Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis

NCT00864383 | Completed Phase 3 Results DMC

• 2 other identifiers: REMoxTBISRCTN85595810
• Study Type: interventional
• Target: 1,931
• Locations: 8 countries
• Sites: 42

Brief Summary

REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy. The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.

Conditions

Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (2)

• Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).

  The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.

  18 months (within one year of completion of therapy)

• Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)

  The number of participants includes all patients who had at least one grade 3 or 4 adverse event.

  18 months (within one year of completion of therapy)

Secondary Outcomes (7)

• Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).

  18 months (within one year of completion of therapy)

• Number of Patients Who Are Culture Negative (Solid LJ Culture)

  8 weeks

• Number of Patients Who Are Culture Negative (Liquid MGIT Culture)

  8 weeks

• Time to First Culture Negative Sputum Sample (LJ Solid Media)

  18 months

• Time to First Culture Negative Sputum Sample (MGIT Liquid Media)

  18 months

Study Arms (3)

Regimen 1 - 2EHRZ/4HR (control regimen)

PLACEBO COMPARATOR

* Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by * Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by * Nine weeks of Isoniazid and Rifampicin only.

Drug: Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin

Regimen 2 - 2MHRZ/2MHR

EXPERIMENTAL

* Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by * Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by * Nine weeks of the Isoniazid placebo and the Rifampicin placebo.

Drug: Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin

Regimen 3 - 2EMRZ/2MR

EXPERIMENTAL

* Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by * Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by * Nine weeks of the Isoniazid placebo and the Rifampicin placebo

Drug: Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin

Interventions

Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin DRUG

Moxifloxacin 400 mg Rifampicin \< 45 kg 450 mg \> 45 kg 600 mg Isoniazid 300 mg Pyrazinamide \< 40 kg 25 mg/kg rounded to nearest 500 mg\* 40-55 kg 1000 mg \> 55 kg - 75 kg 1500 mg \> 75 kg 2000 mg Ethambutol \< 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg \> 55 kg - 75 kg 1200 mg \> 75 kg 1600 mg \*For pyrazinamide dosing in patients \< 40 kg, 1000 mg used instead of 500 mg All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.

Also known as: Avelox, Avelon, Avalox, Myambutol, Nydrazid, Rifampin, Rifadin

Regimen 1 - 2EHRZ/4HR (control regimen); Regimen 2 - 2MHRZ/2MHR; Regimen 3 - 2EMRZ/2MR

Eligibility Criteria

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

You may qualify if:

• Signed written consent or witnessed oral consent in the case of illiteracy, before undertaking any trial related activity.
• Two sputum specimens positive for tubercle bacilli on smear microscopy at least one of which must be processed and positive at the study laboratory.
• Aged 18 years or over.
• No previous anti-tuberculosis chemotherapy.
• A firm home address 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.
• Agreement to participate in the study and to give a sample of blood for HIV testing (see appendices 1 \& 2).
• Pre-menopausal women must be using a barrier form of contraception or be surgically sterilised or have an IUCD in place.
• Laboratory parameters performed up to 14 days before enrolment.
• Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal.
• Serum total bilirubin level less than 2.5 times upper limit of normal. Creatinine clearance (CrCl) level greater than 30 mls/min.
• Haemoglobin level of at least 7.0 g/dL.
• Platelet count of at least 50x109cells/L.
• Serum potassium greater than 3.5 mmol/L.
• Negative pregnancy test (women of childbearing potential).

You may not qualify if:

• Unable to take oral medication.
• Previously enrolled in this study.
• Received any investigational drug in the past 3 months.
• Received an antibiotic active against M. tuberculosis in the last 14 days (fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
• Any condition that may prove fatal during the first two months of the study period.
• TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome
• Pre-existing non-tuberculosis disease e.g. diabetes, liver or kidney disease, blood disorders,peripheral neuritis, chronic diarrhoeal disease in which the current clinical condition of the patient is likely to prejudice the response to, or assessment of treatment.
• Pregnant or breast feeding.
• Suffering from a condition likely to lead to uncooperative behaviour e.g. psychiatric illness or alcoholism.
• Contraindications to any medications in the study regimens.
• Known to have congenital or sporadic syndromes of QTc prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine).
• Known allergy to any fluoroquinolone antibiotic or history of tendinopathy associated with quinolones.
• Patients already receiving anti-retroviral therapy.
• Patients whose initial isolate is shown to be multiple drug resistant (i.e. resistant to rifampicin and isoniazid) or monoresistant to rifampicin, or resistant to any fluoroquinolone)
• Weight less than 35kg

