TuberculosisPhase 3S31/A5349NCT02410772
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
A Phase 3 study testing rifapentine and rifapentine and moxifloxacin in people with Tuberculosis, run by Centers for Disease Control and Prevention at 33 sites in 13 countries.
Trial summary
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- rifapentine and rifapentine and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,516 participants
- Where
- 33 sitesin 13 countries
- Study dates
- 25 Jan 2016to May 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with semiquantitative result of 'medium' or 'high' and rifamycin resistance not detected.
- Age twelve (12) years or older
- A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
- Women of child-bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment.
- Documentation of HIV infection status.
- For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to screening.
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- Laboratory parameters done at or within 14 days prior to screening:
- Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal
- Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal
- Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal
- Serum or plasma potassium level greater than or equal to 3.5 meq/L
- Hemoglobin level of 7.0 g/dL or greater
- Platelet count of 100,000/mm3 or greater
- For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening
- Karnofsky score greater than or equal to 60
- Written informed consent
Who cannot join
- Pregnant or breast-feeding.
- Unable to take oral medications.
- Previously enrolled in this study.
- Received any investigational drug in the past 3 months.
- More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs.
- More than five (5) days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs: isoniazid, rifampin, rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline.
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- Known history of prolonged QT syndrome.
- Suspected or documented tuberculosis involving the central nervous system and/or bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis.
- Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine. Individuals who are currently taking efavirenz-based antiretroviral treatment or for whom initiation of efavirenz-based antiretroviral treatment is planned within 17 weeks following enrollment may participate.
- Weight less than 40.0 kg.
- Known allergy or intolerance to any of the study medications.
- Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.
- Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.
- Current or planned incarceration or other involuntary detention.
Trial locations and contacts
33 sites in 13 countries.
33 sites in 13 countries
South Africa8 sites
TBTC Site 10/ ACTG Site 31718 TASK Applied Science
Bellville, Cape Town, 7530
TBTC Site 08/ ACTG Site 31793 South African Tuberculosis Vaccine Initiative (SATVI)
Cape Town, Western Province, 7705
TBTC Site 06/ ACTG Site 11201 Durban International Clinical Research Site
Durban, KwaZulu-Natal, 4093
TBTC Site 07/ ACTG Site 11101 Wits Helen Joseph CRS
Johannesburg, 2092
TBTC Site 09/ ACTG Site 31792 University of Cape Town Lung Institute (Pty) Ltd
Mowbray, Cape Town, 7700
TBTC Site 01/ACTG Site 8950 FAM CRU
Parow Valley, Western Cape, 7505
TBTC Site 34 Wits Health Consortium Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng, 1864
TBTC Site 49/ ACTG Site 12301 Soweto ACTG CRS
Soweto, Johannesburg, 2013
United States5 sites
TBTC Site 20 UNTHSC (University of North Texas Health Science Center)
Fort Worth, Texas, 76104
TBTC Site 62 Baylor College of Medicine & Affiliated Hospitals/VA
Houston, Texas, 77030
TBTC Site 24 Columbia Unversity
New York, New York, 10032
TBTC Site 63 San Antonio VA Medical Center (South Texas Group)
San Antonio, Texas, 78229-4404
TBTC Site 82/ ACTG Site 801 USCF AIDS CRS
San Francisco, California, 94110
Kenya3 sites
TBTC Site 03/ ACTG Site 12601 Moi University Clinical Research Site
Eldoret, 30100
TBTC Site 02/ ACTG 12501 Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
Kericho, Kericho County, 20200
TBTC Site 39/ ACTG Site 31460 Kisumu CRS
Kisumu, Nyanza Province, 40100
Brazil2 sites
TBTC Site 94/ ACTG Site 12201 Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
TBTC Site 91/ ACTG Site 12101 Insituto Nacional de Pesquisa Clínica Evandro Chagas
Rio de Janeiro, 21040-360
Haiti2 sites
TBTC Site 67/ ACTG Site 31730 GHESKIO centers IMIS
Port-au-Prince, Ouest, HT 6124
TBTC Site 45/ ACTG Site 30022: Les Centres Gheskio (INLR)
Port-au-Prince, Ouest, HT6110
India2 sites
TBTC Site 44/ ACTG Site 11701 CART CRS, YRGCARE Medical Centre VHS
Chennai, Tamil Nadu, 600113
TBTC Site 43/ ACTG Site 31441 BJ Medical College
Pune, Maharashtra, 4110011
Malawi2 sites
