Triomune Bioequivalence With Innovators
This study has been completed.
Sponsor:
Makerere University
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
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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
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 | |
|---|---|
|
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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