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

NCT00144261 | Completed Phase 4

• 1 other identifier: 1100.1426
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

Brief Summary

1. 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.
2. 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.

Conditions

HIV Infections; Metabolism, Lipids

Outcome Measures

Primary Outcomes (2)

• Percentage change of fractional synthetic rate (FSR) of Apo A-1

  after 6 weeks of treatment

• Percentage change of flow mediated dilatation (FMD)

  after 6 and 24 weeks of treatment

Secondary Outcomes (3)

• Percentage change in the proteins involved in HDL metabolism

  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

  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

  from week 0 to 24 weeks of treatment

Interventions

nevirapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included when they meet the following criteria:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (3)

1100.1426.01 Academic Medical Centre

Amsterdam, Netherlands

Location

1100.1426.02 Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

1100.1426.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: November 1, 2003
• Primary Completion: December 1, 2006
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); GB (1)