TBTC Site 04/ ACTG Site 30301 Blantyre CRS (or College of Medicine - Johns Hopkins Research Project, COM-JHP)
Blantyre
TBTC Site 05/ ACTG Site 12001 UNC Project Tidziwe Centre
Lilongwe
Peru2 sites
TBTC Site 90/ ACTG Site 11301 Asociacion Civil Impacta Salud y Educacion
Lima, Lima 04
TBTC Site 93/ ACTG Site 11302 CRS San Miguel
Lima, Lima 32
Thailand2 sites
TBTC Site 69/ ACTG Site 31784 Thai-CTIU, CMU HIV Treatment CRS
Muang Chiang Mai, Chiang Mai, 50200
TBTC Site 42/ ACTG Site 31802 The Thai Red Cross AIDS Research Centre
Pathumwan, Bangkok, 10330
Uganda2 sites
TBTC Site 11/ ACTG Site 12401 Joint Clinical Research Centre, Kampala Clinical Research Site
Kampala
TBTC Site 30 Uganda-Case Western Reserve Research Collaboration
Kampala
Vietnam1 site
TBTC Site 37 Vietnam NTP/UCSF Research Collaboration
Hanoi, 10000
Zimbabwe1 site
TBTC Site 41/ ACTG Site 30313 Parirenyatwa Clinical Research Site
Harare, 263
About this study
Official title: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week.
The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin.
Read more
The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine.
The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.
Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.
Read the detailed description
Title:
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized, open-label, controlled, phase 3 clinical trial
Hypotheses:
- Seventeen (17) week rifapentine-based regimen In previously untreated individuals with active drug-susceptible pulmonary tuberculosis treated with eight weeks of rifapentine (P), isoniazid (H), pyrazinamide (Z) and ethambutol (E) followed by nine weeks of rifapentine plus isoniazid, all given daily throughout, the proportion of participants who experience absence of cure (unfavorable outcome) will not be inferior to that observed in participants who are treated with a standard regimen (eight weeks of rifampin (R), isoniazid, pyrazinamide and ethambutol followed by eighteen weeks of rifampin plus isoniazid), all given daily throughout.
- Seventeen (17) week rifapentine- plus moxifloxacin-containing regimen In previously untreated individuals with active drug-susceptible pulmonary tuberculosis treated with eight weeks of rifapentine, isoniazid, pyrazinamide and moxifloxacin (M), followed by nine weeks of rifapentine, isoniazid, and moxifloxacin, all given daily throughout, the proportion of participants who experience absence of cure (unfavorable outcome) will not be inferior to that observed in participants who are treated with a standard regimen (eight weeks of rifampin, isoniazid, pyrazinamide and ethambutol followed by eighteen weeks of rifampin plus isoniazid), all given daily throughout.
Phase: 3
Design: This will be an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 non-inferiority trial.
Population: Patients with newly diagnosed, previously untreated pulmonary tuberculosis.
Number of Sites: Multiple international sites, primarily sites of the Tuberculosis Trials Consortium and the AIDS Clinical Trials Group.
Study Duration: Duration per participant is approximately 18 months.
Description of Agent or Intervention: After written informed consent, participants will be randomly assigned to receive one of the following oral regimens:
Regimen 1 (control regimen): 2RHZE/4RH
- Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by
- Eighteen weeks of daily treatment with rifampin and isoniazid
Regimen 2 (investigational regimen): 2PHZE/2PH
- Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by
- Nine weeks of daily treatment with rifapentine and isoniazid
Regimen 3 (investigational regimen): 2PHZM/2PHM
- Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by
- Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
Objectives:
Primary:
- To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
Secondary:
- To evaluate the safety of the investigational regimens
- To evaluate the tolerability of the investigational regimens
- To collect and store biospecimens from consenting participants for the purpose of future research on discovery and validation of TB biomarkers
- To determine the correlation of mycobacterial and clinical markers with time to culture conversion, culture status at completion of eight weeks of treatment, treatment failure, and relapse.
- To conduct a pharmacokinetic/pharmacodynamic (PK/PD) study of the test drugs. The main objectives of the PK/PD study are to characterize study drug PK parameters and to determine relationships between treatment outcomes and PK parameters.
- To evaluate the pharmacokinetics of efavirenz-based antiretroviral treatment among patients with TB/HIV co-infection taking efavirenz-based combination antiretroviral therapy and TB treatment with rifapentine
Endpoints:
Primary Endpoints:
- Efficacy: TB disease-free survival at twelve months after study treatment assignment.
