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An Open-Label, Non-Randomized, Single-Arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144261
  Purpose

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
HIV Infections
Metabolism, Lipids
Drug: nevirapine
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Nevirapine
U.S. FDA Resources
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment: 15
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

Patients will be included when they meet the following criteria:

  1. 18 years of age or older.
  2. Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
  3. Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.
  4. Patients with plasma HIV-1-RNA <=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.
  5. Documentation of plasma HIV-1 RNA of <=50 copies/mL for >=6 months while on Trizivir without other antiretroviral agent. Documentation will include dates and results of all viral load testing from the previous six months.
  6. Ability and willingness to complete the study.

Exclusion Criteria:

Patients will not be included when they meet one or more of the following criteria:

  1. Previous exposure to NNRTI drugs.
  2. Documented diabetes mellitus.
  3. Documented hypertension (systolic >155 mmHg and/or diastolic >95 mmHg).
  4. Fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl).
  5. Use of lipid-lowering medication during the 90 days prior to study enrollment.
  6. Chronic active hepatitis B and/or C infection by history.
  7. Anemia (Hb <7.0 mmol/l or 11 g/dl hematocrit <32%).
  8. Active opportunistic infection or neoplasm within 3 months prior to screening visit with the exception of cutaneous Kaposi's sarcoma without evidence of progressive disease.
  9. Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease).
  10. Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.
  11. Pregnancy or lactation.
  12. Active anticoagulation therapy (coumarin derivates, heparin).
  13. History of HIV-2 infection.
  14. Female patients with CD4 counts >250 cells/mm3.
  15. Male patients with CD4 counts >400 cells/mm3. Others which can not be listed here.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144261

Locations
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Academic Medical Centre
Amsterdam, Netherlands
United Kingdom
Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Related Info  This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:
Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009