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Botanical/Drug Interactions in HIV: Glucuronidation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00065741
Recruitment Status : Completed
First Posted : August 1, 2003
Last Update Posted : March 23, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Seronegativity Drug: silymarin Phase 1

Detailed Description:
As per Brief Summary

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Botanical/Drug Interactions in HIV: Glucuronidation
Study Start Date : September 2003
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Silymarin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Center for Complementary and Integrative Health (NCCIH)
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

ClinicalTrials.gov Identifier: NCT00065741     History of Changes
Other Study ID Numbers: R21AT001376-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2003    Key Record Dates
Last Update Posted: March 23, 2007
Last Verified: March 2007

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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
Protective Agents
Physiological Effects of Drugs