Comparison of Plasma Drug Levels of Triomune 40 With Those of the Originator Products
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ClinicalTrials.gov Identifier: NCT00455585 |
Recruitment Status
:
Completed
First Posted
: April 3, 2007
Last Update Posted
: February 8, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: nevirapine, stavudine, lamivudine | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 18 participants |
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. |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | November 2007 |

- Pharmacokinetics of nevirapine, stavudine and lamivudine
- Safety aand tolerability of nevirapine, stavudine and lamivudine
- Pharmacogenomics of Ugandan subjects

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
Uganda | |
Makerere University, Infectious Diseases Insititute | |
Kampala, Uganda, 22418 |
Principal Investigator: | Concepta Merry, PhD | Trinity College Dublin | |
Study Director: | Keith McAdam | Infectious Diseases Institute, Makerere University |
Publications:
Responsible Party: | Concepta Merry, Infectious Diseases Institute |
ClinicalTrials.gov Identifier: | NCT00455585 History of Changes |
Other Study ID Numbers: |
CPR001 |
First Posted: | April 3, 2007 Key Record Dates |
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 |