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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.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00144261
First received: September 2, 2005
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Primary Purpose: Prevention
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

Resource links provided by NLM:

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 14
Study Start Date: November 2003
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
1100.1426.02 Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
1100.1426.01 Academic Medical Centre
Amsterdam, Netherlands
United Kingdom
1100.1426.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144261     History of Changes
Other Study ID Numbers: 1100.1426
Study First Received: September 2, 2005
Last Updated: May 18, 2012
Health Authority: Great Britain: Medicines and Health Care Prods. Reg. Agency
Netherlands: n/a (Dutch Authority approval not required)

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
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

ClinicalTrials.gov processed this record on March 03, 2013