Botanical/Drug Interactions in HIV: Glucuronidation

NCT00065741 | Completed Phase 1

• 1 other identifier: R21AT001376-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seronegativity

Keywords

Milk thistle; silymarin; piperine; glucarate; zidovudine; abacavir; mycophenolate mofetil; HIV; pharmacokinetics; interaction; glucuronidation; Healthy; Complementary Therapies

Interventions

silymarin DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Silymarin

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Philip C Smith, PhD

  School of Pharmacy, UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

• David A Wohl, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 31, 2003
• First Posted: August 1, 2003
• Study Start: September 1, 2003
• Study Completion: March 1, 2006
• Last Updated: March 23, 2007

Record last verified: 2007-03

Locations

US (1)