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	Treatment or Intervention	Phase
HIV Seronegativity	Drug: silymarin	Phase I

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion criteria:

• Absence of HIV-1 infections
• Within 20% of ideal body weight
• Must 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.

David A Wohl, MD      919-966-6712    wohl@med.unc.edu

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

Study chairs or principal investigators

Philip C Smith, PhD,  Principal Investigator,  School of Pharmacy, UNC Chapel Hill   
David A Wohl, MD,  Study Director,  Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill   

Study ID Numbers:  R21 AT001376-01A1
Record last reviewed:  July 2003
Record first received:  July 31, 2003
ClinicalTrials.gov Identifier:  NCT00065741
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20