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Botanical/Drug Interactions in HIV: Glucuronidation

NCT00065741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-03-23

No results posted yet for this study

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

Interventions

DRUG

silymarin

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Philip C Smith, PhD · School of Pharmacy, UNC Chapel Hill

  • David A Wohl, MD · Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Completion
2006-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00065741 on ClinicalTrials.gov