Botanical/Drug Interactions in HIV: Glucuronidation

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065741
First received: July 31, 2003
Last updated: March 21, 2007
Last verified: March 2007

July 31, 2003
March 21, 2007
September 2003
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Complete list of historical versions of study NCT00065741 on ClinicalTrials.gov Archive Site
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Botanical/Drug Interactions in HIV: Glucuronidation
Botanical/Drug Interactions in HIV: Glucuronidation

A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.

As per Brief Summary

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Seronegativity
Drug: silymarin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2006
Not Provided

Inclusion criteria:

  • Absence of HIV-1 infections

    • Body mass index less than or equal to 30 kg/m2 and weigh at least 50 kg.
  • Laboratory values obtained within 7 days of study entry within normal range for healthy volunteers.
  • Able to be compliant with dosing schedules and diary record keeping.
  • Able to follow dietary restrictions associated with the protocol.
  • Ability and willingness to provide informed consent
  • All women of reproductive potential must have a negative pregnancy test
  • All women of reproductive potential to use contraception methods as defined by protocol
  • All study subjects (male and female) must agree to not participate in a conception process

Exclusion Criteria:

  • History of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption.
  • History of hepatic, renal, cardiovascular, gastrointestinal diseases.
  • Current gastrointestinal disturbance.
  • Receipt of any prescribed or over the counter medication or ingested CAM during the 30 days prior to study entry except: Over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines.
  • Any medical condition that, in the opinion of the investigator, would interfere with the subject’s ability to participate in this protocol.
  • Pregnancy or breastfeeding.
  • Allergy/sensitivity to study agent(s) or their formulations.
  • Active drug or alcohol abuse or dependence, which in the opinion of the investigator would interfere with adherence to study requirements or would endanger the subject’s health while on study.
  • Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days.
  • Participation in any investigational drug studies within 30 days prior to study entry and during study.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065741
R21 AT001376-01A1
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National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Philip C Smith, PhD School of Pharmacy, UNC Chapel Hill
Study Director: David A Wohl, MD Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill
National Center for Complementary and Alternative Medicine (NCCAM)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP