Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 
Overall Participants Analyzed 
[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
  Hide 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) ]

Measure Type Primary
Measure Title Number of Participants With Any Adverse Event (AE): Interim Analysis
Measure Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Time Frame Baseline (Day 1) up to 31 January 2006 (up to Week 264)  
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 at least one dose of FPV or FPV/RTV in Study APV30005.

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

Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 119   18   221   54   73   78   104   86 
Number of Participants With Any Adverse Event (AE): Interim Analysis 
[Units: Participants]
 117   16   215   52   72   75   95   68 

No statistical analysis provided for Number of Participants With Any Adverse Event (AE): Interim Analysis



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

Measure Type Primary
Measure Title Number of Participants With Any Adverse Event (AE): Final Analysis
Measure Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Time Frame Post January 2006; for up to 241 weeks  
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 who remained in the study after January 31, 2006.

Reporting Groups
  Description
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Measured Values
   Final Analysis Population (APV30005) 
Participants Analyzed 
[Units: Participants]
 111 
Number of Participants With Any Adverse Event (AE): Final Analysis 
[Units: Participants]
 95 

No statistical analysis provided for Number of Participants With Any Adverse Event (AE): Final Analysis



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 ]

Measure Type Primary
Measure Title Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Measure Description Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time Frame Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216  
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 at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.

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

Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 92   14   159   38   61   65   77   59 
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 
[Units: Milligrams per deciliter (mg/dl)]
Median (Inter-Quartile Range)
               
Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59   10 
 (-34 to 42) 
 -41 
 (-63 to -20) 
 51 
 (14 to 118) 
 20 
 (-19 to 57) 
 9 
 (-25 to 44) 
 14 
 (-69 to 66) 
 5 
 (-27 to 58) 
 -54 
 (-96 to -12) 
Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44   9 
 (-26 to 43) 
 -48 
 (-101 to 8) 
 47 
 (10 to 101) 
 15 
 (-22 to 48) 
 16 
 (-51 to 40) 
 34 
 (-21 to 118) 
 -5 
 (-35 to 42) 
 7 
 (-3 to 41) 
Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40   15 
 (-24 to 59) 
 -33 
 (-77 to 0) 
 43 
 (2 to 121) 
 -4 
 (-24 to 69) 
 13 
 (-27 to 49) 
 22 
 (-39 to 96) 
 -4 
 (-50 to 50) 
 -73 
 (-283 to 2) 
Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40   2 
 (-27 to 46) 
 -2 
 (-66 to 6) 
 47 
 (-0 to 101) 
 18 
 (-21 to 58) 
 14 
 (-63 to 65) 
 18 
 (-61 to 63) 
 6 
 (-48 to 32) 
 -129 
 (-343 to 75) 
Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33   3 
 (-27 to 66) 
 -12 
 (-58 to 25) 
 27 
 (-19 to 86) 
 4 
 (-16 to 49) 
 29 
 (-55 to 59) 
 42 
 (-25 to 177) 
 5 
 (-32 to 27) 
 -167 
 (-238 to -10) 
Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40   8 
 (-38 to 43) 
 -41 
 (-89 to 7) 
 37 
 (4 to 87) 
 18 
 (-16 to 81) 
 13 
 (-27 to 63) 
 8 
 (-95 to 112) 
 -2 
 (-38 to 20) 
 -170 
 (-267 to -56) 
Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40   2 
 (-26 to 44) 
 -36 
 (-88 to -14) 
 43 
 (8 to 87) 
 12 
 (-18 to 54) 
 4 
 (-45 to 28) 
 49 
 (-26 to 161) 
 12 
 (-4 to 33) 
 NA [1] 
Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40   7 
 (-35 to 49) 
 NA [1]   39 
 (4 to 97) 
 98 
 (34 to 163) 
 -7 
 (-165 to 57) 
 66 
 (-33 to 160) 
 NA [1]   NA [1] 
Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59   52 
 (23 to 70) 
 3 
 (-32 to 13) 
 53 
 (26 to 77) 
 10 
 (-6 to 26) 
 14 
 (-9 to 34) 
 13 
 (-12 to 33) 
 8 
 (-13 to 22) 
 22 
 (-14 to 44) 
Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44   39 
 (19 to 58) 
 -3 
 (-16 to 25) 
 46 
 (21 to 68) 
 8 
 (-14 to 23) 
 12 
 (-15 to 26) 
 10 
 (-13 to 38) 
 13 
 (-9 to 32) 
 19 
 (1 to 57) 
Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40   42 
 (22 to 64) 
 -9 
 (-17 to 9) 
 50 
 (23 to 73) 
 9 
 (-15 to 23) 
 11 
 (-16 to 25) 
 22 
 (-8 to 31) 
 13 
 (-10 to 30) 
 32 
 (12 to 44) 
Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40   43 
 (22 to 72) 
 14 
 (-23 to 32) 
 47 
 (18 to 82) 
 13 
 (-10 to 38) 
 14 
 (-13 to 30) 
 -4 
 (-24 to 30) 
 2 
 (-12 to 27) 
 12 
 (-38 to 41) 
Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33   56 
 (28 to 78) 
 6 
 (-18 to 38) 
 47 
 (18 to 76) 
 21 
 (-4 to 60) 
 18 
 (-15 to 34) 
 9 
 (-22 to 31) 
 6 
 (-1 to 23) 
 28 
 (19 to 52) 
Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40   54 
 (22 to 73) 
 -4 
 (-16 to 28) 
 53 
 (24 to 78) 
 19 
 (-4 to 40) 
 3 
 (-8 to 34) 
 9 
 (-19 to 27) 
 5 
 (-1 to 17) 
 43 
 (1 to 61) 
Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40   52 
 (18 to 76) 
 5 
 (-32 to 22) 
 53 
 (22 to 80) 
 22 
 (-18 to 61) 
 -3 
 (-38 to 18) 
 11 
 (-9 to 36) 
 -5 
 (-12 to 14) 
 NA [1] 
Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40   52 
 (25 to 79) 
 NA [1]   47 
 (24 to 70) 
 30 
 (24 to 35) 
 -65 
 (-82 to -48) 
 28 
 (-8 to 34) 
 NA [1]   NA [1] 
HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59,   10 
 (4 to 18) 
 -0.2 
 (-5 to 5) 
 8 
 (2 to 15) 
 3 
 (-5 to 8) 
 6 
 (-1 to 10) 
 2 
 (-4 to 11) 
 3 
 (-3 to 8) 
 8 
 (5 to 13) 
HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44   12 
 (4 to 18) 
 8 
 (1 to 16) 
 12 
 (4 to 19) 
 4 
 (-2 to 10) 
 6 
 (-1 to 12) 
 2 
 (-6 to 10) 
 4 
 (-3 to 8) 
 5 
 (4 to 13) 
HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40   12 
 (6 to 17) 
 5 
 (1 to 11) 
 12 
 (3 to 20) 
 7 
 (0 to 15) 
 8 
 (1 to 13) 
 4 
 (-2 to 9) 
 5 
 (-6 to 11) 
 10 
 (9 to 20) 
HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40   13 
 (4 to 21) 
 6 
 (-1 to 13) 
 12 
 (7 to 20) 
 9 
 (3 to 17) 
 6 
 (3 to 15) 
 5 
 (-2 to 12) 
 3 
 (-6 to 11) 
 16 
