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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00435929
First received: February 15, 2007
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This 2 arm study will assess the effect of moderate liver impairment on the phar macokinetics of saquinavir and ritonavir at steady state following administratio n of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritona vir will be administered concomitantly with 2 to 3 active nucleoside reverse tra nscriptase inhibitors. The study will compare a group of HIV patients without kn own 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.


Condition Intervention Phase
HIV Infections
Drug: Ritonavir
Drug: saquinavir [Invirase]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Moderate Liver Impairment on the Pharmacokinetics of Saquinavir After Administration of Saquinavir/Ritonavir 1000/100mg BID in HIV Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AUC, Cmax of SQV and RTV [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax, T1/2, CL/F, Cmin, Vd [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • HIV-1 RNA viral load, CD4, HCV-RNA viral load, HBV-DNA viral load. [ Time Frame: Days 8 and 14 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ritonavir
100mg po bid
Drug: saquinavir [Invirase]
1000mg po bid
Experimental: 2 Drug: Ritonavir
100mg po bid
Drug: saquinavir [Invirase]
1000mg po bid

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435929

Locations
United States, Illinois
Chicago, Illinois, United States, 60612
United States, New Jersey
Somers Point, New Jersey, United States, 08244
Voorhees, New Jersey, United States, 08043
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Dallas, Texas, United States, 75204
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2C4
Puerto Rico
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00435929     History of Changes
Other Study ID Numbers: BP17921
Study First Received: February 15, 2007
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ritonavir
Saquinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014