Botanical/Drug Interactions in HIV: Glucuronidation

Phase 1

Completed

• Conditions: HIV Seronegativity

• Registration Number: NCT00065741
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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

Study Timeline

• Study First Submitted: 2003-07-31
• Study First Submitted QC: 2003-07-31
• Study First Posted: 2003-08-01
• Study Start: 2003-09
• Study Completion: 2006-03
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-21
• Last Update Posted: 2007-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States