 (12 to 22) 
HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0   17 
 (9 to 24) 
 13 
 (3 to 21) 
 17 
 (6 to 24) 
 12 
 (3 to 17) 
 8 
 (-1 to 15) 
 2 
 (-5 to 8) 
 10 
 (3 to 14) 
 5 
 (4 to 24) 
HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40   17 
 (9 to 24) 
 4 
 (1 to 16) 
 15 
 (7 to 25) 
 10 
 (3 to 17) 
 7 
 (1 to 12) 
 4 
 (-4 to 9) 
 12 [2]   18 
 (15 to 26) 
HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40   16 
 (8 to 26) 
 10 
 (-0.2 to 16) 
 17 
 (10 to 26) 
 15 
 (2 to 22) 
 6 
 (-0.19 to 15) 
 2 
 (-7 to 12) 
 3 [2]   NA [1] 
HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40   16 
 (9 to 26) 
 NA [1]   17 
 (7 to 25) 
 4 
 (3 to 6) 
 3 
 (-5 to 4) 
 6 
 (-3 to 12) 
 NA [1]   NA [1] 
LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48   32 
 (20 to 53) 
 10 
 (-11 to 16) 
 30 
 (10 to 53) 
 0 
 (-8 to 19) 
 2 
 (-24 to 21) 
 -1 
 (-15 to 24) 
 3 
 (-13 to 21) 
 17 
 (10 to 29) 
LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37   25 
 (9 to 40) 
 -2 
 (-10 to 12) 
 21 
 (4 to 45) 
 1 
 (-20 to 17) 
 3 
 (-20 to 15) 
 0 
 (-18 to 27) 
 7 
 (-12 to 25) 
 15 
 (13 to 45) 
LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40   27 
 (10 to 44) 
 -4 
 (-11 to 8) 
 21 
 (3 to 41) 
 -2 
 (-21 to 11) 
 -6 
 (-20 to 8) 
 12 
 (-19 to 25) 
 3 
 (-9 to 22) 
 38 
 (22 to 61) 
LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34   25 
 (10 to 42) 
 11 
 (-20 to 18) 
 24 
 (-3 to 43) 
 4 
 (-25 to 19) 
 -4 
 (-27 to 20) 
 -2 
 (-20 to 17) 
 0 
 (-22 to 20) 
 14 
 (14 to 15) 
LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0   37 
 (13 to 54) 
 -5 
 (-17 to 20) 
 18 
 (0.3 to 43) 
 5 
 (-17 to 23) 
 -3 
 (-25 to 11) 
 -6 
 (-27 to 22) 
 -1 
 (-8 to 2) 
 48 
 (24 to 72) 
LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40   27 
 (13 to 56) 
 1 
 (-8 to 18) 
 23 
 (4 to 49) 
 2 
 (-18 to 14) 
 -2 
 (-16 to 17) 
 4 
 (-20 to 18) 
 -7 [2]   54 
 (48 to 60) 
LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40   35 
 (8 to 51) 
 5 
 (-24 to 19) 
 22 
 (2 to 46) 
 13 
 (-18 to 40) 
 -14 
 (-32 to 12) 
 1 
 (-26 to 25) 
 -45 [2]   NA [1] 
LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40   33 
 (7 to 55) 
 NA [1]   21 
 (-3 to 45) 
 5 
 (-15 to 26) 
 -39 
 (-66 to -23) 
 3 
 (-42 to 45) 
 NA [1]   NA [1] 
FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59   7 
 (0 to 16) 
 -2 
 (-4 to 2) 
 3.6 
 (-5 to 11) 
 -4 
 (-9 to 6) 
 2 
 (-4 to 11) 
 7 
 (-2 to 13) 
 0 
 (-9 to 11) 
 0 
 (-16 to 7) 
FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44   4 
 (-4 to 11) 
 0 
 (-5 to 4) 
 1.8 
 (-4 to 11) 
 -5 
 (-11 to 0) 
 0 
 (-9 to 9) 
 4 
 (-5 to 14) 
 0 
 (-11 to 7) 
 -5 
 (-11 to 5) 
FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40   5 
 (-2 to 14) 
 -2 
 (-7 to 2) 
 1.8 
 (-5 to 11) 
 -9 
 (-16 to -4) 
 1 
 (-6 to 7) 
 2 
 (-10 to 12) 
 0 
 (-7 to 11) 
 -2 
 (-11 to 2) 
FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40   0 
 (-5 to 13) 
 0 
 (-5 to 2) 
 0 
 (-7 to 11) 
 -4 
 (-5 to 4) 
 0 
 (-9 to 5) 
 0 
 (-10 to 7) 
 7 
 (-2 to 16) 
 -14 
 (-21 to -8) 
FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0   4 
 (-5 to 11) 
 1 
 (-4 to 4) 
 0 
 (-9 to 9) 
 -2 
 (-7 to 5) 
 2 
 (-4 to 7) 
 -3 
 (-14 to 9) 
 21 
 (13 to 24) 
 0 
 (-2 to 2) 
FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40   2 
 (-7 to 11) 
 -0.9 
 (-4 to 1) 
 2.7 
 (-5 to 9.0) 
 -1.8 
 (-7 to 7) 
 2 
 (-4 to 11) 
 2 
 (-6 to 7) 
 20 
 (14 to 29) 
 -1 
 (-5 to 3) 
FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40   2 
 (-5 to 9) 
 4 
 (-8 to 9) 
 1.8 
 (-5 to 11) 
 0 
 (-5 to 5) 
 0 
 (-7 to 7) 
 5 
 (-5 to 16) 
 21 
 (14 to 25) 
 NA [1] 
FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40   0 
 (-5 to 7) 
 NA [1]   5.4 
 (-2 to 13) 
 2 
 (-2 to 5) 
 0 
 (-7 to 16) 
 11 
 (-2 to 20) 
 NA [1]   NA [1] 
[1] No participants were analyzed in this arm at this time point.
[2] Only one participant was analyzed in this arm at this time point.

