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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00065741 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Seronegativity |
Drug: silymarin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Botanical/Drug Interactions in HIV: Glucuronidation |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Absence of HIV-1 infections
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| General Clinical Research Center, Univiversity Of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Philip C Smith, PhD | School of Pharmacy, UNC Chapel Hill |
| Study Director: | David A Wohl, MD | Department of Medicine, AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill |
More Information
| ClinicalTrials.gov Identifier: | NCT00065741 History of Changes |
| Other Study ID Numbers: | R21 AT001376-01A1 |
| Study First Received: | July 31, 2003 |
| Last Updated: | March 21, 2007 |
| Health Authority: | United States: Federal Government |
|
Milk thistle silymarin piperine glucarate zidovudine abacavir mycophenolate mofetil |
HIV pharmacokinetics interaction glucuronidation Healthy Complementary Therapies |
|
Silymarin Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs |