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An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144261
First received: September 2, 2005
Last updated: November 4, 2013
Last verified: November 2013
  Purpose
  1. In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP containing treatment were evaluated. In addition, the activity of the key enzymes related to HDL metabolism were assessed.

    [ Designated as safety issue: No ]

  2. In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate marker for cardiovascular disease in patients.

[ Designated as safety issue: No ]


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 Lipoproteins Concentration in HIV+ Subjects Treated With VIRAMUNE® Tablets

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage change of fractional synthetic rate (FSR) of Apo A-1 [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage change of flow mediated dilatation (FMD) [ Time Frame: after 6 and 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change in the proteins involved in HDL metabolism [ Time Frame: after 6 and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The percentage change in plasma levels of lipoproteins in the fasting lipid panel (TC, LDL, HDL, TG) from Week 0 (baseline) to 6 and 24 weeks of treatment with NVP-based antiretroviral therapy [ Time Frame: from week 0 to 6, and 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The percentage change in activity (and/or mass) of the constituents of the lipid enzymes panel from Week 0 to 24 weeks of NVP-based antiretroviral therapy [ Time Frame: from week 0 to 24 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 15
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144261

Locations
Netherlands
1100.1426.01 Academic Medical Centre
Amsterdam, Netherlands
1100.1426.02 Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
United Kingdom
1100.1426.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
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: November 4, 2013
Health Authority: Great Britain: Medicines and Health Care Prods. Reg. Agency
Netherlands: n/a (Dutch Authority approval not required)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014