An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma HDL
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An open label, single arm, non-randomized study in 20 HIV-1 infected patients aged >=18 years who are virologically stable on Trizivir therapy for at least 6 months. Patients will have Viramune introduced into their regimens and over the subsequent 6 months will have their blood lipid levels, including lipoproteins and enzymes involved in lipid metabolism, closely monitored. Two primary endpoints are sought: the synthetic rate of lipoprotein A1 (a precursor to HDL cholesterol) and the flow mediated dilatation index of each patient. This latter value has been shown to be predictive of cardiovascular events.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Metabolism, Lipids |
Drug: nevirapine |
Phase 4 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Prevention |
Official Title: | An Open-label, Non-randomized, Single-arm Study to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma High Density Lipoprotein Concentrations in HIV+ Subjects Treated With Viramune Tablets |
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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Netherlands | |
1100.1426.02 Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands | |
1100.1426.01 Academic Medical Centre | |
Amsterdam, Netherlands | |
United Kingdom | |
1100.1426.44001 Boehringer Ingelheim Investigational Site | |
London, United Kingdom |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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Additional Information:
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No publications provided
Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00144261 History of Changes |
Other Study ID Numbers: | 1100.1426 |
Study First Received: | September 2, 2005 |
Last Updated: | May 18, 2012 |
Health Authority: | Great Britain: Medicines and Health Care Prods. Reg. Agency Netherlands: n/a (Dutch Authority approval not required) |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 03, 2013