Sustiva Levels With Use of a Gel Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01087814
First received: March 15, 2010
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: November 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Basic Science
Conditions: HIV
HIV Infections
Interventions: Drug: Efavirenz
Drug: Over-encapsulated efavirenz

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Efavirenz First, Then Over-encapsulated Efavirenz This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
Over-encapsulated Efavirenz First, Then Efavirenz This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.

Participant Flow for 2 periods

Period 1:   First Intervention (5 Days)
    Efavirenz First, Then Over-encapsulated Efavirenz     Over-encapsulated Efavirenz First, Then Efavirenz  
STARTED     8     7  
COMPLETED     5     6  
NOT COMPLETED     3     1  
Withdrawal by Subject                 3                 1  

Period 2:   Second Intervention (5 Days)
    Efavirenz First, Then Over-encapsulated Efavirenz     Over-encapsulated Efavirenz First, Then Efavirenz  
STARTED     5     6  
COMPLETED     4     6  
NOT COMPLETED     1     0  
Physician Decision                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Efavirenz Both arms received both versions of the drug during the course of the study.
Over-encapsulated Efavirenz Both arms received both versions of the drug over the course of the study.
Total Total of all reporting groups

Baseline Measures
    Efavirenz     Over-encapsulated Efavirenz     Total  
Number of Participants  
[units: participants]
  8     7     15  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     7     15  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  26.125  ± 8.45893     25.875  ± 2.53194     26  ± 6.03324  
Gender  
[units: participants]
     
Female     6     4     10  
Male     2     3     5  
Region of Enrollment  
[units: participants]
     
United States     8     7     15  



  Outcome Measures

1.  Primary:   Serum Levels of Efavirenz   [ Time Frame: 5th day of taking drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: segu0017@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01087814     History of Changes
Other Study ID Numbers: 0910M73917
Study First Received: March 15, 2010
Results First Received: November 7, 2011
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board