- Safety: Proportion of participants with grade 3 or higher adverse events during study drug treatment
Secondary Endpoints:
- TB disease-free survival at eighteen months after study treatment assignment
- Time to stable sputum culture conversion (solid and liquid media considered separately)
- Speed of decline of sputum viable bacilli by automated liquid MGIT culture days to detection
- Proportion of participants who are culture negative at completion of eight weeks of treatment (solid and liquid media considered separately)
- Sensitivity analyses assuming all participants classified as 'not assessable' have a favorable outcome
- Discontinuation of assigned treatment for a reason other than microbiological ineligibility
- Estimated steady state efavirenz PK parameters including mid-dosing interval concentration
- Conditions
- Tuberculosis
- Being tested
- rifapentine, rifapentine and moxifloxacin, control
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifapentineDrug
Also called Priftin
Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment
rifapentine and moxifloxacinDrug
Also called Priftin and Avelox
Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol.
controlDrug
standard six-month treatment
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Active comparator | Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid
All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose.
study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg Receives: Drug: control |
| Regimen 2 | Experimental | Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid
All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose.
study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg Receives: Drug: rifapentine |
| Regimen 3 | Experimental | Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin
All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose.
study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; moxifloxacin, 400 mg Receives: Drug: rifapentine and moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population)
To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of "favorable", "unfavorable", or "not assessable" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718.
Measured: Twelve months after treatment assignment
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population)
- To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of "favorable", "unfavorable", or "not assessable" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718.
Measured: Twelve months after treatment assignment
Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population)
- To evaluate the Safety of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the Safety of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis Grade 3 or higher Adverse Events are collected by Clinical sites in systematic way through the laboratory tests and physical exam during regular study follow up visits and also in a non-systematic way when it was self-reported by participants during the study visits. The events are graded by site investigators per Common Terminology Criteria for Adverse Events (CTCAE V4.03
Measured: Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1)
Secondary outcomes (7)
Proportion of Participants Who Are Culture Negative at Eight Weeks
Proportion of participants who are culture negative at eight weeks, liquid media
Measured: eight weeks
Time to Stable Sputum Culture Conversion
Time to stable sputum culture conversion, liquid media
Measured: four or six months
Discontinuation of Assigned Treatment for a Reason Other Than Microbiological Ineligibility (Tolerability)
Tolerability of the regimen is evaluated using the outcome of discontinuation of assigned treatment for a reason other than microbiological ineligibility.
Measured: four or six months
Estimated Steady State Efavirenz PK Parameters Including Mid-dosing Interval Concentration
Among participants with HIV infection receiving efavirenz-based antiretroviral therapy, number of participants who maintained plasma efavirenz concentrations ≥1 mg/L during TB treatment.
Measured: four months
TB Disease-free Survival at Eighteen Months After Study Treatment Assignment
- To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
Measured: Eighteen months after study treatment assignment.
TB Disease-free Survival at Eighteen Months After Study Treatment Assignment
- To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
Measured: Eighteen months after treatment assignment
Speed of Decline of Sputum Viable Bacilli by Automated Liquid MGIT Culture Days to Detection
Parameter estimates of the nonlinear mixed effect models describing longitudinal time to positive (TTP)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start25 Jan 2016
- Primary completionJul 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Responsible party
- Sponsor
- Investigators
- Susan Dorman, MD, Study chair, Medical University of South CarolinaPayam Nahid, MD, MPH, Study chair, University of California at San FranciscoSusan Swindells, MBBS, Study chair, University of NebraskaRichard Chaisson, MD, Study chair, Johns Hopkins UniversityEkaterina V Kurbatova, MD, PhD, MPH, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410772
- Sponsor's protocol ID
- 6655
- Acronym
- S31/A5349
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2015
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data being collected in CDISC format.
Publications
Chang VK, Imperial MZ, Phillips PPJ, Velasquez GE, Nahid P, Vernon A, Kurbatova EV, Swindells S, Chaisson RE, Dorman SE, Johnson JL, Weiner M, Jindani A, Harrison T, Sizemore EE, Whitworth W, Carr W, Bryant KE, Burton D, Dooley KE, Engle M, Nsubuga P, Diacon AH, Nhung NV, Dawson R, Savic RM; AIDS Clinical Trial Group; Tuberculosis Trials Consortium. Risk-stratified treatment for drug-susceptible pulmonary tuberculosis. Nat Commun. 2024 Oct 30;15(1):9400. doi: 10.1038/s41467-024-53273-7.