Sponsors & Collaborators

• Global Alliance for TB Drug Development: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• University College, London: collaborator
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator
• Sanofi: collaborator

Study Sites (47)

Beijing Tuberculosis and Thoracic Tumor Research Institute

Beijing, 101149, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

TB Institute

Tianjin, 300041, China

Location

Nirmal Kumar Jain

Jaipur, Rajasthan, India

Location

Mahatma Gandhi Medical College& Hospital

Jaipur, Rajsthan, India

Location

Ram-Tej Hospital,

Agra, Uttar Pradesh, India

Location

Siddharth Nursing Home,

Agra, Uttar Pradesh, India

Location

Rajul Nursing Home

Aligarh, Uttar Pradesh, India

Location

Varshneya Chest Clinic & Eye Care Centre

Aligarh, Uttar Pradesh, India

Location

Dr. Neeraj Gupta Clinic

Firozabad, Uttar Pradesh, India

Location

S.P.S Chauhan Clinic

Firozabad, Uttar Pradesh, India

Location

Dr. R. K. Garg's Clinic,

Ghaziabad, Uttar Pradesh, 2011002, India

Location

Indra Nursing Home and Maternity Centre

Ghaziabad, Uttar Pradesh, India

Location

Dr. AK Singh Clinic

Kanpur, Uttar Pradesh, India

Location

Dr. S. K. Katiyar, Swaroop Nagar,

Kanpur, Uttar Pradesh, India

Location

Guru Tej Bahadur Hospital

Kanpur, Uttar Pradesh, India

Location

Dr. Komal Gupta

Lucknow, Uttar Pradesh, India

Location

New City Hospital and Trauma Centre,

Lucknow, Uttar Pradesh, India

Location

Surya Chest Foundation,

Lucknow, Uttar Pradesh, India

Location

Surya Kant Clinic

Lucknow, Uttar Pradesh, India

Location

Arya Chest Clinic, UP,India

Meerut, Uttar Pradesh, India

Location

Dr. Mahip Saluja Clinic, U.P.

Meerut, Uttar Pradesh, India

Location

Dr. S. P. Sondhi Clinic,

Meerut, Uttar Pradesh, India

Location

Sri Ram Plaza

Meerut, Uttar Pradesh, India

Location

Jigyasa Medical Center

Morādābād, Uttar Pradesh, India

Location

Saanvi MultiSpeciality Clinic,

Morādābād, Uttar Pradesh, India

Location

A-One Hospital

Delhi, 110087, India

Location

Dr. D.K. Chauhan

New Delhi, 110002, India

Location

Centre for advanced lung and sleep disorders

New Delhi, 110026, India

Location

Dr. Mittal's clinic

New Delhi, 110043, India

Location

Diligent Hospital

New Delhi, 110062, India

Location

Ish Medical Centre and Respiratory Lab,

New Delhi, India

Location

Smt Prakash Devi Memorial Medical Centre,

New Delhi, India

Location

Centre for Respiratory Disease Research at KEMRI

Nairobi, Kenya

Location

Institute of Respiratory Medicine (IPR) Jalan Pahang

Kuala Lumpur, 53000, Malaysia

Location

Hospital General de Occidente de la secretaria

Guadalajara, Seattle, 45170, Mexico

Location

Madibeng centre for Research, 40 Pienaar Street,

Madibeng, Brits, 0250, South Africa

Location

Clinical HIV Research Unit (CHRU)

