Sustiva Levels With Use of a Gel Capsule
Effect of Encapsulation Upon Efavirenz Pharmacokinetics
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hiv
Started Feb 2010
Shorter than P25 for phase_4 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
September 12, 2014
CompletedMarch 9, 2017
January 1, 2017
7 months
March 15, 2010
November 7, 2011
January 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5th day of taking drug
Study Arms (2)
efavirenz
ACTIVE COMPARATORover-encapsulated efavirenz
EXPERIMENTALInterventions
Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.
Eligibility Criteria
You may qualify if:
- HIV-negative, proven by ELISA
- Age: ≥ 18 years old
You may not qualify if:
- Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ann Seguin
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy W Schacker, M.D.
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2010
First Posted
March 16, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2011
Last Updated
March 9, 2017
Results First Posted
September 12, 2014
Record last verified: 2017-01