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

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Conditions studied: Opportunistic Infections, HIV Related, Disseminated Mycobacterium Avium Complex Infection

In brief

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.

Key facts

Study ID: NCT07585461
Run by: Shanghai Public Health Clinical Center
People needed: 124
Starts: 2026-04-30
Expected to finish: 2028-12-31
Last updated by the study team: 2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Full record on ClinicalTrials.gov

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