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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

Primary Purpose

HIV Infections, Metabolism, Lipids

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
nevirapine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients will be included when they meet the following criteria: 18 years of age or older. Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation. Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening. Patients with plasma HIV-1-RNA <=50 copies/mL documented on at least two occasions within 6 months prior to enrollment. 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. Ability and willingness to complete the study. Exclusion Criteria: Patients will not be included when they meet one or more of the following criteria: Previous exposure to NNRTI drugs. Documented diabetes mellitus. Documented hypertension (systolic >155 mmHg and/or diastolic >95 mmHg). Fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl). Use of lipid-lowering medication during the 90 days prior to study enrollment. Chronic active hepatitis B and/or C infection by history. Anemia (Hb <7.0 mmol/l or 11 g/dl hematocrit <32%). 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. Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease). Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator. Pregnancy or lactation. Active anticoagulation therapy (coumarin derivates, heparin). History of HIV-2 infection. Female patients with CD4 counts >250 cells/mm3. Male patients with CD4 counts >400 cells/mm3. Others which can not be listed here.

Sites / Locations

  • 1100.1426.01 Academic Medical Centre
  • 1100.1426.02 Onze Lieve Vrouwe Gasthuis
  • 1100.1426.44001 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Percentage change of fractional synthetic rate (FSR) of Apo A-1
Percentage change of flow mediated dilatation (FMD)

Secondary Outcome Measures

Percentage change in the proteins involved in HDL metabolism
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
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

Full Information

First Posted
September 2, 2005
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00144261
Brief Title
An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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 ] 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 ]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Metabolism, Lipids

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nevirapine
Primary Outcome Measure Information:
Title
Percentage change of fractional synthetic rate (FSR) of Apo A-1
Time Frame
after 6 weeks of treatment
Title
Percentage change of flow mediated dilatation (FMD)
Time Frame
after 6 and 24 weeks of treatment
Secondary Outcome Measure Information:
Title
Percentage change in the proteins involved in HDL metabolism
Time Frame
after 6 and 24 weeks of treatment
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be included when they meet the following criteria: 18 years of age or older. Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation. Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening. Patients with plasma HIV-1-RNA <=50 copies/mL documented on at least two occasions within 6 months prior to enrollment. 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. Ability and willingness to complete the study. Exclusion Criteria: Patients will not be included when they meet one or more of the following criteria: Previous exposure to NNRTI drugs. Documented diabetes mellitus. Documented hypertension (systolic >155 mmHg and/or diastolic >95 mmHg). Fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl). Use of lipid-lowering medication during the 90 days prior to study enrollment. Chronic active hepatitis B and/or C infection by history. Anemia (Hb <7.0 mmol/l or 11 g/dl hematocrit <32%). 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. Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease). Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator. Pregnancy or lactation. Active anticoagulation therapy (coumarin derivates, heparin). History of HIV-2 infection. Female patients with CD4 counts >250 cells/mm3. Male patients with CD4 counts >400 cells/mm3. Others which can not be listed here.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1100.1426.01 Academic Medical Centre
City
Amsterdam
Country
Netherlands
Facility Name
1100.1426.02 Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
1100.1426.44001 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1426_U08-3880.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1426_literature.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/19667106
Description
Related Info

Learn more about this trial

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

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