Sustiva Levels With Use of a Gel Capsule

January 26, 2017 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: efavirenz
Drug: Efavirenz
Subject will take efavirenz for 5 days.
Other Names:
  • 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 Names:
  • Over-encapsulated Sustiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5th day of taking drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Timothy W Schacker, M.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0910M73917

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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