Johannesburg, Westdene, 2092, South Africa

Location

Centre for TB Research and Innovation, University of Cape Town Lung Institute

Cape Town, 7700, South Africa

Location

Tiervlei Trial Center and University of Stellenbosch

Cape Town, South Africa

Location

Unit for Clinical & Biomedical TB Research, MRC Durban

Durban, South Africa

Location

NIMR Mbeya Medical Research Programme

Mbeya, Tanzania

Location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University

Khon Kaen, Mueang, 40200, Thailand

Location

Chest Disease Institute (CDI), Ministry of Public,

Nonthaburi, Mueang, 11000, Thailand

Location

Rajavithi Hospital, Division Of Pulmonary Medicine

Bangkok, Phayathai, 10400, Thailand

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (7)

• Bryant JM, Harris SR, Parkhill J, Dawson R, Diacon AH, van Helden P, Pym A, Mahayiddin AA, Chuchottaworn C, Sanne IM, Louw C, Boeree MJ, Hoelscher M, McHugh TD, Bateson AL, Hunt RD, Mwaigwisya S, Wright L, Gillespie SH, Bentley SD. Whole-genome sequencing to establish relapse or re-infection with Mycobacterium tuberculosis: a retrospective observational study. Lancet Respir Med. 2013 Dec;1(10):786-92. doi: 10.1016/S2213-2600(13)70231-5. Epub 2013 Nov 21.

  PMID: 24461758 BACKGROUND

• Friedrich SO, Rachow A, Saathoff E, Singh K, Mangu CD, Dawson R, Phillips PP, Venter A, Bateson A, Boehme CC, Heinrich N, Hunt RD, Boeree MJ, Zumla A, McHugh TD, Gillespie SH, Diacon AH, Hoelscher M; Pan African Consortium for the Evaluation of Anti-tuberculosis Antibiotics (PanACEA). Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment. Lancet Respir Med. 2013 Aug;1(6):462-70. doi: 10.1016/S2213-2600(13)70119-X. Epub 2013 Jul 1.

  PMID: 24429244 BACKGROUND

• Gillespie SH, Crook AM, McHugh TD, Mendel CM, Meredith SK, Murray SR, Pappas F, Phillips PP, Nunn AJ; REMoxTB Consortium. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426. Epub 2014 Sep 7.

  PMID: 25196020 RESULT

• Weir IR, Dufault SM, Phillips PPJ. Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial. Trials. 2024 Mar 12;25(1):180. doi: 10.1186/s13063-024-07999-w.

  PMID: 38468320 DERIVED

• Weir IR, Dufault SM, Phillips PP. Estimands for clinical endpoints in Tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial. Res Sq [Preprint]. 2023 Nov 9:rs.3.rs-3486707. doi: 10.21203/rs.3.rs-3486707/v1.

  PMID: 37986887 DERIVED

• Rachow A, Saathoff E, Mtafya B, Mapamba D, Mangu C, Rojas-Ponce G, Ntinginya NE, Boeree M, Heinrich N, Gillespie SH, Hoelscher M; PanACEA-Consortium. The impact of repeated NALC/NaOH- decontamination on the performance of Xpert MTB/RIF assay. Tuberculosis (Edinb). 2018 May;110:56-58. doi: 10.1016/j.tube.2018.04.001. Epub 2018 Apr 5.

  PMID: 29779774 DERIVED

• Phillips PP, Mendel CM, Burger DA, Crook AM, Nunn AJ, Dawson R, Diacon AH, Gillespie SH. Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. BMC Med. 2016 Feb 4;14:19. doi: 10.1186/s12916-016-0565-y.

