Triomune Bioequivalence With Innovators
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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 21, 2009 | ||||||||
| Last Updated Date | December 31, 2009 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01025830 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Triomune Bioequivalence With Innovators | ||||||||
| Official Title ICMJE | Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-infected Ugandan Adults | ||||||||
| Brief Summary | The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans. This is a non-inferiority study. |
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| Detailed Description | Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of Lamivudine, Stavudine and Nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®). An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received Lamivudine (150 mg), Stavudine (40 mg), and Nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0-12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand-name within the 90% confidence interval of 0.8-1.25. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | HIV/AIDS | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Byakika-Tusiime J, Chinn LW, Oyugi JH, Obua C, Bangsberg DR, Kroetz DL. Steady state bioequivalence of generic and innovator formulations of stavudine, lamivudine, and nevirapine in HIV-infected Ugandan adults. PLoS One. 2008;3(12):e3981. Epub 2008 Dec 19. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | March 2008 | ||||||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Uganda | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01025830 | ||||||||
| Other Study ID Numbers ICMJE | BETr | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jayne Tusiime, University of California, Berkeley | ||||||||
| Study Sponsor ICMJE | Makerere University | ||||||||
| Collaborators ICMJE | University of California, San Francisco | ||||||||
| Investigators ICMJE |
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| Information Provided By | Makerere University | ||||||||
| Verification Date | December 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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