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Sustiva Levels With Use of a Gel Capsule

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ClinicalTrials.gov Identifier: NCT01087814
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : September 12, 2014
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV HIV Infections Drug: Efavirenz Drug: Over-encapsulated efavirenz Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Encapsulation Upon Efavirenz Pharmacokinetics
Study Start Date : February 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Serum Levels of Efavirenz [ Time Frame: 5th day of taking drug ]
    Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087814


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Timothy W Schacker, M.D. University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01087814    
Other Study ID Numbers: 0910M73917
First Posted: March 16, 2010    Key Record Dates
Results First Posted: September 12, 2014
Last Update Posted: March 9, 2017
Last Verified: January 2017
Keywords provided by University of Minnesota:
efavirenz
Sustiva
pharmacokinetics
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers