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Trial record 6 of 39 for:    " February 17, 2010":" March 19, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Conditions HIV
HIV Infections
Interventions Drug: Efavirenz
Drug: Over-encapsulated efavirenz
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Efavirenz First, Then Over-encapsulated Efavirenz Over-encapsulated Efavirenz First, Then Efavirenz
Hide Arm/Group Description This arm received efavirenz for five days, then over-encapsulated efavirenz for five days. This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
Period Title: First Intervention (5 Days)
Started 8 7
Completed 5 6
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             3             1
Period Title: Second Intervention (5 Days)
Started 5 6
Completed 4 6
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Efavirenz Over-encapsulated Efavirenz Total
Hide Arm/Group Description Both arms received both versions of the drug during the course of the study. Both arms received both versions of the drug over the course of the study. Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
7
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
26.125  (8.45893) 25.875  (2.53194) 26  (6.03324)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
6
  75.0%
4
  57.1%
10
  66.7%
Male
2
  25.0%
3
  42.9%
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 15 participants
8 7 15
1.Primary Outcome
Title Serum Levels of Efavirenz
Hide Description Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.
Time Frame 5th day of taking drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Efavirenz (Tablet) Over-encapsulated Efavirenz
Hide Arm/Group Description:
All subjects took efavirenz.
All subjects took over-encapsulated efavirenz.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
5151.11  (765.67) 4965.08  (1285.48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Efavirenz Over-encapsulated Efavirenz
Hide Arm/Group Description Both arms received both versions of the drug during the course of the study. Both arms received both versions of the drug over the course of the study.
All-Cause Mortality
Efavirenz Over-encapsulated Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Efavirenz Over-encapsulated Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Efavirenz Over-encapsulated Efavirenz
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ann Seguin
Organization: University of Minnesota
Phone: 612-625-7472
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01087814     History of Changes
Other Study ID Numbers: 0910M73917
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: November 7, 2011
Results First Posted: September 12, 2014
Last Update Posted: March 9, 2017