple therapy (macrolide, ethambutol, and rifamycin) or an intensified four-drug regimen with the addition of a fluoroquinolone during the initial 8-week intensive phase. Participants will be followed for at least 24 weeks. Outcomes: The primary endpoint is the clinical symptom resolution rate at Day 28. Secondary endpoints include microbiological outcomes (culture or molecular conversion at Days 28, 56, and 84), time to culture conversion, mortality, relapse, and safety outcomes including adverse events and QT interval prolongation. Significance: This study will provide prospective evidence on whether an intensified treatment strategy can improve early clinical response and microbiological clearance in disseminated MAC infection, while maintaining an acceptable safety profile. The findings may help optimize treatment strategies for HIV-associated disseminated MAC infection.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Symptom Resolution Rate at Day 28

Timeframe: Day 28 (±3 days)

Trial details

NCT IDNCT07585461

SponsorShanghai Public Health Clinical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Li LIU, M.D.

8618916091026 liuli@shaphc.org

View on ClinicalTrials.gov More Opportunistic Infections, HIV Related trials