Status:
COMPLETED
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00435929
Start Date
September 1 2006
End Date
November 1 2009
Last Update
March 29 2018
Active Locations (8)
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1
Chicago, Illinois, United States, 60612
2
Somers Point, New Jersey, United States, 08244
3
Voorhees Township, New Jersey, United States, 08043
4
Philadelphia, Pennsylvania, United States, 19104