Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis, MDR-TB, RR-TB
In brief
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug-resistant tuberculosis (MDR-TB). The primary objectives are to assess the safety and tolerability of AHA combined with short-course regimens, and to determine the recommended phase II dose (RP2D) of AHA. The secondary objectives include evaluating the 8-week sputum culture conversion rate, pharmacokinetic parameters, and exploring DNA damage repair biomarkers as potential indicators of treatment response.
Key facts
- Study ID
- NCT07393438
- Run by
- Shanghai Pulmonary Hospital, Shanghai, China
- People needed
- 120
- Starts
- 2026-02-21
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 14 to < 65 years, male or female
- Confirmed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) by molecular testing (e.g., Xpert MTB/RIF) or drug susceptibility testing
- Positive sputum culture for Mycobacterium tuberculosis or positive molecular test
- Chest imaging consistent with active pulmonary TB, or histologically confirmed extrapulmonary TB (excluding CNS, osteoarticular, and disseminated TB)
- Body weight ≥ 40 kg
- Karnofsky Performance Status ≥ 50
- Adequate laboratory parameters:
- Hemoglobin ≥ 8.0 g/dL
- ANC ≥ 1000/mm³
- Platelets ≥ 75,000/mm³
- ALT/AST ≤ 3 × ULN
- Total bilirubin ≤ 2 × ULN
- Creatinine clearance ≥ 30 mL/min
- QTcF interval < 450 ms (male) or < 470 ms (female)
- HIV-negative, confirmed by approved testing
- No prior exposure to bedaquiline, delamanid, or linezolid for more than 1 month
- Female participants of childbearing potential must agree to use effective contraception and have a negative pregnancy test
- Signed informed consent
You may not qualify if…
- Central nervous system TB (e.g., TB meningitis), osteoarticular TB, or disseminated/miliary TB
- Known allergy or serious adverse reaction to any study drug or background regimen component
- Known resistance to bedaquiline, delamanid, or linezolid
- Use of anti-TB drugs within the past 30 days that may interfere with study assessments, except in documented treatment failure cases
- Severe comorbidities, including:
- NYHA Class III-IV heart failure
- History or risk factors for Torsades de Pointes
- Child-Pugh B or C cirrhosis
- Uncontrolled diabetes (HbA1c > 10%)
- Active malignancy
- Current use of QT-prolonging medications that cannot be substituted
- Current use of MAO inhibitors or serotonergic drugs
- BMI < 17 kg/m² with severe malnutrition
- Grade 3-4 peripheral neuropathy at baseline
- Pregnant or breastfeeding women
- Any condition that, in the investigator's judgment, may interfere with study completion or data interpretation
Where it is running
- Anhui Chest Hospital — Hefei, Anhui, China
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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