A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00296504
First received: February 24, 2006
Last updated: April 11, 2013
Last verified: June 2012
Results First Received: September 30, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: fosamprenavir (GW433908)
Drug: ritonavir

  Participant Flow


  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.
No text entered.

Reporting Groups
  Description
FPV Population (APV30001) FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
NFV Population (APV30001) FPV +/- RTV + background regimen in participants who had received NFV in APV30001
FPV Population (APV30002) FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
NFV Population (APV30002) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
FPV/RTV QD Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
FPV/RTV BID Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
PI-Naïve Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
PI-Experienced Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Total Total of all reporting groups

Baseline Measures
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV QD Population (APV30003)     FPV/RTV BID Population (APV30003)     PI-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Total  
Number of Participants  
[units: participants]
  119     18     221     54     73     78     104     86     753  
Age, Customized  
[units: years]
Mean ( Full Range )
  36.3  
  ( 17 to 70 )  
  35.8  
  ( 22 to 54 )  
  37.7  
  ( 19 to 69 )  
  36.2  
  ( 26 to 63 )  
  41.9  
  ( 27 to 58 )  
  42.3  
  ( 24 to 71 )  
  39.3  
  ( 21 to 75 )  
  40.2  
  ( 19 to 60 )  
  38.7  
  ( 17 to 75 )  
Gender  
[units: Participants]
                 
Female     36     9     63     23     9     12     24     22     198  
Male     83     9     158     31     64     66     80     64     555  
Race/Ethnicity, Customized  
[units: participants]
                 
White     34     1     109     14     59     56     44     77     394  
Black     35     6     86     34     10     14     34     7     226  
Asian     1     0     4     0     1     1     1     0     8  
American Hispanic     49     11     16     2     3     7     23     2     113  
Other: Race Not Specified     0     0     6     4     0     0     2     0     12  
Number of Participants with the Indicated CDC Classification of HIV Infection [1]
[units: participants]
                 
Asymptomatic or lymphadenopathy     81     16     124     13     26     30     76     29     395  
Symptomatic, not AIDS     17     1     48     23     21     24     23     18     175  
Acquired Immune Deficiency Syndrome (AIDS)     21     1     49     18     26     24     5     39     183  
[1] The Centers for Disease Control and Prevention (CDC) 1993 classification system for HIV infection was based on three clinical categories (A, B, and C). Category A comprised asymptomatic acute or primary HIV infection or persistent generalized lymphadenopathy (lymphnode disease). Category B comprised symptomatic conditions not included in clinical categories A or C but attributed to a cell-mediated immunity defect or for which the clinical course or management was complicated by HIV infection. Category C comprised AIDS-defining conditions.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Event (AE): Interim Analysis   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]

2.  Primary:   Number of Participants With Any Adverse Event (AE): Final Analysis   [ Time Frame: Post January 2006; for up to 241 weeks ]

3.  Primary:   Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216   [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216 ]

4.  Primary:   Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432   [ Time Frame: Weeks 120, 180, 204, 216, and 432 ]

5.  Primary:   Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216   [ Time Frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 ]

6.  Primary:   Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168   [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168 ]

7.  Primary:   Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432   [ Time Frame: Weeks 120, 180, 204, 216, and 432 ]

8.  Primary:   Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216   [ Time Frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 ]

9.  Primary:   Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168   [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168 ]

10.  Primary:   Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432   [ Time Frame: Weeks 120, 180, 204, 216, and 432 ]

11.  Secondary:   Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)   [ Time Frame: Baseline and Weeks 48, 120, 180, and 216 ]

12.  Secondary:   Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)   [ Time Frame: Baseline and Weeks 12, 24, 48, 60, 96, and 132 ]

13.  Secondary:   Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)   [ Time Frame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 ]

14.  Secondary:   Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis   [ Time Frame: Baseline and Weeks 48, 120, 168, 180, 204, and 216 ]

15.  Secondary:   Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis   [ Time Frame: Baseline and Weeks 24, 48, 96, 132, and 168 ]

16.  Secondary:   Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216   [ Time Frame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 ]

17.  Secondary:   Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168   [ Time Frame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 ]

18.  Secondary:   Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432   [ Time Frame: Weeks 180, 240, 300, 360, 420, and 432 ]

19.  Secondary:   Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]

20.  Secondary:   Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]

21.  Secondary:   Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]


  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: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00296504     History of Changes
Other Study ID Numbers: APV30005
Study First Received: February 24, 2006
Results First Received: September 30, 2011
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration