Treatment of HIV infection
Conditions
Interventions
Trade Name: Viramune 200 mg tablets
Product Name: Viramune 200 mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Nevirapine anhydrous
Current Sponsor code: BIRG-587
Concentration unit: mg/g
Sponsors
Boehringer Ingelheim Netherlands B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years of age or older Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening Patients with HIV-1-RNA or equal 6 months while on Trizivir without other ARV. Ability and willingness to complete the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous exposure to NNRTI drugs documented diabetes mellitus Hypertension fasting hypertriglyceridemia (>5.6 mmol/L or 500 mg/dl) use of lipid-lowering medication during the 90 days prior study enrollment chronic active hepatitis B and/or C Anemia active opportunistic infection or neoplasm within 3 months prior to screening Any history of CV disease Hepatic, renal or thyroid abnormalities Pregnancy or lactation Active anticoagulation therapy History of HIV-2 infection Active alcohol/drug abuse ALT/AST > 2.5 x ULN Total Bilirubin > 2 x ULN Use of anabolic steroids during the 90 days prior to study enrollment Patients on any therapy for which a stable regimen has not been achieved for at least 28 days prior to visit 2 Female patients with CD4 counts >250 cells/mm3 Male patients with CD 4 counts >400 cells/mm3 Patients taking and unable to discontinue any of the restricted drugs: - Any investigational agent - All lipid regulating agents (e.g. high dose niacin, fibrates, bile acid sequestering resins, HMG-CoA reductase inhibitors, psyllium derivatives or fish oil) - Azole antifungal agents (IV/oral) - Macrolides - Rifampicin, rifabutin - St. Johns Wort - Antihypertensive medication with known effects on the vascular endothelium (e.g. calcium channel blockers, ACE inhibitors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the mechanism(s) by which Nevirapine increases plasma HDL concentration. To evaluate the effect of increased HDL on endothelial function as a surrogate endpoint for cardiovascular disease.;Secondary Objective: The percentage change of fractional synthethic rate (FSR) of APO A-1 from week 0 (baseline) to 24 weeks of treatment with NVP-based antiretroviral therapy. The percentage change in plasma levels of lipoproteins in the fasting lipid panel from week 0 (baseline) to 6 weeks and at 24 weeks of treatment with NVP-based antiretroviral therapy. The percent change in activity (and/or mass) of the constituents of the lipid enzymes panel at 6 and 24 weeks of NVP-based antiretroviral therapy.;Primary end point(s): The percentage change of fractional synthetic rate (FSR) of apo A-I from week 0 (baseline) to 6 weeks of treatment with NVP-based antiretroviral therapy. The percentage change of flow mediated dilatation (FMD) from week 0 (baseline) to 6 and 24 weeks of treatment with NVP-based antiretroviral therapy. | — |
Countries
United Kingdom
Outcome results
None listed