Pharmacokinetics of atazanavir at the dose of 300mg or 400mg in subjects with HIV-1 infection and non-decompensated hepatic cirrhosis (Child-Pugh A o B, Metavir F4), crossover study. - EPAZANAVIR-1
- Conditions
- HIV-1 InfectionMedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection
- Registration Number
- EUCTR2007-005330-37-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
> 18 years-old, able to give an informed consent.
Need to be treated with atazanavir.
Hepatic cirrhosis of any cause, Child-Pugh A o B, Metavir F4.
HIV-RNA < 100,000 copies/mL.
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
NNRTI treatment at the moment of receiving atazanavir or need to include NNRTI or Tenofovir in the ARV regimen.
Active HIV-disease or possibility of a rapid deterioration.
Therapy with Interferons.
Hyperbilirubinemia > 3,5, ascitis or oedema.
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