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

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.