An open-label, non-randomized, single arm study, to investigate the mechanism(s) by which nevirapine increases plasma high density lipoproteins concentration in HIV + subjects treated with Viramune tablets - NILE study

Boehringer Ingelheim Netherlands B.V.0 个研究点目标入组 20 人开始时间: 2005年7月15日最近更新: 2020年7月20日

试验速览

暂无简介。

•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 50 copies/ml documented on at least two occasions within 6 months prior to enrollment
•Documentation of plasma HIV-1-RNA< or equal 50 copies/ml for> 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

•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
•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)

发起方

Boehringer Ingelheim Netherlands B.V.