Comparison of Plasma Drug Levels of Triomune 40 With Those of the Originator Products
This study has been completed.
Sponsor:
Makerere University
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
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 |
| 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
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.
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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases 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 May 23, 2013