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Home > "B" Clinical Trials Conditions > Botanical/Drug Interactions in HIV: Glucuronidation  Botanical/Drug Interactions in HIV: Glucuronidation
Botanical/Drug Interactions in HIV: Glucuronidation
For Condition: HIV Seronegativity
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Absence of HIV-1 infections - Within 20% of ideal body weight - Must 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.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
PhilipSmith, Principal Investigator, School of Pharmacy, UNC Chapel Hill
General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Paul Watkins 919-966-1435
Additional Information:
Study ID Numbers: R21 AT001376-01A1;
Study Start Date: September 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065741
Other Hiv Seronegativity Studies:
1. A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
2. A Blood Test to Look at Cells of the Immune System in Healthy Children
3. Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
4. HIV Prevention Preparedness Study in Russia, China, and India
5. The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
Related Studies:
Other HIV Seronegativity Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Botanical/Drug Interactions in HIV: Glucuronidation
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