Clinical trial NCT00065741: Botanical/Drug Interactions in HIV: Glucuronidation
Official title: Botanical/Drug Interactions in HIV: Glucuronidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Seronegativity
Keywords: Milk thistle
silymarin
piperine
glucarate
zidovudine
abacavir
mycophenolate mofetil
HIV
pharmacokinetics
interaction
glucuronidation
Healthy
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: School of Pharmacy, UNC Chapel Hill
name: Philip C Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill
name: David A Wohl, MD
role: STUDY_DIRECTOR
References: