NCT07585461Toborzás még nem indult
Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled Trial
A Multicenter, Randomized, Controlled Trial Evaluating the Efficacy and Safety of Adding Fluoroquinolone (Levofloxacin or Moxifloxacin) to Standard Triple Therapy in Disseminated Mycobacterium Avium Complex Infection
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 124 (tervezett)
- Első benyújtás
- 2026. ápr. 14.
- Kezdés
- 2026. ápr. 30.
- Elsődleges befejezés
- 2028. dec. 31.
- Fő szponzor
- Shanghai Public Health Clinical Center
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT07585461
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 124
- 2026. ápr. 30. és az elsődleges befejezés (2028. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior effective antimycobacterial treatment for \>14 days before enrollment
Más betegség
- Hypersensitivity to macrolides, ethambutol, rifamycins, or fluoroquinolones
- History of severe adverse reaction to fluoroquinolones, such as tendon rupture or severe neuropathy
- Severe hepatic impairment or severe renal dysfunction precluding study treatment
- 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
Laborértékek
- Baseline QTc \>500 ms or history of significant cardiac arrhythmia
- Concomitant medications that significantly prolong QT interval and cannot be safely discontinued
Egyéb
- Known macrolide resistance, if susceptibility data are available
- Uncorrected hypokalemia or hypomagnesemia
- Pregnancy or breastfeeding
Kiket keres a vizsgálat
- 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
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