Comparison of Plasma Drug Levels of Triomune 40 With Those of the Originator Products

This study has been completed.
Department of Foreign Affairs, Ireland
Information provided by:
Makerere University Identifier:
First received: April 2, 2007
Last updated: February 7, 2008
Last verified: February 2008
This study aims to compare the steady state pharmacokinetics of stavudine, lamivudine, and nevirapine in HIV positive Ugandan patients taking Triomune 40 with the pharmacokinetics of the originator products known as Viramune, Epivir and Zerit 40.

Condition Intervention Phase
HIV Infections
Drug: nevirapine, stavudine, lamivudine
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: Comparison of the Steady State Pharmacokinetics of Nevirapine, Stavudine Plus Lamivudine in HIV Positive Ugandan Patients Taking Triomune 40 With the Pharmacokinetics of the Originator Products.

Resource links provided by NLM:

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Pharmacokinetics of nevirapine, stavudine and lamivudine

Secondary Outcome Measures:
  • Safety aand tolerability of nevirapine, stavudine and lamivudine
  • Pharmacogenomics of Ugandan subjects

Estimated Enrollment: 18
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over eighteen years Ability to provide full informed written consent Confirmed diagnosis of HIV infection On ARV therapy with Triomune 40

Exclusion Criteria:

  • Haemoglobin < 8g/dl Liver and renal function tests > 3 times the upper limit of normal Pregnancy Use of know inhibitors or inducers of cytochrome P450 or P-glycoprotein. Use of herbal medications Weight <60kg Intercurrent illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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 identifier: NCT00455585

Makerere University, Infectious Diseases Insititute
Kampala, Uganda, 22418
Sponsors and Collaborators
Makerere University
Department of Foreign Affairs, Ireland
Principal Investigator: Concepta Merry, PhD Trinity College Dublin
Study Director: Keith McAdam Infectious Diseases Institute, Makerere University
  More Information

JA Gogtay, V.M., VG Nayak, PV Bodhe, A Dasgupta, V Srivatsan, G Vaidyanathan, KC Patel. A pharmacokinetic evaluation of lamivudine, stavudine and nevirapine given as a fixed dose combination pill versus the same three drugs given safely in healthy human volunteers. in 6th International Congress on Drug Therapy in HIV Infection. 2002. Glasgow,UK. 16.
Hosseinipour M C, C.A., Kanyama C, Mshali I. Pharmacokinetic Comparison of Generic and Trade Formulations of Lamivudine, Stavudine and Nevirapine in HIV-infected Malawian Subjects. in 12th Conference on Retroviruses and Opportunistic Infections. 2005. Boston. 17.

Responsible Party: Concepta Merry, Infectious Diseases Institute Identifier: NCT00455585     History of Changes
Other Study ID Numbers: CPR001 
Study First Received: April 2, 2007
Last Updated: February 7, 2008
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Treatment Experienced

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors processed this record on May 26, 2016