TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

NCT02410772 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 6655
• Study Type: interventional
• Target: 2,516
• Locations: 13 countries
• Sites: 33

Brief 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). 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. 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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  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

  eight weeks

• Time to Stable Sputum Culture Conversion

  four or six months

• Discontinuation of Assigned Treatment for a Reason Other Than Microbiological Ineligibility (Tolerability)

  four or six months

• Estimated Steady State Efavirenz PK Parameters Including Mid-dosing Interval Concentration

  four months

• TB Disease-free Survival at Eighteen Months After Study Treatment Assignment

  Eighteen months after study treatment assignment.

Other Outcomes (2)

• Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculosis Deaths Have an Unfavorable Outcome

  12 months

• Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculosis Deaths Have a Favorable Outcome

  12 months

Study Arms (3)

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

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

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

Drug: rifapentine and moxifloxacin

Interventions

rifapentine DRUG

Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment

Also known as: Priftin

Regimen 2

rifapentine and moxifloxacin DRUG

Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol.

Also known as: Priftin and Avelox

Regimen 3

control DRUG

standard six-month treatment

Regimen 1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: collaborator
• Centers for Disease Control and Prevention: lead

Study Sites (33)

TBTC Site 82/ ACTG Site 801 USCF AIDS CRS

San Francisco, California, 94110, United States

Location

TBTC Site 24 Columbia Unversity

New York, New York, 10032, United States

Location

TBTC Site 20 UNTHSC (University of North Texas Health Science Center)

Fort Worth, Texas, 76104, United States

Location

TBTC Site 62 Baylor College of Medicine & Affiliated Hospitals/VA

Houston, Texas, 77030, United States

Location

TBTC Site 63 San Antonio VA Medical Center (South Texas Group)

San Antonio, Texas, 78229-4404, United States

Location

TBTC Site 94/ ACTG Site 12201 Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

TBTC Site 91/ ACTG Site 12101 Insituto Nacional de Pesquisa Clínica Evandro Chagas

Rio de Janeiro, 21040-360, Brazil

Location

TBTC Site 36 TB and Chest Service of Hong Kong, China

Hong Kong, China

Location

TBTC Site 67/ ACTG Site 31730 GHESKIO centers IMIS

Port-au-Prince, Ouest, HT 6124, Haiti

Location

TBTC Site 45/ ACTG Site 30022: Les Centres Gheskio (INLR)

Port-au-Prince, Ouest, HT6110, Haiti

Location

TBTC Site 43/ ACTG Site 31441 BJ Medical College

Pune, Maharashtra, 4110011, India

Location

TBTC Site 44/ ACTG Site 11701 CART CRS, YRGCARE Medical Centre VHS

Chennai, Tamil Nadu, 600113, India

Location

TBTC Site 02/ ACTG 12501 Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS

Kericho, Kericho County, 20200, Kenya

Location

TBTC Site 39/ ACTG Site 31460 Kisumu CRS

Kisumu, Nyanza Province, 40100, Kenya

Location

TBTC Site 03/ ACTG Site 12601 Moi University Clinical Research Site

Eldoret, 30100, Kenya

Location

TBTC Site 04/ ACTG Site 30301 Blantyre CRS (or College of Medicine - Johns Hopkins Research Project, COM-JHP)

Blantyre, Malawi

Location

TBTC Site 05/ ACTG Site 12001 UNC Project Tidziwe Centre

Lilongwe, Malawi

Location

TBTC Site 90/ ACTG Site 11301 Asociacion Civil Impacta Salud y Educacion

Lima, Lima 04, Peru

Location

TBTC Site 93/ ACTG Site 11302 CRS San Miguel

Lima, Lima 32, Peru

Location

TBTC Site 10/ ACTG Site 31718 TASK Applied Science

Bellville, Cape Town, 7530, South Africa

Location

TBTC Site 09/ ACTG Site 31792 University of Cape Town Lung Institute (Pty) Ltd

Mowbray, Cape Town, 7700, South Africa

Location

TBTC Site 34 Wits Health Consortium Perinatal HIV Research Unit (PHRU)

Soweto, Gauteng, 1864, South Africa

Location

TBTC Site 49/ ACTG Site 12301 Soweto ACTG CRS

Soweto, Johannesburg, 2013, South Africa

Location

TBTC Site 06/ ACTG Site 11201 Durban International Clinical Research Site

Durban, KwaZulu-Natal, 4093, South Africa

Location

TBTC Site 01/ACTG Site 8950 FAM CRU

Parow Valley, Western Cape, 7505, South Africa

Location

TBTC Site 08/ ACTG Site 31793 South African Tuberculosis Vaccine Initiative (SATVI)

