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

This study has been completed.

Sponsor:

Collaborator:

Department of Foreign Affairs, Ireland

Information provided by:

Makerere University

ClinicalTrials.gov Identifier:

NCT00455585

First received: April 2, 2007

Last updated: February 7, 2008

Last verified: February 2008

History of Changes

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 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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Stavudine Nevirapine Lamivudine

U.S. FDA Resources

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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 ClinicalTrials.gov identifier: 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.

Laurent C, Kouanfack C, Koulla-Shiro S, Nkoué N, Bourgeois A, Calmy A, Lactuock B, Nzeusseu V, Mougnutou R, Peytavin G, Liégeois F, Nerrienet E, Tardy M, Peeters M, Andrieux-Meyer I, Zekeng L, Kazatchkine M, Mpoudi-Ngolé E, Delaporte E. Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial. Lancet. 2004 Jul 3-9;364(9428):29-34.

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
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:


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

ClinicalTrials.gov processed this record on September 23, 2016

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