Botanical/Drug Interactions in HIV: Glucuronidation
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ClinicalTrials.gov Identifier: NCT00065741 |
Recruitment Status
:
Completed
First Posted
: August 1, 2003
Last Update Posted
: March 23, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Seronegativity | Drug: silymarin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Completion Date : | March 2006 |


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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, North Carolina | |
General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 |
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 |
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 |