  PMID: 26847437 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Moxifloxacin; Ethambutol; Isoniazid; Pyrazinamide; Rifampin

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Hydrazines; Isonicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Daniel E. Everitt, MD, Vice President and Senior Medical Officer
• Organization: Global Alliance for TB Drug Development

Dan.Everitt@tballiance.org

(212) 227-7540

Study Officials

• Stephen H Gillespie, MB BCh BAO MD DSc

  University of St Andrews

  STUDY DIRECTOR

• Andrew Nunn, BSc MSc

  MRC Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

• Sarah K Meredith, MB BS MSc

  MRC Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

• Timothy D McHugh, BSc PhD CSi

  Centre for Medical Microbiology, Royal Free and University College Medical School

  PRINCIPAL INVESTIGATOR

• Ali Zumla, BSc MBChB MSc PhD

  Centre for International Health, Royal Free and University College Medical School

  PRINCIPAL INVESTIGATOR

• Alexander Pym, MB BMRCP PhD

  Unit for Clinical & Biomedical TB Research, MRC Durban

  PRINCIPAL INVESTIGATOR

• Peter Mwaba, MB ChB MMed PhD

  University Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Noel Sam, MMed MD

  Kilimanjaro Christian Medical Centre

  PRINCIPAL INVESTIGATOR

• Andreas Diacon, BM MD

  Tiervlei Trial Center and University of Stellenbosch

  PRINCIPAL INVESTIGATOR

• Rodney Dawson, MB ChB FCP

  Centre for TB Research and Innovation, UCT Lung Institute

  PRINCIPAL INVESTIGATOR

• Evans Amukoye, MBChB. Mmed (Paediatric)

  Centre for Respiratory Disease Research at KEMRI

  PRINCIPAL INVESTIGATOR

• Leonard Maboko, MD MSc PhD

  NIMR - Mbeya Medical Research Programme

  PRINCIPAL INVESTIGATOR

• Ian Sanne, MBBCH FCP(SA)

  Clinical HIV Research Unit (CHRU), Westdene

  PRINCIPAL INVESTIGATOR

• Cheryl Louw, MBChB

  Madibeng Centre For Research, Brits

  PRINCIPAL INVESTIGATOR

• Mengqui Gao, MD

  Beijing Tuberculosis and Thoracic Tumor Research Institute

  PRINCIPAL INVESTIGATOR

• Qing Zhang, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Xiexiu Wang, MD

  TB Institute, Tianjin

  PRINCIPAL INVESTIGATOR

• Aziah Mahayiddin, MD

  Institute of Respiratory Medicine (IPR) Jalan Pahang, Malaysia

  PRINCIPAL INVESTIGATOR

• Watchara Boonsawat, MD PhD

  Srinagarind Hospital, Division of Pulmonary Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

