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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144261 |
An open label, single arm, non-randomized study in 20 HIV-1 infected patients aged >=18 years who are virologically stable on Trizivir therapy for at least 6 months. Patients will have Viramune introduced into their regimens and over the subsequent 6 months will have their blood lipid levels, including lipoproteins and enzymes involved in lipid metabolism, closely monitored. Two primary endpoints are sought: the synthetic rate of lipoprotein A1 (a precursor to HDL cholesterol) and the flow mediated dilatation index of each patient. This latter value has been shown to be predictive of cardiovascular events.
Condition | Intervention | Phase |
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HIV Infections Metabolism, Lipids |
Drug: nevirapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label, Non-Randomized, Single-Arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma High Density Lipoprotein Concentrations in HIV+ Subjects Treated With Viramune Tablets |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Patients will be included when they meet the following criteria:
Exclusion Criteria:
Patients will not be included when they meet one or more of the following criteria:
Netherlands | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands | |
Academic Medical Centre | |
Amsterdam, Netherlands | |
United Kingdom | |
Boehringer Ingelheim Investigational Site | |
London, United Kingdom |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
Study ID Numbers: | 1100.1426 |
Study First Received: | September 2, 2005 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00144261 |
Health Authority: | Netherland: n/a (Dutch Authority approval not required); Great Britain: Medicines and Health Care Prods. Reg. Agency |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |