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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00455585
First Posted: April 3, 2007
Last Update Posted: February 8, 2008
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:
Department of Foreign Affairs, Ireland
Information provided by:
Makerere University
  Purpose
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
Intervention Model: Crossover Assignment
Masking: None (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)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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): NCT00455585


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

Publications:
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
ClinicalTrials.gov Identifier: NCT00455585     History of Changes
Other Study ID Numbers: CPR001
First Submitted: April 2, 2007
First Posted: April 3, 2007
Last Update Posted: February 8, 2008
Last Verified: February 2008

Keywords provided by Makerere University:
Pharmacokinetics
Antiretrovirals
Uganda
HIV
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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