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: May 4, 2016
Last verified: May 2016
Results First Received: December 2, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Ritonavir
Drug: saquinavir [Invirase]

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted from 12 September 2006 to 09 April 2009 at 3 sites in US and 2 in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 19 participants were screened. A total 9 participants with HIV infection with moderate liver disease (Group 2) and 7 participants with HIV infection with normal liver function (Group 1) were enrolled in the study. Participants in Group 1 were matched with those in Group 2 on the basis of age, gender, weight, and tobacco use.

Reporting Groups
  Description
Normal Liver Function Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Moderate Hepatic Impairment Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.

Participant Flow:   Overall Study
    Normal Liver Function     Moderate Hepatic Impairment  
STARTED     7     9  
COMPLETED     7     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Normal Liver Function Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
Moderate Hepatic Impairment Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
Total Total of all reporting groups

Baseline Measures
    Normal Liver Function     Moderate Hepatic Impairment     Total  
Number of Participants  
[units: participants]
  7     9     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     9     16  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     3     5  
Male     5     6     11  



  Outcome Measures
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1.  Primary:   Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 ]

2.  Primary:   Maximum Observed Plasma Concentration (Cmax) of SQV and RTV   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 ]

3.  Secondary:   Time of Maximum Plasma Concentration (Tmax) of SQV and RTV   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 ]

4.  Secondary:   Terminal Half-life (T1/2) of SQV and RTV   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14 ]

5.  Secondary:   Minimum Observed Plasma Concentration (Cmin) of SQV and RTV   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 ]

6.  Secondary:   Plasma Clearance After Oral Administration (CL/F) of SQV and RTV   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 ]

7.  Secondary:   Volume of Distribution (Vd) of SQV and RTV   [ Time Frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14 ]

8.  Secondary:   Cluster of Differentiation 4 (CD4 ) Count   [ Time Frame: Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35) ]

9.  Secondary:   Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters   [ Time Frame: Up to Day 35 ]

10.  Secondary:   Number Participants With Abnormal Vital Signs   [ Time Frame: Up to Day 35 ]

11.  Secondary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Up to Day 35 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: F. Hoffmann-La Roche AG
Organization: Roche Trial Information Hotline
phone: +41 61 6878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00435929     History of Changes
Other Study ID Numbers: BP17921
Study First Received: February 15, 2007
Results First Received: December 2, 2015
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration