Botanical/Drug Interactions in HIV: Glucuronidation

National Institutes of Health (NIH)

Status and phase

Completed

Phase 1

Conditions

HIV Seronegativity

Treatments

Drug: silymarin

Study type

Interventional

Funder types

NIH

Identifiers

NCT00065741

R21AT001376-01A1

Details and patient eligibility

About

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.

Full description

As per Brief Summary

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.