CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Efavirenz +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01087814
NCT01087814Phase 4Completed
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Effect of Encapsulation Upon Efavirenz Pharmacokinetics

University of Minnesota·interventional·Posted Mar 16, 2010·Updated Mar 9, 2017

In Brief

A Phase 4 clinical trial evaluating Efavirenz and Over-encapsulated efavirenz for HIV and HIV Infections. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2010
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.3 years ago

Interventions

Efavirenzdrug

Subject will take efavirenz for 5 days.

Over-encapsulated efavirenzdrug

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