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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005330-37-IT
Enrollment
Unknown
Registered
2007-10-16
Start date
2008-02-20
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection

Interventions

Trade Name: REYATAZ Pharmaceutical Form: Capsule, hard INN or Proposed INN: Atazanavir CAS Number: 198904-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Sponsors

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the feasibility of atazanavir 300mg in subjects with HIV-1 infection and non-decompensated hepatic cirrhosis.;Secondary Objective: To evaluate the efficacy of a combined approach (US, FibroScan, breath test)in order to discover subjects with a significant reduction in the hepatic metabolic function.;Primary end point(s): Atazanavir Ctrough always > 150ng/mL of plasma.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026