Roche trials database

Trial information

A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

Status:

Completed

Protocol number:

BP17921

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Effect of moderate liver impairment on the pharmacokinetics of saquinavir after administration of saquinavir/ritonavir 1000/100mg BID in HIV patients

Brief summary:

This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 16.

Study phase:

I

Study type:

Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study

Conditions:

• HIV Infections

Intervention type:

Drug

Intervention name:

saquinavir [Invirase]

Primary outcome:

1. AUC, Cmax of SQV and RTV Time frame: Day 14

Key secondary outcomes:

1. Tmax, T1/2, CL/F, Cmin, Vd Time frame: Day 14
2. HIV-1 RNA viral load, CD4, HCV-RNA viral load, HBV-DNA viral load. Time frame: Days 8 and 14
3. AEs, laboratory parameters. Time frame: Throughout study

Inclusion criteria:

• adult patients, 18-65 years of age;
• HIV infection;
• normal liver function, or moderate liver disease (Child-Pugh grade B);
• antiretroviral therapy naive and eligible to take antiretroviral treatment as per treatment guidelines, or treatment experienced for at least 4 weeks prior to first dosing.

Exclusion criteria:

• severe ascites at screening, or Child-Pugh grade C;
• acute infection or current malignancy requiring treatment;
• taking any inhibitor of CYP3A4 (with the exception of anti-HIV drugs) within 14 days prior to first dosing;
• taking any inducer of CYP3A4 (with the exception of anti-HIV drugs) within 4 weeks prior to pharmacokinetic evaluation (day 14 or 28);
• evidence of resistance to saquinavir.

Gender:

Males or Females

Age limits:

Min: 18 years Max: 65 years

Accepts healthy volunteers:

No

Anticipated start date:

September, 2006

Trial registration date:

20.12.2006

Date last updated:

24.03.2010

This trial was conducted at the following locations:

Canada

• OTTAWA, ON
• TORONTO, ON

U.S.A.

• CHICAGO, IL
• SOMERS POINT, NJ
• VOORHEES, NJ
• PHILADELPHIA, PA
• SAN JUAN, PR
• DALLAS, TX

Link to trial result