Cape Town, Western Province, 7705, South Africa

Location

TBTC Site 07/ ACTG Site 11101 Wits Helen Joseph CRS

Johannesburg, 2092, South Africa

Location

TBTC Site 42/ ACTG Site 31802 The Thai Red Cross AIDS Research Centre

Pathumwan, Bangkok, 10330, Thailand

Location

TBTC Site 69/ ACTG Site 31784 Thai-CTIU, CMU HIV Treatment CRS

Muang Chiang Mai, Chiang Mai, 50200, Thailand

Location

TBTC Site 11/ ACTG Site 12401 Joint Clinical Research Centre, Kampala Clinical Research Site

Kampala, Uganda

Location

TBTC Site 30 Uganda-Case Western Reserve Research Collaboration

Kampala, Uganda

Location

TBTC Site 37 Vietnam NTP/UCSF Research Collaboration

Hanoi, 10000, Vietnam

Location

TBTC Site 41/ ACTG Site 30313 Parirenyatwa Clinical Research Site

Harare, 263, Zimbabwe

Location

Related Publications (10)

• 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.

  PMID: 39477924 DERIVED

• Xu 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.

  PMID: 39012226 DERIVED

• Ngo 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.

  PMID: 38462673 DERIVED

• Kurbatova 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.

  PMID: 36790881 DERIVED

• Pettit 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.

  PMID: 36041016 DERIVED

• Podany 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.

  PMID: 34918028 DERIVED

• Dorman 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.

  PMID: 33951360 DERIVED

• Scott 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.

  PMID: 33794353 DERIVED

• Bryant KE, Yuan Y, Engle M, Kurbatova EV, Allen-Blige C, Batra K, Brown NE, Chiu KW, Davis H, Elskamp M, Fagley M, Fedrick P, Hedges KNC, Narunsky K, Nassali J, Phan M, Phan H, Purfield AE, Ricaldi JN, Robergeau-Hunt K, Whitworth WC, Sizemore EE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Central monitoring in a randomized, open-label, controlled phase 3 clinical trial for a treatment-shortening regimen for pulmonary tuberculosis. Contemp Clin Trials. 2021 May;104:106355. doi: 10.1016/j.cct.2021.106355. Epub 2021 Mar 10.

  PMID: 33713841 DERIVED

• Dorman SE, Nahid P, Kurbatova EV, Goldberg SV, Bozeman L, Burman WJ, Chang KC, Chen M, Cotton M, Dooley KE, Engle M, Feng PJ, Fletcher CV, Ha P, Heilig CM, Johnson JL, Lessem E, Metchock B, Miro JM, Nhung NV, Pettit AC, Phillips PPJ, Podany AT, Purfield AE, Robergeau K, Samaneka W, Scott NA, Sizemore E, Vernon A, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group and the Tuberculosis Trials Consortium. High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial. Contemp Clin Trials. 2020 Mar;90:105938. doi: 10.1016/j.cct.2020.105938. Epub 2020 Jan 22.

  PMID: 31981713 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

rifapentine; Moxifloxacin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

A study limitation is that placebos were not used, and therefore neither participants nor site staff were blinded to treatment assignment. Another limitation is that only 8% of participants were HIV-coinfected, limiting the power to compare regimens in this important population

Results Point of Contact

• Title: Dr. Ekaterina Kurbatova, MD, PhD, MPH
• Organization: Centers for Disease Control and Prevention

ies3@cdc.gov

4046392017

Study Officials

• Susan Dorman, MD

  Medical University of South Carolina

  STUDY CHAIR

• Payam Nahid, MD, MPH

  University of California at San Francisco

  STUDY CHAIR

• Susan Swindells, MBBS

  University of Nebraska

  STUDY CHAIR

• Richard Chaisson, MD

  Johns Hopkins University

  STUDY CHAIR

• Ekaterina V Kurbatova, MD, PhD, MPH

  Centers for Disease Control and Prevention

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: April 8, 2015
• Study Start: January 25, 2016
• Primary Completion: July 1, 2020
• Study Completion: May 1, 2021
• Last Updated: December 4, 2024
• Results First Posted: September 28, 2021

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

ZA (8); UG (2); BR (2); KE (3); TH (2); VN (1); ZI (1); US (5); IN (2); PE (2); CN (1); HA (2); MA (2)