Triomune Bioequivalence With Innovators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01025830
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : December 4, 2009
Last Update Posted : January 5, 2010
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
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 

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 

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 

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

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 37.4  (6.0) 
[Units: Participants]
Female   12 
Male   8 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 25.1  (3.4) 
[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 ]

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 ]

  Serious Adverse Events

  Other Adverse Events

  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.

  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: Jayne Byakika Tusiime
Organization: University of California Berkeley
phone: 1 510 219 7567

Publications of Results:

Responsible Party: Jayne Tusiime, University of California, Berkeley Identifier: NCT01025830     History of Changes
Other Study ID Numbers: BETr
First Submitted: April 21, 2009
First Posted: December 4, 2009
Results First Submitted: April 21, 2009
Results First Posted: December 4, 2009
Last Update Posted: January 5, 2010