• Charoen Chuchottaworn, MD

  Chest Disease Institute (CDI), Ministry of Public Health, Nonthaburi

  PRINCIPAL INVESTIGATOR

• Pairaj Kateruttanakul, MD

  Rajavithi Hospital, Division of Pulmonary, Department of Medicine, Bangkok

  PRINCIPAL INVESTIGATOR

• Gerardo Amaya-Tapia, MD

  Hospital General de occidente de la secretaria, Seattle, Mexico

  PRINCIPAL INVESTIGATOR

• Stephen Murray, M.D, PhD

  Global Alliance for TB Drug Development

  PRINCIPAL INVESTIGATOR

• Michael Brown, BA, BM, BCh, MRCP, PhD, DTM&H

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Rakesh Lal, MD

  Centre for Advanced Lung and Sleep Disorders, New Delhi, India

  PRINCIPAL INVESTIGATOR

• Rakesh Mittal, MBBS MD

  Dr. Mittal's Clinic, Balaji Medical Store, New Delhi, India

  PRINCIPAL INVESTIGATOR

• A K Jain, MBBS FICA

  Diligent Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

• Mahesh Kapoor, MBBS DTCD

  A One Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

• D K Chauhan, MBBS

  Dr D.K. Chauhan, New Delhi, India

  PRINCIPAL INVESTIGATOR

• Mahip Saluja, M.D

  Dr. Mahip Saluja Clinic, Meerut, U.P. India

  PRINCIPAL INVESTIGATOR

• Neeraj Gupta, MD

  Dr. Neeraj Gupta, Firozabad ,U.P, India

  PRINCIPAL INVESTIGATOR

• Subodh Katiyar, MD

  Dr Subodh, Swaroop Nagar,Kanpur, India

  PRINCIPAL INVESTIGATOR

• Nirmal K Jain, MD

  Dr.Nirmal Kumar Jain, Jaipur, India

  PRINCIPAL INVESTIGATOR

• Komal Gupta, M.D

  Kilkari , Lucknow , India

  PRINCIPAL INVESTIGATOR

• Fahad Khan, MD

  New City Hospital and Trauma Centre, Lucknow, India

  PRINCIPAL INVESTIGATOR

• Vaibhav Gupta, MD

  Saanvi MultiSpeciality Clinic, Moradabad, UP, India,

  PRINCIPAL INVESTIGATOR

• Suraj P Sondhi, MD

  Dr. S. P. Sondhi Clinic , Meerut U.P India

  PRINCIPAL INVESTIGATOR

• Siddharth Agarwal, MD

  Siddharth Nursing Home, Agra, U.P India

  PRINCIPAL INVESTIGATOR

• Sanjay Teotia, M.D

  Dr. Sanjay Teotia Clinic, Meerut, U.P , India

  PRINCIPAL INVESTIGATOR

• S PS Chauhan, MD

  Dr. SPS Chauhan, Firozabad, U.P-India,

  PRINCIPAL INVESTIGATOR

• Mahesh Mishra, MD

  Mahatma Gandhi Medical College& Hospital , Jaipur, India

  PRINCIPAL INVESTIGATOR

• Ashish Rohatgi, DTCD

  Ish Medical Centre and Respiratory Lab, New Delhi- India

  PRINCIPAL INVESTIGATOR

• Om P Rai, MD

  Guru Tej Bahadur Hospital, Kanpur India

  PRINCIPAL INVESTIGATOR

• Pawan Varshneya, MD

  Varshneya Chest Clinic & Eye Care Centre, Aligarh, UP India

  PRINCIPAL INVESTIGATOR

• R K Garg, MD

  Dr. R. K. Garg's Clinic, U.P, India

  PRINCIPAL INVESTIGATOR

• Vinod K Karhana, M.D

  Prakash Devi Memorial Medical Centre,New Delhi, India

  PRINCIPAL INVESTIGATOR

• Vijay K Khurana, M.D

  Ram-Tej Hospital, Agra, India

  PRINCIPAL INVESTIGATOR

• Surya Kant, MD, FCCP, FNCP, FCAI

  Dr.Surya Kant, Lucknow, India

  PRINCIPAL INVESTIGATOR

• Shalini Arya, MD

  Arya Chest Clinic, Meerut, UP,India

  PRINCIPAL INVESTIGATOR

• Ashok K Singh, MD, FCCP, FCCS

  Pulmonary Care and Sleep Clinic, Kanpur, India

  PRINCIPAL INVESTIGATOR

• Bhanu P Singh, MD, FCCP

  Surya Chest Foundation, Lucknow India

  PRINCIPAL INVESTIGATOR

• Chandra P Singh, MD

  Jigyasa Medical Center,Uttar Pradesh, India

  PRINCIPAL INVESTIGATOR

• Arun Aggarwal, MD

  Indra Nursing Home and Maternity Centre, Uttar Pradesh, India

  PRINCIPAL INVESTIGATOR

• Anjula Bhargava, MS

  Rajul Nursing Home, Sasni Gate, Aligarh, UP India

  PRINCIPAL INVESTIGATOR

• Angela Crook

  MRC Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

• Salome Charalambous

  The Aurum Institute, Tembisa Hospital, South Africa

  PRINCIPAL INVESTIGATOR

• Lerato Mohapi

  Soweto Perinatal HIV Research Unit, Johannesburg, South Africa

  PRINCIPAL INVESTIGATOR

• Nesri Padayatchi

  Caprisa eThakwini Research Facility, Durban, South Africa

  PRINCIPAL INVESTIGATOR

• Sandy Pillay

  International Clinical Trials Unit, Durban, South Africa

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: January 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 21, 2017
• Results First Posted: May 25, 2015

Record last verified: 2017-02

Locations

ZA (1); IN (30); TA (2); KE (1); TH (3); CN (3); ME (1); MY (1)