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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
  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
Endpoint Classification: Bio-equivalence Study
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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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:
  • Stavudine
  • Lamivudine
  • Nevirapine
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:
  • Stavudine
  • Lamivudine
  • Nevirapine

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-infected men and non-pregnant women;
  2. On Triomune for at least 4 weeks;
  3. 18 years or greater;
  4. Residing within 15km of Kampala city center

Exclusion Criteria:

  1. Unable to sign or understand informed consent
  2. Concurrent medication known to interact with any of the components of Triomune
  3. Patients with active TB, malabsorption, nausea, emesis, abdominal discomfort, chronic diarrhoea, documented active clinically relevant hepatitis;
  4. Patients expected to change their drug regimen or dosage during the study
  5. Those planning to move out of Kampala in the next two months;
  6. Hemoglobin <7.0 mmol/l (men) or <6.5 mmol/l (women);
  7. Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal;
  8. Serum creatinine > 1.5 times the upper limit of normal
  Contacts and Locations
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
Health Authority: Uganda: Research Ethics Committee

Keywords provided by Makerere University:
HIV;Bioequivalence;Triomune

Additional relevant MeSH terms:
Nevirapine
Stavudine
Lamivudine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites

ClinicalTrials.gov processed this record on June 17, 2013