PubMed 39477924Xu AY, Velasquez GE, Zhang N, Chang VK, Phillips PPJ, Nahid P, Dorman SE, Kurbatova EV, Whitworth WC, Sizemore E, Bryant K, Carr W, Brown NE, Engle ML, Nhung NV, Nsubuga P, Diacon A, Dooley KE, Chaisson RE, Swindells S, Savic RM. Pyrazinamide Safety, Efficacy, and Dosing for Treating Drug-Susceptible Pulmonary Tuberculosis: A Phase 3, Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2024 Dec 1;210(11):1358-1369. doi: 10.1164/rccm.202401-0165OC.
PubMed 39012226Ngo HX, Xu AY, Velasquez GE, Zhang N, Chang VK, Kurbatova EV, Whitworth WC, Sizemore E, Bryant K, Carr W, Weiner M, Dooley KE, Engle M, Dorman SE, Nahid P, Swindells S, Chaisson RE, Nsubuga P, Lourens M, Dawson R, Savic RM. Pharmacokinetic-Pharmacodynamic Evidence From a Phase 3 Trial to Support Flat-Dosing of Rifampicin for Tuberculosis. Clin Infect Dis. 2024 Jun 14;78(6):1680-1689. doi: 10.1093/cid/ciae119.
PubMed 38462673Kurbatova EV, Phillips PPJ, Dorman SE, Sizemore EE, Bryant KE, Purfield AE, Ricaldi J, Brown NE, Johnson JL, Wallis CL, Akol JP, Ocheretina O, Van Hung N, Mayanja-Kizza H, Lourens M, Dawson R, Nhung NV, Pierre S, Musodza Y, Shenje J, Badal-Faesen S, Vilbrun SC, Waja Z, Peddareddy L, Scott NA, Yuan Y, Goldberg SV, Swindells S, Chaisson RE, Nahid P. A Standardized Approach for Collection of Objective Data to Support Outcome Determination for Late-Phase Tuberculosis Clinical Trials. Am J Respir Crit Care Med. 2023 May 15;207(10):1376-1382. doi: 10.1164/rccm.202206-1118OC.
PubMed 36790881Pettit AC, Phillips PPJ, Kurbatova E, Vernon A, Nahid P, Dawson R, Dooley KE, Sanne I, Waja Z, Mohapi L, Podany AT, Samaneka W, Savic RM, Johnson JL, Muzanyi G, Lalloo UG, Bryant K, Sizemore E, Scott N, Dorman SE, Chaisson RE, Swindells S; Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) A5349 study team. Rifapentine With and Without Moxifloxacin for Pulmonary Tuberculosis in People With Human Immunodeficiency Virus (S31/A5349). Clin Infect Dis. 2023 Feb 8;76(3):e580-e589. doi: 10.1093/cid/ciac707.
PubMed 36041016Podany AT, Pham M, Sizemore E, Martinson N, Samaneka W, Mohapi L, Badal-Faesen S, Dawson R, Johnson JL, Mayanja H, Lalloo U, Whitworth WC, Pettit A, Campbell K, Phillips PPJ, Bryant K, Scott N, Vernon A, Kurbatova EV, Chaisson RE, Dorman SE, Nahid P, Swindells S, Dooley KE, Fletcher CV. Efavirenz Pharmacokinetics and Human Immunodeficiency Virus Type 1 (HIV-1) Viral Suppression Among Patients Receiving Tuberculosis Treatment Containing Daily High-Dose Rifapentine. Clin Infect Dis. 2022 Sep 10;75(4):560-566. doi: 10.1093/cid/ciab1037.
PubMed 34918028Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.
PubMed 33951360Scott NA, Lee KK, Sadowski C, Kurbatova EV, Goldberg SV, Nsubuga P, Kitshoff R, Whitelaw C, Thuy HN, Batra K, Allen-Blige C, Davis H, Kim J, Phan M, Fedrick P, Chiu KW, Heilig CM, Sizemore E; AIDS Clinical Trials Group and The Tuberculosis Trials Consortium. Optimizing drug inventory management with a web-based information system: The TBTC Study 31/ACTG A5349 experience. Contemp Clin Trials. 2021 Jun;105:106377. doi: 10.1016/j.cct.2021.106377. Epub 2021 Mar 29.
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