No statistical analysis provided for Change From Baseline in the Indicated Clinical Chemistry Parameters at 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 ]

Measure Type Primary
Measure Title Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Measure Description Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Time Frame Weeks 120, 180, 204, 216, and 432  
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 who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Measured Values
   Final Analysis Population (APV30005) 
Participants Analyzed 
[Units: Participants]
 106 
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 
[Units: Milligrams per deciliter (mg/dl)]
Median (Inter-Quartile Range)
 
Triglycerides; Week 120, n=14   237 
 (187 to 372) 
Triglycerides; Week 180, n=14   248 
 (193 to 312) 
Triglycerides; Week 204, n=106   137 
 (95 to 204) 
Triglycerides; Week 216, n=102   120 
 (92 to 192) 
Triglycerides; Week 432, n=40   132 
 (76 to 182) 
Cholesterol; Week 120, n=14   202 
 (183 to 284) 
Cholesterol; Week 180, n=14   206 
 (20 to 226) 
Cholesterol; Week 204, n=106   201 
 (166 to 232) 
Cholesterol; Week 216, n=102   205 
 (169 to 239) 
Cholesterol; Week 432, n=40   192 
 (168 to 233) 
HDL Cholesterol; Week 120, n=14   40 
 (34 to 45) 
HDL Cholesterol; Week 180, n=14   36 
 (34 to 47) 
HDL Cholesterol; Week 204, n=106   52 
 (42 to 61) 
HDL Cholesterol; Week 216, n=102   51 
 (44 to 62) 
HDL Cholesterol; Week 432, n=40   51 
 (44 to 57) 
LDL Cholesterol; Week 120, n=14   40 
 (34 to 45) 
LDL Cholesterol; Week 180, n=14   40 
 (34 to 48) 
LDL Cholesterol; Week 204, n=106   52 
 (42 to 61) 
LDL Cholesterol; Week 216, n=102   51 
 (44 to 62) 
LDL Cholesterol; Week 432, n=40   51 
 (44 to 57) 
FBG; Week 120, n=14   86 
 (79 to 97) 
FBG; Week 180, n=14   88 
 (85 to 92) 
FBG; Week 204, n=106   92 
 (81 to 97) 
FBG; Week 216, n=104   90 
 (81 to 97) 
FBG Cholesterol; Week 432, n=40   92 
 (83 to 100) 

No statistical analysis provided for Median Values of the Indicated Clinical Chemistry Parameters at 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 ]

Measure Type Primary
Measure Title Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Measure Description blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time Frame Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216  
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 APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.

