Botanical/Drug Interactions in HIV: Glucuronidation

NCT ID: NCT00065741

Last Updated: 2007-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-03-31

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.

Detailed Description

As per Brief Summary

Conditions

HIV Seronegativity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

silymarin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Philip C Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Pharmacy, UNC Chapel Hill

David A Wohl, MD

Role: STUDY_DIRECTOR

Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

R21AT001376-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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