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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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

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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.
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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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Limitations and Caveats

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More Information

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