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

Measured Values
   FPV Population (APV30001)   NFV Population (APV30001)   FPV Population (APV30002)   NFV Population (APV30002) 
Participants Analyzed 
[Units: Participants]
 84   14   159   38 
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 
[Units: Ratio]
Median (Inter-Quartile Range)
       
Week 48, n=54, 14, 159, 38   0.1 
 (-0.4 to 0.8) 
 -0.4 
 (-1.0 to 0.6) 
 0.4 
 (-0.3 to 1.2) 
 0.1 
 (-0.3 to 0.5) 
Week 120, n=84, 14, 137, 33   -0.2 
 (-0.7 to 0.4) 
 -0.6 
 (-1.1 to -0.2) 
 -0.1 
 (-0.8 to 0.7) 
 -0.2 
 (-0.7 to 0.1) 
Week 180, n=73, 12, 114, 30   -0.4 
 (-1.1 to 0.2) 
 -0.6 
 (-1.6 to 0.1) 
 -0.3 
 (-1.0 to 0.4) 
 -0.3 
 (-1.3 to 0) 
Week 204, n=73, 12, 113, 23   -0.3 
 (-1.0 to 0.1) 
 -0.6 
 (-1.7 to 0.1) 
 -0.4 
 (-1.0 to 0.1) 
 -0.4 
 (-0.9 to 0.23) 
Week 216, n=76, 0, 111, 2   -0.5 
 (-1.0 to 0.2) 
 NA [1]   -0.5 
 (-1.1 to 0.1) 
 0.3 
 (0.1 to 0.6) 
[1] No participants were analyzed in this arm at this time point.

No statistical analysis provided for Change From Baseline in the Total Cholesterol/HDL Ratio at 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 ]

Measure Type Primary
Measure Title Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Measure Description Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time Frame Baseline (Day 1) and Weeks 48, 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.

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) 
Participants Analyzed 
[Units: Participants]
 61   65   45   7 
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 
[Units: Ratio]
Median (Inter-Quartile Range)
       
Week 48, n=61, 65 , 45, 7   -0.4 
 (-1.1 to 0.4) 
 -0.3 
 (-1.1 to 0.8) 
 -0.1 
 (-0.8 to 0.8) 
 -0.8 
 (-0.8 to -0.1) 
Week 96, n=47, 52, 42, 5   -0.5 
 (-1.4 to 0) 
 0.1 
 (-0.8 to 0.8) 
 -0.1 
 (-0.7 to 0.4) 
 -0.3 
 (-0.5 to 0) 
Week 132, n=40, 44, 41, 4   -0.4 
 (-1.5 to -0.1) 
 -0.6 
 (-1.6 to 0.5) 
 -0.2 
 (-1.1 to 1.0) 
 -1.5 
 (-2.7 to -0.3) 
Week 168, n=31, 40, 3, 5   -0.3 
 (-1.4 to 0.3) 
 0.2 
 (-1.0 to 0.5) 
 -0.6 
 (-1.0 to -0.4) 
 -1.4 
 (-1.4 to 0.1) 

No statistical analysis provided for Change From Baseline in the Total Cholesterol/HDL Ratio at 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 ]

Measure Type Primary
Measure Title Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Measure Description Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Time Frame Weeks 120, 180, 204, 216, and 432  
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 who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Measured Values
   Final Analysis Population (APV30005) 
Participants Analyzed 
[Units: Participants]
 106 
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 
[Units: Ratio]
Median (Inter-Quartile Range)
 
Week 120, n=14   5.5 
 (4.5 to 5.8) 
Week 180, n=14   5.5 
 (4.7 to 6.0) 
Week 204, n=106   3.7 
 (3.0 to 4.8) 
Week 216, n=102   3.5 
 (3.0 to 4.5) 
Week 432, n=40   4.0 
 (3.3 to 4.4) 

No statistical analysis provided for Median Value of the Total Cholesterol/HDL Ratio at 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 ]

Measure Type Primary
Measure Title Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Measure Description Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time Frame Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216  
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 APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.

