Sustiva Levels With Use of a Gel Capsule
Information source: University of Minnesota - Clinical and Translational Science Institute
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; HIV Infections
Intervention: Efavirenz (Drug); Over-encapsulated efavirenz (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Minnesota - Clinical and Translational Science Institute Official(s) and/or principal investigator(s):
Timothy W Schacker, M.D., Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute
Overall contact:
Ann Seguin, M.N., Phone: 612-625-7472, Email: segu0017@umn.edu
Summary
We are studying if putting a gel capsule over a standard HIV drug changes the ability of the
body to absorb the drug. This is important because we want to be able to study new HIV drugs
against the most common drugs used today and the most common is Sustiva, which is also
called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how
much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days
and we will draw blood to see how much is absorbed.
Clinical Details
Official title: Effect of Encapsulation Upon Efavirenz Pharmacokinetics
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: Serum levels of efavirenz
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HIV-negative, proven by ELISA
- Age: ≥ 18 years old
Exclusion Criteria:
- Psychiatric or psychological illness that would make adherence to protocol procedures
unlikely.
Locations and Contacts
Ann Seguin, M.N., Phone: 612-625-7472, Email: segu0017@umn.edu
University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Ann Seguin, M.N., Phone: 612-625-7472, Email: segu0017@umn.edu
Timothy W. Schacker, M.D., Principal Investigator
Additional Information
Starting date: February 2010
Last updated: April 16, 2010
|
