Sustiva Levels With Use of a Gel Capsule

HIV Infections Clinical Trial

Official title:

Effect of Encapsulation Upon Efavirenz Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087814
• Other study ID #: 0910M73917
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2010
• Last updated: September 5, 2014
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• Efavirenz
Subject will take efavirenz for 5 days.
• Over-encapsulated efavirenz
Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Levels of Efavirenz	Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.	5th day of taking drug	No