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

Measured Values
   FPV Population (APV30001)   NFV Population (APV30001)   FPV Population (APV30002)   NFV Population (APV30002) 
Participants Analyzed 
[Units: Participants]
 118   17   217   47 
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 
[Units: Units per liter (U/L)]
Median (Inter-Quartile Range)
       
AST; Week 48, n=117, 17, 215, 47   -7 
 (-14 to -1) 
 -2 
 (-3 to 5) 
 -7 
 (-17 to -1) 
 0 
 (-5 to 5) 
AST; Week 120, n=96, 15, 182, 40   -8 
 (-19 to -1) 
 0 
 (-8 to 4) 
 -8 
 (-19 to -2) 
 1 
 (-3 to 4) 
AST; Week 180, n=80, 12, 154, 33   -10 
 (-19 to -3) 
 2 
 (-5 to 4) 
 -7 
 (-18 to -1) 
 -2 
 (-4 to 2) 
AST; Week 204, n=77, 12, 151, 27   -7 
 (-18 to -1) 
 3 
 (-4 to 6) 
 -7 
 (-18 to -1) 
 -2 
 (-4 to 2) 
AST; Week 216, n=79, 0, 142, 4   -9 
 (-16 to -1) 
 NA [1]   -7 
 (-17 to 0) 
 1 
 (-7 to 8) 
ALT; Week 48, n=117, 17, 216, 47   -5 
 (-21 to 2) 
 0 
 (-3 to 4) 
 -8 
 (-19 to 1) 
 2 
 (-2 to 8) 
ALT; Week 120, n=96, 15, 182, 40   -9 
 (-29 to 2) 
 -1 
 (-6 to 7) 
 -8 
 (-20 to 0) 
 4 
 (-6 to 8) 
ALT; Week 180, n=81, 12, 155, 33   -10 
 (-27 to -1) 
 3 
 (-3 to 5) 
 -6 
 (-19 to 5) 
 1 
 (-5 to 6) 
ALT; Week 204, n=77, 12, 152, 27   -10 
 (-26 to 0) 
 2 
 (-1 to 9) 
 -5 
 (-19 to 4) 
 -1 
 (-7 to 5) 
ALT; Week 216, n=79, 0, 142, 4   -10 
 (-27 to 2) 
 NA [1]   -6 
 (-18 to 2) 
 -3 
 (-11 to 9) 
Serum lipase; Week 48, n=118, 17, 217, 47   4 
 (-2 to 10) 
 1 
 (-8 to 5) 
 0 
 (-7 to 7) 
 -2 
 (-6 to 1) 
Serum lipase; Week 120, n=95, 15, 184, 40   4 
 (-4 to 9) 
 4 
 (-1 to 6) 
 -1 
 (-6 to 6) 
 2 
 (-4 to 7) 
Serum lipase; Week 180, n=81, 12, 156, 33   4 
 (-3 to 9) 
 -0.5 
 (-6 to 4) 
 1 
 (-5 to 6) 
 1 
 (-5 to 3) 
Serum lipase;Week 204, n=78, 12, 153, 27   3 
 (-4 to 10) 
 0 
 (-5 to 3) 
 1 
 (-5 to 7) 
 2 
 (-4 to 6) 
Serum lipase; Week 216, n=80, 0, 143, 4   5 
 (-2 to 11) 
 NA [1]   0 
 (-6 to 9) 
 -3 
 (-27 to 5) 
[1] No participants were analyzed in this arm at this time point.

No statistical analysis provided for Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at 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 ]

Measure Type Primary
Measure Title Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Measure Description Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time Frame Baseline (Day 1) and Weeks 48, 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.

