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: August 26, 2014
Last verified: August 2014

February 15, 2007
August 26, 2014
September 2006
November 2009   (final data collection date for primary outcome measure)
AUC, Cmax of SQV and RTV [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
AUC, Cmax of saquinavir and ritonavir.
Complete list of historical versions of study NCT00435929 on ClinicalTrials.gov Archive Site
  • 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 ]
Pharmacokinetics: Tmax, T1/2, CL/F, Cmin, Vd. Pharmacodynamics: HIV-1 RNA viral load, CD4, HCV-RNA viral load, HBV-DNA viral load. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Effect of Moderate Liver Impairment on the Pharmacokinetics of Saquinavir After Administration of Saquinavir/Ritonavir 1000/100mg BID in HIV Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Ritonavir
    100mg po bid
  • Drug: saquinavir [Invirase]
    1000mg po bid
  • Experimental: 1
    Interventions:
    • Drug: Ritonavir
    • Drug: saquinavir [Invirase]
  • Experimental: 2
    Interventions:
    • Drug: Ritonavir
    • Drug: saquinavir [Invirase]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00435929
BP17921
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP