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

Phase 1

Active, not recruiting

• Conditions: Treatment of HIV infection

• Registration Number: EUCTR2005-001372-12-GB
• Lead Sponsor: Boehringer Ingelheim Netherlands B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-15
• Study Completion: 2006-12-22
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 20

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 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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified