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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV/AIDS |
Drug: Triomune Drug: Zerit/Epivir/Viramune |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-infected Ugandan Adults |
Resource links provided by NLM:
Further study details as provided by Makerere University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 20 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Generic
generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune)
|
Drug: Triomune
Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day
Other Names:
|
|
Active Comparator: Brand
3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine)
|
Drug: Zerit/Epivir/Viramune
Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-infected men and non-pregnant women;
- On Triomune for at least 4 weeks;
- 18 years or greater;
- Residing within 15km of Kampala city center
Exclusion Criteria:
- Unable to sign or understand informed consent
- Concurrent medication known to interact with any of the components of Triomune
- Patients with active TB, malabsorption, nausea, emesis, abdominal discomfort, chronic diarrhoea, documented active clinically relevant hepatitis;
- Patients expected to change their drug regimen or dosage during the study
- Those planning to move out of Kampala in the next two months;
- Hemoglobin <7.0 mmol/l (men) or <6.5 mmol/l (women);
- Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal;
- Serum creatinine > 1.5 times the upper limit of normal
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025830
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025830
Locations
| Uganda | |
| Makerere University | |
| Kampala, Uganda | |
Sponsors and Collaborators
Makerere University
University of California, San Francisco
Investigators
| Principal Investigator: | Jayne Tusiime, B Pharm, MSc | Makerere University |
| Study Chair: | David R Bangsberg, MD,MPH | Harvard University |
More Information
Publications:
| Responsible Party: | Jayne Tusiime, University of California, Berkeley |
| ClinicalTrials.gov Identifier: | NCT01025830 History of Changes |
| Other Study ID Numbers: |
BETr |
| Study First Received: | April 21, 2009 |
| Results First Received: | April 21, 2009 |
| Last Updated: | December 31, 2009 |
Keywords provided by Makerere University:
|
HIV;Bioequivalence;Triomune |
Additional relevant MeSH terms:
|
Lamivudine Nevirapine Stavudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Antimetabolites |
ClinicalTrials.gov processed this record on May 25, 2017