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ISRCTN
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ISRCTN78545137
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ClinicalTrials.gov identifier
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Public title
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Determining if ingestion of silybum marianum (milk thistle) influences the metabolisation of indinavir in healthy subjects: a randomised controlled phase I study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Drug interactions
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Participants - inclusion criteria
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1. Documented Enzyme-Linked Immunosorbent Assay (ELISA) and Western Blot results negative for Human Immunodeficiency Virus (HIV)
2. Aged 18 - 35 years
3. Sex male, race Caucasian, and normal findings of laboratory and physical examinations
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2003
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Anticipated end date
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31/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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24
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Interventions
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Milk thistle (silybum marianum) and indinavir.
Twenty-four healthy male participants: All individuals will receive a HIV test and Liver Function Tests (LFTs - aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT]) to exclude HIV and liver disease, and also a Complete Blood Count (CBC).
Subjects are requested to discontinue all medications, alcohol, caffeine, nicotine and other known CYP 3A4 inducers and inhibitors. Informed consent will be obtained from all participants.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Ontario HIV Treatment Network (Canada)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15666173
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Contact name
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Mr
Edward
Mills
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Address
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Director of Research, Canadian College of Naturopathic Medicine
1255 Sheppard Ave East
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City/town
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North York, Ontario
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Zip/Postcode
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M2K 1E2
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Country
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Canada
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Tel
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+1 416 498 1255 ext 324
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Fax
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+1 416 498 1643
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Email
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emills@ccnm.edu
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Sponsor
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Ontario HIV Treatment Network
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Address
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1300 Yonge Street
Suite 308
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City/town
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Toronto, Ontario
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Zip/Postcode
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M4T 1X3
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Country
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Canada
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Tel
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+1 416 642 6486<BR/>Toll Free: +1 877 743 6486
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Fax
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+1 416 640 4245
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Email
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info@ohtn.on.ca
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Date applied
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06/11/2002
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Last edited
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09/10/2007
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Date ISRCTN assigned
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06/11/2002
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