An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL in HIV+ Subjects
- Conditions
- HIV InfectionsMetabolism, Lipids
- Registration Number
- NCT00144261
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
\[ Designated as safety issue: No \]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change of flow mediated dilatation (FMD) after 6 and 24 weeks of treatment Percentage change of fractional synthetic rate (FSR) of Apo A-1 after 6 weeks of treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
1100.1426.02 Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
1100.1426.01 Academic Medical Centre
🇳🇱Amsterdam, Netherlands
1100.1426.44001 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom