Contact information
Type
Scientific
Primary contact
Mr Edward Mills
ORCID ID
Contact details
Director of Research
Canadian College of Naturopathic Medicine
1255 Sheppard Ave East
North York
Ontario
M2K 1E2
Canada
+1 416 498 1255 ext 324
emills@ccnm.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Drug interactions
Intervention
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.
Intervention type
Drug
Phase
Phase I
Drug names
Milk thistle, indinavir
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
24
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Director of Research, Canadian College of Naturopathic Medicine
North York, Ontario
M2K 1E2
Canada
Sponsor information
Organisation
Ontario HIV Treatment Network
Sponsor details
1300 Yonge Street
Suite 308
Toronto
Ontario
M4T 1X3
Canada
+1 416 642 6486<BR/>Toll Free: +1 877 743 6486
info@ohtn.on.ca
Sponsor type
Not defined
Website
Funders
Funder type
Research organisation
Funder name
Ontario HIV Treatment Network (Canada)
Alternative name(s)
OHTN
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15666173
Publication citations
-
Results
Mills E, Wilson K, Clarke M, Foster B, Walker S, Rachlis B, DeGroot N, Montori VM, Gold W, Phillips E, Myers S, Gallicano K, Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis., Eur. J. Clin. Pharmacol., 2005, 61, 1, 1-7, doi: 10.1007/s00228-004-0843-z.