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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

About this trial

This is an interventional basic science trial for HIV focused on measuring efavirenz, Sustiva, pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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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