Triomune Bioequivalence With Innovators
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ClinicalTrials.gov Identifier: NCT01025830 |
Recruitment Status
:
Completed
First Posted
: December 4, 2009
Results First Posted
: December 4, 2009
Last Update Posted
: January 5, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV/AIDS | Drug: Triomune Drug: Zerit/Epivir/Viramune | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
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:
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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:
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- 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 ]
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025830
Uganda | |
Makerere University | |
Kampala, Uganda |
Principal Investigator: | Jayne Tusiime, B Pharm, MSc | Makerere University | |
Study Chair: | David R Bangsberg, MD,MPH | Harvard University |
Publications of Results:
Responsible Party: | Jayne Tusiime, University of California, Berkeley |
ClinicalTrials.gov Identifier: | NCT01025830 History of Changes |
Other Study ID Numbers: |
BETr |
First Posted: | December 4, 2009 Key Record Dates |
Results First Posted: | December 4, 2009 |
Last Update Posted: | January 5, 2010 |
Last Verified: | December 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 |