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Sponsors and Collaborators: |
Makerere University Department of Foreign Affairs, Ireland |
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Information provided by: | Makerere University |
ClinicalTrials.gov Identifier: | NCT00455585 |
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 |
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HIV Infections |
Drug: nevirapine, stavudine, lamivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study |
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. |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Infectious Diseases Institute ( Concepta Merry ) |
Study ID Numbers: | CPR001 |
Study First Received: | April 2, 2007 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00455585 History of Changes |
Health Authority: | Uganda: National Council for Science and Technology |
Pharmacokinetics Antiretrovirals Uganda HIV Treatment Experienced |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Anti-HIV Agents Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Virus Diseases Nevirapine HIV Seropositivity Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |