Status and phase
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About
The purpose of this study is to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with CFZ loading dose versus 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis (TB).
Full description
This study will compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with CFZ loading dose versus 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis (TB).
Randomization will be stratified based on HIV status and the presence of advanced disease as determined by chest X-ray.
Participants will be randomized to one of three arms:
All participants must receive pyridoxine (vitamin B6) with each dose of isoniazid (INH) based on current local, national or international dosing guidelines.
Arm 1 participants will be treated for 13 weeks (including a 2-week CFZ loading dose of 300 mg daily). Arm 2 participants will be treated for 26 weeks, and Arm C participants will be treated for 4 weeks.
All participants in Arms 1, 2, and C will be followed from randomization to Week 65. Study visits may include physical examinations; blood, urine, and/or sputum collection; chest X-rays; and electrocardiograms (ECG).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Pulmonary TB (among participants with or without history of prior TB treatment) identified within 5 days prior to entry by:
Pulmonary TB diagnosed without known INH resistance (e.g., by LPA) and without known RIF resistance (e.g., by either LPA or Xpert).
Aged ≥18 years.
Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 30 days prior to entry OR
HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of >1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
For participants living with HIV, CD4+ cell count ≥100 cells/mm^3, obtained within 30 days prior to study entry at any network-approved non-US laboratory that is Immunology Quality Assessment (IQA) certified.
For participants living with HIV must be currently receiving or planning to initiate antiretroviral therapy (ART) at or before study week 8.
A verifiable address or residence readily accessible to facilitate directly observed therapy, and willingness to inform the study team of any change of address during the treatment and follow-up period.
The following laboratory values obtained at or within 5 days prior to entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practice (GCLP) and participates in appropriate external quality assurance programs.
For females of reproductive potential, negative serum or urine pregnancy test within 5 days prior to entry by any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or is using a point of care (POC)/CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practice (GCLP) and participates in appropriate external quality assurance programs.
Female participants of reproductive potential must agree not to participate in the conception process (i.e., active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable nonhormonal method of contraception, as listed below, while on study treatment and for 30 days after stopping study medications.
Female participants who are not of reproductive potential must have documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, or bilateral oophorectomy or bilateral tubal ligation.
Documentation of Karnofsky performance score ≥50 within 30 days prior to entry.
Documentation of either the presence or absence of advanced disease as determined by chest X-ray within 5 days prior to entry.
Ability and willingness of participant to provide informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
104 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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