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
- 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
- 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
- All study subjects (male and female) must agree to not participate in a conception
- History of any acute or chronic illness that requires current medical therapy
including active gastrointestinal conditions that might interfere with drug
- 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.