Condition category
Not Applicable
Date applied
06/11/2002
Date assigned
06/11/2002
Last edited
09/10/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

government non-federal

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15666173

Publication citations

  1. 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.

Additional files

Editorial Notes