Sustiva Levels With Use of a Gel Capsule
Primary Purpose
HIV, HIV Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Efavirenz
Over-encapsulated efavirenz
Sponsored by
About this trial
This is an interventional basic science trial for HIV focused on measuring efavirenz, Sustiva, pharmacokinetics
Eligibility 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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
efavirenz
over-encapsulated efavirenz
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01087814
First Posted
March 15, 2010
Last Updated
January 26, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01087814
Brief Title
Sustiva Levels With Use of a Gel Capsule
Official Title
Effect of Encapsulation Upon Efavirenz Pharmacokinetics
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
efavirenz, Sustiva, pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
efavirenz
Arm Type
Active Comparator
Arm Title
over-encapsulated efavirenz
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
Sustiva
Intervention Description
Subject will take efavirenz for 5 days.
Intervention Type
Drug
Intervention Name(s)
Over-encapsulated efavirenz
Other Intervention Name(s)
Over-encapsulated Sustiva
Intervention Description
Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.
Primary Outcome Measure Information:
Title
Serum Levels of Efavirenz
Description
Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.
Time Frame
5th day of taking drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy W Schacker, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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Sustiva Levels With Use of a Gel Capsule
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