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
  Purpose

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.


Condition Intervention Phase
HIV Seronegativity
Drug: silymarin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Botanical/Drug Interactions in HIV: Glucuronidation

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 60
Study Start Date: September 2003
Estimated Study Completion Date: March 2006
Detailed Description:

As per Brief Summary

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065741

Locations
United States, North Carolina
General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065741     History of Changes
Other Study ID Numbers: R21 AT001376-01A1
Study First Received: July 31, 2003
Last Updated: March 21, 2007
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Milk thistle
silymarin
piperine
glucarate
zidovudine
abacavir
mycophenolate mofetil
HIV
pharmacokinetics
interaction
glucuronidation
Healthy
Complementary Therapies

Additional relevant MeSH terms:
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014