Sustiva Levels With Use of a Gel Capsule

Phase 4

Completed

• Conditions: HIV; HIV Infections
• Interventions: Drug: Over-encapsulated efavirenz; Drug: Efavirenz

• Registration Number: NCT01087814
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2010-09
• Study Completion: 2011-09
• Results First Submitted: 2011-11-07
• Results First Submitted QC: 2014-09-05
• Results First Posted: 2014-09-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
over-encapsulated efavirenz	Over-encapsulated efavirenz	-
efavirenz	Efavirenz	-

Primary Outcome Measures

Name	Time	Method
Serum Levels of Efavirenz	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States