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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
  Purpose

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.


Condition Intervention Phase
HIV
HIV Infections
 Drug: Efavirenz
Drug: Over-encapsulated efavirenz
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Encapsulation Upon Efavirenz Pharmacokinetics

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Serum levels of efavirenz [ Time Frame: 5th day of taking drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: efavirenz Drug: Efavirenz
Subject will take efavirenz for 5 days.
Other Name: Sustiva
Experimental: over-encapsulated efavirenz 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087814

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Timothy W Schacker, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Timothy W. Schacker, M.D., University of Minnesota
ClinicalTrials.gov Identifier: NCT01087814     History of Changes
Other Study ID Numbers: 0910M73917
Study First Received: March 15, 2010
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
efavirenz
Sustiva
pharmacokinetics

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013