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A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)

12 maja 2026 zaktualizowane przez: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB

The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

SPECTRA-TB is a Phase 2C, randomized, open-label trial of stratified medicine principles in TB treatment to identify the optimal duration of the HP1500ZM regimen for participants in the lower-risk stratum and to demonstrate improved TB-related favorable outcomes of this regimen in the higher-risk stratum. The study risk stratification includes a higher-risk group (1 control arm and 1 experimental arm) and a lower-risk group (1 control and 5 experimental arms).

Eligible participants will be stratified as either lower- or higher-risk based on the risk stratification algorithm which is based on the following results obtained during the screening period: Xpert MTB/RIF Ultra CT value, extent of disease on chest X-ray, age, BMI, sex at birth, diabetes status, and HIV status using the SPECTRA-TB risk algorithm prior to randomization. Those classified into the lower-risk group (consisting of the low and moderate risk randomization strata to facilitate balancing of risk within each lower-risk treatment arm) will be randomized to SOC or one of five durations of the experimental regimens while those classified into the higher-risk group will be randomized to receive either SOC or a single fixed duration of the experimental regimen. The lower and higher-risk groups will have the following arms:

  • Lower-risk: 10, 12, 14, 16, 18, and 26 weeks (5 experimental arms [weeks 10-18] and one 26-week SOC arm with 100 participants in each arm).
  • Higher-risk: Two arms with 26 weeks duration (one SOC arm with 100 participants and one experimental arm with 200 participants).

All participants will be followed for 72 weeks from randomization for outcomes of efficacy, safety, and tolerability. Participants will be monitored closely for Possible Poor Treatment Response (PPTR), TB treatment failure or TB recurrence, safety, tolerability, and loss to follow-up.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

900

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Argentyna
  • Australia
  • Botswana
      • Gaborone, Botswana
        • Gaborone CRS (Site #: 12701)
        • Kontakt:
      • Gaborone, Botswana
  • Brazylia
      • Rio Grande, Brazylia
        • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site # 12201)
        • Kontakt:
      • Rio de Janeiro, Brazylia, 21040-360
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site #: 12101)
        • Kontakt:
  • Filipiny
    • Cavite
      • Dasmariñas, Cavite, Filipiny, 4114
        • TB HIV Innovations and Clinical Research Foundation Corp. (Site #: 31981)
        • Kontakt:
  • Haiti
      • Port-au-Prince, Haiti, HT-6110
        • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site #: 31730)
        • Kontakt:
      • Port-au-Prince, Haiti, HT-6110
        • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site #: 30022)
        • Kontakt:
  • Indie
      • Chennai, Indie
        • YRG CARE CRS (Site # 32075)
        • Kontakt:
    • Maharashtra
      • Pune, Maharashtra, Indie, 411001
        • Byramjee Jeejeebhoy Government Medical College (BJGMC) CRS (Site #: 31441)
        • Kontakt:
  • Kenia
    • Rift Valley
      • Eldoret, Rift Valley, Kenia, 30100
        • Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601)
        • Kontakt:
      • Kericho, Rift Valley, Kenia, 20200
        • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501)
        • Kontakt:
  • Malawi
      • Blantyre, Malawi
        • Blantyre CRS (Site #: 30301)
        • Kontakt:
          • Dumisile Huwa
          • Numer telefonu: 265-1811885
          • E-mail: dhuwa@jhp.mw
    • Central Region
      • Lilongwe, Central Region, Malawi
  • Meksyk
      • Mexico City, Meksyk, 14000
        • Nutrición-Mexico CRS (Site #: 32078)
        • Kontakt:
  • Peru
      • Callao, Peru
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site # 31970)
        • Kontakt:
      • Lima, Peru
        • Barranco CRS (Site #: 11301)
        • Kontakt:
      • Lima, Peru
      • Lima, Peru
        • Socios en Salud Sucursal Peru CRS (Site # 31985)
        • Kontakt:
  • Tajlandia
      • Bangkok, Tajlandia
        • Siriraj Hospital, Mahidol University NICHD CRS (Site # 5115)
        • Kontakt:
      • Chiang Mai, Tajlandia, 50200
        • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site #: 31784)
        • Kontakt:
          • Daralak Tavornprasit, R.N., M.Sc.
          • Numer telefonu: 176 66-5-3936148
          • E-mail: daralak.t@cmu.ac.th
      • Chiang Rai, Tajlandia
        • Chiangrai Prachanukroh Hospital NICHD CRS (Site # 5116)
        • Kontakt:
    • Bangkok
      • Pathum Wan, Bangkok, Tajlandia, 10330
        • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802)
        • Kontakt:
  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118)
        • Kontakt:
  • Uganda
      • Kampala, Uganda, 10005
        • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site (Site #: 12401)
        • Kontakt:
          • Sandra Rwambuya, M.P.H.
          • Numer telefonu: 256-772-779283
          • E-mail: dxr23@case.edu
      • Kampala, Uganda
        • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site # 30293)
        • Kontakt:
  • Wietnam
      • Hanoi, Wietnam, 100000
        • National Lung Hospital (Site #: 32483)
        • Kontakt:
  • Zimbabwe
      • Harare, Zimbabwe, 263663
        • Milton Park CRS (Site #: 30313)
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.
  • Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.
  • Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.
  • Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.
  • If living with HIV, has a CD4+ cell count of at least 50 cells/mm3 within 60 days before study entry.
  • If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.

  • Has laboratory test results within 7 days before study entry that meet all of the following:

    • alanine aminotransferase (ALT) no more than 3 times the upper limit of normal
    • total bilirubin no more than 2.5 times the upper limit of normal
    • creatinine no more than 2 times the upper limit of normal
    • potassium between 3.5 and 5.5 mEq/L
    • absolute neutrophil count at least 1000/mm3
    • hemoglobin at least 7.0 g/dL
    • platelet count at least 100,000/mm3
  • If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.

  • If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:

    • condoms
    • intrauterine device (IUD) or intrauterine system (IUS)
    • cervical cap with spermicide
    • diaphragm with spermicide
  • If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.
  • Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.
  • Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.

Exclusion Criteria:

  • TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.
  • Received more than 5 days of treatment for active TB within the 24 weeks before study entry.
  • Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.
  • Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.
  • Has a past history of suspected or confirmed drug-resistant TB of any type.
  • Is currently pregnant or breastfeeding.
  • Cannot take medicines by mouth.
  • Has an HIV/AIDS-related opportunistic infection at study entry.
  • Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.
  • Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.
  • Has alcohol-related liver disease.
  • Has liver cirrhosis.
  • Has a history of aortic aneurysm or aortic dissection.
  • Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.
  • Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.
  • Has a known history of acute intermittent porphyria.
  • Weighs less than 30 kg.
  • Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.
  • Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.
  • Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.
  • Is currently taking part in another interventional clinical trial.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Arm 1A: Higher-risk control group
Participants at higher risk of unfavorable outcome will receive 26 weeks of standard-of-care treatment consisting of isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by isoniazid and rifampin for 18 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Rifampin
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Ethambutol
Administered orally once daily
Eksperymentalny: Arm 1B: Higher-risk experimental group
Participants at higher risk of unfavorable outcome will receive 26 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Rifapentine
Administered orally once daily
Lek: Moxifloxacin
Administered orally once daily
Aktywny komparator: Arm 2A: Lower-risk control group
Participants at lower risk of unfavorable outcome will receive 26 weeks of standard-of-care treatment consisting of isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by isoniazid and rifampin for 18 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Rifampin
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Ethambutol
Administered orally once daily
Eksperymentalny: Arm 2B: Lower-risk experimental group (10 week duration)
Participants at lower risk of unfavorable outcome will receive 10 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Rifapentine
Administered orally once daily
Lek: Moxifloxacin
Administered orally once daily
Eksperymentalny: Arm 2C: Lower-risk experimental group (12 week duration)
Participants at lower risk of unfavorable outcome will receive 12 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Rifapentine
Administered orally once daily
Lek: Moxifloxacin
Administered orally once daily
Eksperymentalny: Arm 2D: Lower-risk experimental group (14 week duration)
Participants at lower risk of unfavorable outcome will receive 14 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Rifapentine
Administered orally once daily
Lek: Moxifloxacin
Administered orally once daily
Eksperymentalny: Arm 2E: Lower-risk experimental group (16 week duration)
Participants at lower risk of unfavorable outcome will receive 16 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Rifapentine
Administered orally once daily
Lek: Moxifloxacin
Administered orally once daily
Eksperymentalny: Arm 2F: Lower-risk experimental group (18 week duration)
Participants at lower risk of unfavorable outcome will receive 18 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
Lek: Isoniazid
Administered orally once daily
Lek: Pyrazinamide
Administered orally once daily
Lek: Rifapentine
Administered orally once daily
Lek: Moxifloxacin
Administered orally once daily

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Lower-risk group: Proportion of participants with sustained cure at 52 weeks after randomization
Ramy czasowe: 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable.
52 weeks after randomization
Lower-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
Ramy czasowe: Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the lower-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Baseline through 28 weeks after randomization

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Higher-risk group: Proportion of participants with sustained cure at 52 week after randomization
Ramy czasowe: 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable.
52 weeks after randomization
Higher-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
Ramy czasowe: Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the higher-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Baseline through 28 weeks after randomization
Proportion of participants with sustained cure at 72 weeks after randomization
Ramy czasowe: 72 weeks after randomization
Sustained cure defined as for the primary efficacy outcome measure, except assessed with respect to 72 weeks.
72 weeks after randomization
Cumulative proportion of stable liquid mycobacterial culture conversion by 26 weeks after randomization
Ramy czasowe: Baseline through 26 weeks after randomization
Stable culture conversion is defined as two negative cultures on two different days without an intervening positive culture (irrespective of positive cultures subsequent to stable culture conversion).
Baseline through 26 weeks after randomization
Mean liquid mycobacterial culture log10 days to positivity slope during the first 10 weeks after randomization
Ramy czasowe: During the first 10 weeks after randomization
Liquid mycobacterial culture days to positivity during the 10 weeks following randomization.
During the first 10 weeks after randomization
Proportion of participants who prematurely discontinue study treatment
Ramy czasowe: Baseline through 26 weeks after randomization
Occurrence of premature study treatment discontinuation for any reason other than when the participant has tuberculosis subsequently determined to be resistant to isoniazid, rifampicin, or fluoroquinolones.
Baseline through 26 weeks after randomization

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Współpracownicy

ViiV Healthcare

Śledczy

  • Krzesło do nauki: Susan Dorman, MD, Medical University of South Carolina
  • Krzesło do nauki: Gustavo Velásquez, MD, MPH, University of California, San Francisco
  • Krzesło do nauki: Patrick Phillips, PhD, San Francisco General Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

5 czerwca 2026

Zakończenie podstawowe (Szacowany)

5 czerwca 2029

Ukończenie studiów (Szacowany)

22 października 2029

Daty rejestracji na studia

Pierwszy przesłany

6 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A5414
  • 38987 (Inny identyfikator: DAIDS-ES ID)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Individual participant data that underlie results in the publication, after deidentification.

Ramy czasowe udostępniania IPD

Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.

Kryteria dostępu do udostępniania IPD

  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.
  • For what types of analyses? To achieve aims in the proposal approved by the ACTG.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Warunki

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