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Triomune Bioequivalence With Innovators

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ClinicalTrials.gov Identifier: NCT01025830
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : December 4, 2009
Last Update Posted : January 5, 2010
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Makerere University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV/AIDS
Interventions: Drug: Triomune
Drug: Zerit/Epivir/Viramune

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from an ongoing cohort study in Kampala, Uganda. The first subject was recruited in Feb 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received a medical and laboratory examination before assignment. Subjects were excluded if they had active tuberculosis or were anemic. 22 participants were recruited; 22 were screened,2 were excluded (1 did not meet inclusion criteria and 1 refused participation).

Reporting Groups
  Description
Generic (Triomune) to Brand (Zerit/Epivir/Viramune) Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
Brand (Zerit/Epivir/Viramune) to Generic (Triomune) started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)

Participant Flow for 3 periods

 Period 1:   Generic (Tr) First Then Brand (Ze/Ep/Vi)
    Generic (Triomune) to Brand (Zerit/Epivir/Viramune)   Brand (Zerit/Epivir/Viramune) to Generic (Triomune)
STARTED   8   12 
COMPLETED   8   12 
NOT COMPLETED   0   0 

Period 2:   Washout Period of 30 Days
    Generic (Triomune) to Brand (Zerit/Epivir/Viramune)   Brand (Zerit/Epivir/Viramune) to Generic (Triomune)
STARTED   8   12 
COMPLETED   8   12 
NOT COMPLETED   0   0 

Period 3:   Brand (Ze/Ep/Vi) First Then Generic (Tr)
    Generic (Triomune) to Brand (Zerit/Epivir/Viramune)   Brand (Zerit/Epivir/Viramune) to Generic (Triomune)
STARTED   8   12 
COMPLETED   8   12 
NOT COMPLETED   0   0 



  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
Entire Study Population Includes groups randomized to receive generic formulation and brand formulation

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information