Raltegravir/Atazanavir pharmacokinetics and evaluation of lipids - RAPHAE
- Conditions
- chronic HIV infectionMedDRA version: 9.1Level: LLTClassification code 10008919Term: Chronic HIV infection
- Registration Number
- EUCTR2008-001881-10-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
a. Inclusion i. Age > 18 years ii. Documented chronic HIV infection iii. Signed informed consent iv. Effective ongoing treatment (HIV-RNA < 50 copies/ml for longer than 6 months and at least in 3 evaluations). v. Dislipidemic profile (Total cholesterol > 300 mg/dl or TG > 400 mg) vi. No documented resistance to protease inhibitors
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) no
F.1.3.1 Number of subjects for this age range
b. Exclusion i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours ii. Any ongoing grade 4 laboratory abnormality, but for lipid alterations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method