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

NCT ID: NCT00435929

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-11-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Ritonavir

Intervention Type: DRUG

100mg po bid

saquinavir [Invirase]

Intervention Type: DRUG

1000mg po bid

2

Group Type: EXPERIMENTAL

Ritonavir

Intervention Type: DRUG

100mg po bid

saquinavir [Invirase]

Intervention Type: DRUG

1000mg po bid

Interventions

Ritonavir

100mg po bid

Intervention Type: DRUG

saquinavir [Invirase]

1000mg po bid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Chicago, Illinois, United States

Somers Point, New Jersey, United States

Voorhees Township, New Jersey, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

San Juan, , Puerto Rico

Countries

United States; Canada; Puerto Rico

Other Identifiers

BP17921

Identifier Type: -

Identifier Source: org_study_id