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Sustiva Levels With Use of a Gel Capsule

NCT01087814 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-03-09

Study results available
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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.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

Efavirenz

Subject will take efavirenz for 5 days.

DRUG

Over-encapsulated efavirenz

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

Sponsors & Collaborators

Principal Investigators

  • Timothy W Schacker, M.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087814 on ClinicalTrials.gov