Fosamprenavir in Pts With Hepatic Impairment

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01054586

First received: January 21, 2010

Last updated: May 2, 2013

Last verified: April 2013

History of Changes

Results First Received: January 14, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Infection, Human Immunodeficiency Virus
Interventions:	Drug: Intervention A Standard dose Drug: Intervention B Reduced Dose Drug: Intervention C Drug: Intervention D Drug: Intervention E

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
As this was an observational, retrospective study, no participants were recruited for participation in this study. For more information about this study, see the protocol in ClinicalTrials.gov and/or search for this study (111949) on http://www.gsk-clinicalstudyregister.com/.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
FPV 700 mg BID/RTV 100 mg BID	Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD	FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other	All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
LPV, Standard Dose	Lopinavir (LPV), Standard Dose

Participant Flow: Overall Study

	FPV 700 mg BID/RTV 100 mg BID	FPV 700 mg BID/RTV 100 mg QD	FPV, Other	LPV, Standard Dose
STARTED	43	15	8	101
COMPLETED	43	15	8	101
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
FPV 700 mg BID/RTV 100 mg BID	Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD	FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other	All other dosages of Fosamprenavir
LPV, Standard Dose	Lopinavir (LPV), Standard Dose
Total	Total of all reporting groups

Baseline Measures

	FPV 700 mg BID/RTV 100 mg BID	FPV 700 mg BID/RTV 100 mg QD	FPV, Other	LPV, Standard Dose	Total
Number of Participants [units: participants]	43	15	8	101	167
Age [units: years] Median ( Full Range )	45 ( 36 to 62 )	45 ( 29 to 51 )	44 ( 36 to 53 )	44 ( 25 to 74 )	44 ( 25 to 74 )
Gender [units: participants]
Female	11	3	0	38	52
Male	32	12	8	63	115
Cohort Distribution ^[1] [units: participants]
Cohort - MASTER	36	13	4	72	125
Cohort - HEPAVIH	3	2	2	6	13
Cohort - ICONA	4	0	2	23	29
Number of participants positive for Hepatitis B and/or C at baseline ^[2] [units: participants]
HCV-Ab positive test	37	14	7	82	140
HBs-Ag positive test	9	2	2	21	34
Number of participants who were ART naïve at baseline ^[3] [units: participants]	12	5	2	50	69
Number of participants with acquired immunodeficiency syndrome (AIDS) at baseline ^[4] [units: participants]	9	0	3	24	36
Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline ^[5] [units: participants]
Baseline ALT <= 200 IU/L	40	11	6	83	140
Baseline ALT > 200 IU/L	1	2	1	3	7
Baseline ALT Unknown	2	2	1	15	20

[1]	Source population from three human immunodeficiency virus (HIV)-infected patient cohorts: ICONA (Italian Cohort of Antiretroviral Naïve Patients), treatment naïve participants at initial presentation in Italy; HEPAVIH, HIV-hepatitis coinfected in France; MASTER (Management Standardizzato di Terapia Antiretrovirale), HIV-infected participants who are either treatment experienced or naïve patients in Italy
[2]	Participant characteristics at baseline according to treatment group. Participants were tested for Hepatitis C antibody (HCV-Ab) and Hepatitis B surface antigen (HBs-Ag).
[3]	Participant characteristics at baseline according to treatment group. The number of participants who had not received antiretroviral therapy (ART) was recorded.
[4]	Participant characteristics at baseline according to treatment group. The number of participants with AIDS was recorded.
[5]	Participant characteristics at baseline according to treatment group. The number of participants with the indicated ALT levels was recorded. IU/L = International Units per Liter.

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables [ Time Frame: The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT ]

Show Outcome Measure 1

2. Primary:

Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables [ Time Frame: Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT ]

Show Outcome Measure 2

3. Primary:

Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 3

4. Primary:

Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 4

5. Secondary:

Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 5

6. Secondary:

Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 6

7. Secondary:

Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 7

8. Secondary:

Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 8

9. Secondary:

Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments) [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 9

10. Secondary:

Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 10

11. Secondary:

Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 11

12. Secondary:

Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 12

13. Secondary:

Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events [ Time Frame: Incidence was assessed over time during Year 1 ]

Show Outcome Measure 13

14. Secondary:

Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r [ Time Frame: Assessed over time during Year 1 ]

Show Outcome Measure 14

15. Secondary:

Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen [ Time Frame: Assessed over time during Year 1 ]

Show Outcome Measure 15

16. Secondary:

Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only [ Time Frame: The incidence of these events was assessed over time during Year 1 ]

Show Outcome Measure 16

17. Secondary:

Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures [ Time Frame: Incidence of these events was assessed over time during Year 1 ]

Show Outcome Measure 17

18. Other Pre-specified:

Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline [ Time Frame: Baseline ]

Hide Outcome Measure 18

Measure Type	Other Pre-specified
Measure Title	Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline
Measure Description	Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.
Time Frame	Baseline
Safety Issue	No

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.
HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe

Reporting Groups

	Description
FPV 700 mg BID/RTV 100 mg BID	Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
FPV 700 mg BID/RTV 100 mg QD	FPV 700 mg BID/RTV 100 mg once a day (QD)
FPV, Other	All other dosages of Fosamprenavir
LPV, Standard Dose	Lopinavir (LPV), Standard Dose

Measured Values

	FPV 700 mg BID/RTV 100 mg BID	FPV 700 mg BID/RTV 100 mg QD	FPV, Other	LPV, Standard Dose
Number of Participants Analyzed [units: participants]	43	15	8	101
Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline [units: years] Median ( Full Range )
Length of follow-up	0.36 ( 0.07 to 1.07 )	0.36 ( 0.04 to 1.02 )	0.95 ( 0.6 to 1.50 )	0.34 ( 0.12 to 1.46 )
Tiime on ART	1.7 ( 0 to 12 )	1.0 ( 0 to 11 )	3.21 ( 0 to 10 )	0.08 ( 0 to 12.8 )

No statistical analysis provided for Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline

19. Other Pre-specified:

Cluster of Differentiation (CD4) Count at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 19

20. Other Pre-specified:

Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 20

21. Other Pre-specified:

Median FIB (a Model of End-stage Liver Disease) Score at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 21

22. Other Pre-specified:

Median Model of End-stage Liver Disease (MELD) Score at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 22

23. Other Pre-specified:

Median ALT and AST Scores at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 23

24. Other Pre-specified:

Median Blood Platelet Count at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 24

25. Other Pre-specified:

Median Bilirubin Level at Baseline [ Time Frame: Baseline ]

Show Outcome Measure 25

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01054586 History of Changes
Other Study ID Numbers:	111949, WEUKSTV2430, EPI40537
Study First Received:	January 21, 2010
Results First Received:	January 14, 2011
Last Updated:	May 2, 2013
Health Authority:	United Kingdon: No Health Authority

To Top