Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-28 @ 8:19 AM
Study NCT ID:
NCT00144261
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2005-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019829', 'term': 'Nevirapine'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change of fractional synthetic rate (FSR) of Apo A-1', 'timeFrame': 'after 6 weeks of treatment'}, {'measure': 'Percentage change of flow mediated dilatation (FMD)', 'timeFrame': 'after 6 and 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Percentage change in the proteins involved in HDL metabolism', 'timeFrame': 'after 6 and 24 weeks of treatment'}, {'measure': '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', 'timeFrame': 'from week 0 to 6, and 24 weeks of treatment'}, {'measure': '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', 'timeFrame': 'from week 0 to 24 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['HIV Infections', 'Metabolism, Lipids']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/19667106', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\n \\[ Designated as safety issue: No \\]\n2. 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.\n\n\\[ Designated as safety issue: No \\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients will be included when they meet the following criteria:\n\n1. 18 years of age or older.\n2. Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.\n3. Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.\n4. Patients with plasma HIV-1-RNA \\<=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.\n5. 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.\n6. Ability and willingness to complete the study.\n\nExclusion Criteria:\n\nPatients will not be included when they meet one or more of the following criteria:\n\n1. Previous exposure to NNRTI drugs.\n2. Documented diabetes mellitus.\n3. Documented hypertension (systolic \\>155 mmHg and/or diastolic \\>95 mmHg).\n4. Fasting hypertriglyceridemia (\\>5.6 mmol/L or 500 mg/dl).\n5. Use of lipid-lowering medication during the 90 days prior to study enrollment.\n6. Chronic active hepatitis B and/or C infection by history.\n7. Anemia (Hb \\<7.0 mmol/l or 11 g/dl hematocrit \\<32%).\n8. 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.\n9. Any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease).\n10. Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.\n11. Pregnancy or lactation.\n12. Active anticoagulation therapy (coumarin derivates, heparin).\n13. History of HIV-2 infection.\n14. Female patients with CD4 counts \\>250 cells/mm3.\n15. Male patients with CD4 counts \\>400 cells/mm3. Others which can not be listed here."}, 'identificationModule': {'nctId': 'NCT00144261', 'briefTitle': 'An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1100.1426'}}, 'armsInterventionsModule': {'interventions': [{'name': 'nevirapine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': '1100.1426.01 Academic Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': '1100.1426.02 Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '1100.1426.44001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}