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Triomune Bioequivalence With Innovators

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025830
First Posted: December 4, 2009
Last Update Posted: January 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Francisco
Information provided by:
Makerere University
April 21, 2009
December 4, 2009
April 21, 2009
December 4, 2009
January 5, 2010
February 2006
June 2006   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01025830 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Triomune Bioequivalence With Innovators
Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-infected Ugandan Adults
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV/AIDS
  • Drug: Triomune
    Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day
    Other Names:
    • Stavudine
    • Lamivudine
    • Nevirapine
  • Drug: Zerit/Epivir/Viramune
    Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.
    Other Names:
    • Stavudine
    • Lamivudine
    • Nevirapine
  • Experimental: Generic
    generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune)
    Intervention: Drug: Triomune
  • Active Comparator: Brand
    3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine)
    Intervention: Drug: Zerit/Epivir/Viramune
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. doi: 10.1371/journal.pone.0003981. Epub 2008 Dec 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2008
June 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
 
NCT01025830
BETr
No
Not Provided
Not Provided
Jayne Tusiime, University of California, Berkeley
Makerere University
University of California, San Francisco
Principal Investigator: Jayne Tusiime, B Pharm, MSc Makerere University
Study Chair: David R Bangsberg, MD,MPH Harvard University
Makerere University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP