Botanical/Drug Interactions in HIV: Glucuronidation

March 21, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As per Brief Summary

Study Type

Interventional

Enrollment

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

July 31, 2003

First Submitted That Met QC Criteria

July 31, 2003

First Posted (ESTIMATE)

August 1, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2007

Last Update Submitted That Met QC Criteria

March 21, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001376-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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