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Triomune Bioequivalence With Innovators

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT01025830
First received: April 21, 2009
Last updated: December 31, 2009
Last verified: December 2009
History of Changes
Results First Received: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV/AIDS
Interventions: Drug: Triomune
Drug: Zerit/Epivir/Viramune

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive generic formulation and brand formulation

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  20  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  37.4  ± 6.0  
Gender  
[units: participants]
 		 
Female     12  
Male     8  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation 		  25.1  ± 3.4  
Weight  
[units: kg]
Mean ± Standard Deviation 		  68.3  ± 6.6  



  Outcome Measures
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1.  Primary:   Area Under the Concentration-Time Curve(AUC)   [ Time Frame: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing ]
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2.  Secondary:   Maximum Plasma Concentration of Drug   [ Time Frame: Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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
Stavudine (40mg) was used whereas currently it is Stavudine(30mg) that is recommended for usage. So our results may not be applicable to patients on Stavudine 30mg.  


Results Point of Contact:  
Name/Title: Jayne Byakika Tusiime
Organization: University of California Berkeley
phone: 1 510 219 7567
e-mail: tusiimej@berkeley.edu


Publications of Results:


Responsible Party: Jayne Tusiime, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01025830     History of Changes
Other Study ID Numbers: BETr
Study First Received: April 21, 2009
Results First Received: April 21, 2009
Last Updated: December 31, 2009
Health Authority: Uganda: Research Ethics Committee