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Sustiva Levels With Use of a Gel Capsule

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01087814
First received: March 15, 2010
Last updated: July 25, 2011
Last verified: July 2011
History of Changes

March 15, 2010
July 25, 2011
February 2010
September 2010   (final data collection date for primary outcome measure)
Serum levels of efavirenz [ Time Frame: 5th day of taking drug ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01087814 on ClinicalTrials.gov Archive Site
Not Provided
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Sustiva Levels With Use of a Gel Capsule
Effect of Encapsulation Upon Efavirenz Pharmacokinetics

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
  • HIV
  • HIV Infections
  • Drug: Efavirenz
    Subject will take efavirenz for 5 days.
    Other Name: Sustiva
  • Drug: Over-encapsulated efavirenz
    Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.
    Other Name: Over-encapsulated Sustiva
  • Active Comparator: efavirenz
    Intervention: Drug: Efavirenz
  • Experimental: over-encapsulated efavirenz
    Intervention: Drug: Over-encapsulated efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
February 2012
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01087814
0910M73917
No
Timothy W. Schacker, M.D., University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Timothy W Schacker, M.D. University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP