Sustiva Levels With Use of a Gel Capsule
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|ClinicalTrials.gov Identifier: NCT01087814|
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : September 12, 2014
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infections||Drug: Efavirenz Drug: Over-encapsulated efavirenz||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Encapsulation Upon Efavirenz Pharmacokinetics|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2011|
|Active Comparator: efavirenz||
Subject will take efavirenz for 5 days.
Other Name: 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 Name: Over-encapsulated Sustiva
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087814
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Timothy W Schacker, M.D.||University of Minnesota - Clinical and Translational Science Institute|