- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144261
An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects
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
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 ]
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Amsterdam, Netherlands
- 1100.1426.01 Academic Medical Centre
-
Amsterdam, Netherlands
- 1100.1426.02 Onze Lieve Vrouwe Gasthuis
-
-
-
-
-
London, United Kingdom
- 1100.1426.44001 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage change of fractional synthetic rate (FSR) of Apo A-1
Time Frame: after 6 weeks of treatment
|
after 6 weeks of treatment
|
Percentage change of flow mediated dilatation (FMD)
Time Frame: after 6 and 24 weeks of treatment
|
after 6 and 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage change in the proteins involved in HDL metabolism
Time Frame: after 6 and 24 weeks of treatment
|
after 6 and 24 weeks of treatment
|
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
|
from week 0 to 6, and 24 weeks of treatment
|
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
|
from week 0 to 24 weeks of treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Nevirapine
Other Study ID Numbers
- 1100.1426
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on nevirapine
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Botswana, Germany, South Africa
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, France, Germany, United Kingdom
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Argentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Switzerland, United Kingdom
-
Boehringer IngelheimCompleted
-
Peking Union Medical CollegeMinistry of Science and Technology of the People´s Republic of ChinaCompleted
-
Boehringer IngelheimCompleted
-
Makerere UniversityUniversity of LiverpoolCompletedHIV Infections | TuberculosisUganda
-
Boehringer IngelheimCompletedHIV InfectionsArgentina, Germany, Italy, Mexico, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom
-
Elim Pediatric Pharmaceuticals Inc.Unknown