Botanical/Drug Interactions in HIV: Glucuronidation

HIV Seronegativity Clinical Trial

Official title:

Botanical/Drug Interactions in HIV: Glucuronidation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065741
• Other study ID #: R21AT001376-01A1
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2003
• Last updated: March 21, 2007
• Start date: September 2003
• Est. completion date: March 2006

Study information

• Verified date: March 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

As per Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Seronegativity

Intervention

Drug:
• silymarin

Locations

Country	Name	City	State
United States	General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,