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Sustiva Levels With Use of a Gel Capsule

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; HIV Infections

Intervention: Efavirenz (Drug); Over-encapsulated efavirenz (Drug)

Phase: Phase 4

Status: Completed

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

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

University of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information

Starting date: February 2010
Last updated: September 5, 2014

Page last updated: August 23, 2015

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