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
  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
APV30005 enabled Human Immunodeficiency Virus (HIV)‐infected participants who had received a Fosamprenavir (FPV)‐containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI‐experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.

Reporting Groups
  Description
FPV Population (APV30001) Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
NFV Population (APV30001) FPV +/- RTV + background regimen in participants who had received nelfinavir (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 Once Daily (QD) Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
FPV/RTV Twice Daily (BID) Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
Protease Inhibitor (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
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Participant Flow for 2 periods

Period 1:   Interim Analysis
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV Once Daily (QD) Population (APV30003)     FPV/RTV Twice Daily (BID) Population (APV30003)     Protease Inhibitor (PI)-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Final Analysis Population (APV30005)  
STARTED     119     18     221     54     73     78     104     86     0  
Ongoing     32     12     16     22     0     0     30     1     0  
COMPLETED     43     0     116     11     36     41     30     37     0  
NOT COMPLETED     76     18     105     43     37     37     74     49     0  
Withdrawal by Subject                 8                 0                 12                 0                 5                 5                 9                 3                 0  
Lost to Follow-up                 13                 3                 26                 8                 14                 4                 11                 4                 0  
Clinical Progression                 1                 0                 1                 1                 0                 2                 1                 2                 0  
Insufficient Viral Load Response                 5                 1                 12                 2                 7                 9                 2                 24                 0  
Adverse Event                 0                 0                 13                 4                 6                 3                 4                 5                 0  
Protocol Violation                 0                 0                 2                 0                 1                 0                 0                 1                 0  
Insufficient CD4 Response                 0                 0                 0                 0                 1                 1                 0                 0                 0  
Switched to Commercially Available Drug                 2                 0                 4                 1                 0                 5                 3                 4                 0  
Pregnancy                 4                 1                 4                 2                 0                 1                 1                 1                 0  
Death                 1                 0                 3                 0                 0                 0                 0                 0                 0  
Participant Non-compliant                 0                 1                 2                 1                 1                 3                 6                 2                 0  
Participant Wanted to Become Pregnant                 0                 0                 2                 0                 0                 1                 0                 0                 0  
To Simplify Treatment                 0                 0                 1                 0                 0                 0                 2                 0                 0  
Participant Had Problems with Alcohol                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Participant Moved                 1                 0                 1                 0                 0                 1                 1                 0                 0  
Participant Was Incarcerated                 2                 0                 1                 0                 0                 0                 0                 0                 0  
Resistance to FPV                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Physician Decision                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Principle Investigator Discretion                 2                 0                 1                 1                 0                 0                 0                 0                 0  
Principle Investigator Terminated Study                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Non-adherence                 2                 0                 0                 0                 1                 0                 0                 1                 0  
Site Closing                 1                 0                 0                 0                 0                 1                 2                 0                 0  
Lack of Personnel at Site                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Missed Schedule Date                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Inclusion in Other Protocol                 0                 0                 0                 1                 0                 0                 0                 0                 0  
Participant Stopped                 0                 0                 0                 0                 1                 0                 0                 0                 0  
Physician and Participant Decision                 0                 0                 0                 0                 0                 1                 0                 0                 0  
Participant Stopped HIV Medications                 0                 0                 0                 0                 0                 0                 1                 0                 0  
Study Ended                 0                 0                 0                 0                 0                 0                 1                 0                 0  
Participant Needed Interferon                 0                 0                 0                 0                 0                 0                 0                 1                 0  
Ongoing                 32                 12                 16                 22                 0                 0                 30                 1                 0  

Period 2:   Final Analysis
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV Once Daily (QD) Population (APV30003)     FPV/RTV Twice Daily (BID) Population (APV30003)     Protease Inhibitor (PI)-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Final Analysis Population (APV30005)  
STARTED     0     0     0     0     0     0     0     0     111 [1]
COMPLETED     0     0     0     0     0     0     0     0     90  
NOT COMPLETED     0     0     0     0     0     0     0     0     21  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 5  
Insufficient Viral Load Response                 0                 0                 0                 0                 0                 0                 0                 0                 6  
Adverse Event                 0                 0                 0                 0                 0                 0                 0                 0                 2  
Pregnancy                 0                 0                 0                 0                 0                 0                 0                 0                 4  
Tuberculosis                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Participant Moved to Another Country                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Poor Adherence                 0                 0                 0                 0                 0                 0                 0                 0                 1  
[1] Continued in study; commercial supplies of FPV were unavailable locally at end of Interim Analysis.



  Baseline Characteristics
  Hide Baseline Characteristics

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 ]
  Hide Outcome Measure 17

Measure Type Secondary
Measure Title Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Measure Description Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Time Frame Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168  
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.
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.

Reporting Groups
  Description
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

Measured Values
    FPV/RTV QD Population (APV30003)     FPV/RTV BID Population (APV30003)     PI-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)  
Number of Participants Analyzed  
[units: participants]
  73     78     93     82  
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168  
[units: log 10 copies per milliliter]
Median ( Full Range )
       
Baseline, n=73, 78, 92, 82     3.96  
  ( 3.0 to 5.8 )  
  4.06  
  ( 2.3 to 5.9 )  
  1.7  
  ( 1.7 to 4.9 )  
  1.81  
  ( 1.7 to 6.2 )  
Week 12, n=69, 78, 92, 79     1.7  
  ( 1.7 to 5.3 )  
  1.81  
  ( 1.7 to 5.8 )  
  1.7  
  ( 1.7 to 6.0 )  
  2.03  
  ( 1.7 to 5.9 )  
Week 24, n=73, 75, 93, 79     1.69  
  ( 1.69 to 4.8 )  
  1.69  
  ( 1.69 to 5.6 )  
  1.7  
  ( 1.7 to 5.5 )  
  1.9  
  ( 1.7 to 5.7 )  
Week 48, n=73, 77, 85, 68     1.71  
  ( 1.7 to 4.5 )  
  1.69  
  ( 1.69 to 5.8 )  
  1.7  
  ( 1.7 to 5.3 )  
  1.7  
  ( 1.7 to 5.1 )  
Week 72, n=65, 73, 80, 53     1.72  
  ( 1.7 to 5.5 )  
  1.69  
  ( 1.69 to 5.4 )  
  1.7  
  ( 1.7 to 4.7 )  
  1.7  
  ( 1.7 to 5.3 )  
Week 96, n=60, 62, 75, 51     1.69  
  ( 1.69 to 4.9 )  
  1.69  
  ( 1.69 to 5.2 )  
  1.7  
  ( 1.7 to 5.4 )  
  1.7  
  ( 1.7 to 5.8 )  
Week 132, n=50, 58, 65, 46     1.69  
  ( 1.69 to 4.8 )  
  1.69  
  ( 1.69 to 5.8 )  
  1.7  
  ( 1.7 to 4.0 )  
  1.7  
  ( 1.7 to 5.3 )  
Week 168, n=44, 48, 20, 39     1.69  
  ( 1.69 to 4.8 )  
  1.69  
  ( 1.69 to 4.9 )  
  1.7  
  ( 1.7 to 2.8 )  
  1.7  
  ( 1.7 to 4.5 )  

No statistical analysis provided for Median Plasma HIV-1 RNA at 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
  Hide 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
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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