Sustiva Levels With Use of a Gel Capsule

NCT ID: NCT01087814

Last Updated: 2017-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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efavirenz

Group Type ACTIVE_COMPARATOR

Efavirenz

Intervention Type DRUG

Subject will take efavirenz for 5 days.

over-encapsulated efavirenz

Group Type EXPERIMENTAL

Over-encapsulated efavirenz

Intervention Type DRUG

Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.

Interventions

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Efavirenz

Subject will take efavirenz for 5 days.

Intervention Type DRUG

Over-encapsulated efavirenz

Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.

Intervention Type DRUG

Other Intervention Names

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Sustiva Over-encapsulated Sustiva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy W Schacker, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0910M73917

Identifier Type: -

Identifier Source: org_study_id

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