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) 
Participants Analyzed 
[Units: Participants]
 73   78   83   65 
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 
[Units: Units per liter (U/L)]
Median (Inter-Quartile Range)
       
AST; Week 48, n=73, 78, 83, 65   -6 
 (-14 to 3) 
 -5 
 (-15 to -1) 
 1 
 (-3 to 4) 
 0 
 (-6 to 6) 
AST; Week 96, n=57, 63, 73, 49   -6 
 (-12 to 6) 
 -4 
 (-18 to 2) 
 1 
 (-3 to 3) 
 -1 
 (-9 to 4) 
AST; Week 132, n=50, 57, 64, 46   -6 
 (-13 to -1) 
 -4 
 (-14 to 2) 
 2 
 (-3 to 5) 
 1 
 (-5 to 8) 
AST; Week 168, n=45, 48, 20, 36   -6 
 (-14 to 1) 
 -6 
 (-17 to -1) 
 2 
 (-1 to 5) 
 -1 
 (-10 to 5) 
ALT; Week 48, n=70, 78, 83, 65   -2 
 (-13 to 4) 
 -6 
 (-21 to 1) 
 2 
 (-2 to 8) 
 0 
 (-9 to 12) 
ALT; Week 96, n=59, 63, 73, 49   -4 
 (-13 to 9) 
 -3 
 (-21 to 3) 
 2 
 (-3 to 6) 
 1 
 (-10 to 6) 
ALT; Week 132, n=51, 58, 64, 46   -2 
 (-17 to 8) 
 -4 
 (-18 to 3) 
 2 
 (-2 to 8) 
 2 
 (-10 to 8) 
ALT; Week 168, n=45, 48, 20, 37   -5 
 (-23 to 4) 
 -5 
 (-22 to 4) 
 6 
 (-1 to 9) 
 -3 
 (-16 to 6) 
Serum lipase; Week 48, n=72, 78, 57, 64   1 
 (-5 to 8) 
 2 
 (-4 to 9) 
 1 
 (-3 to 7) 
 1 
 (-4 to 6) 
Serum lipase; Week 96, n=59, 63, 52, 49   3 
 (-4 to 10) 
 4 
 (-5 to 12) 
 0 
 (-3 to 3) 
 3 
 (-4 to 11) 
Serum lipase; Week 132, n=52, 58, 47, 46   2 
 (-4 to 10) 
 4 
 (-1 to 13) 
 1 
 (-3 to 5) 
 2 
 (-4 to 11) 
Serum lipase; Week 168, n=45, 48, 7, 37   0 
 (-8 to 6) 
 2 
 (-1 to 11) 
 -5 
 (-14 to 8) 
 3 
 (-6 to 16) 

No statistical analysis provided for Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at 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 ]

Measure Type Primary
Measure Title Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Measure Description Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
Time Frame Weeks 120, 180, 204, 216, and 432  
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 who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Measured Values
   Final Analysis Population (APV30005) 
Participants Analyzed 
[Units: Participants]
 107 
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 
[Units: Units per liter (U/L)]
Median (Inter-Quartile Range)
 
AST; Week 120, n=14   18 
 (17 to 22) 
AST; Week 180, n=14   21 
 (19 to 23) 
AST; Week 204, n=107   20 
 (16 to 23) 
AST; Week 216, n=106   21 
 (18 to 25) 
AST; Week 432, n=41   21 
 (17 to 24) 
ALT; Week 120, n=14   18 
 (14 to 27) 
ALT; Week 180, n=14   32 
 (22 to 36) 
ALT; Week 204, n=107   19 
 (13 to 25) 
ALT; Week 216, n=106   19 
 (14 to 25) 
ALT; Week 432, n=41   19 
 (15 to 24) 
Serum lipase;Week 120, n=14   47 
 (31 to 53) 
Serum lipase; Week 180, n=14   39 
 (29 to 49) 
Serum lipase; Week 204, n=107   34 
 (27 to 44) 
Serum lipase; Week 216, n=106   36 
 (26 to 43) 
Serum lipase; Week 432, n=41   36 
 (30 to 47) 

No statistical analysis provided for Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at 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 ]

Measure Type Secondary
Measure Title 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)
Measure Description Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Time Frame Baseline and Weeks 48, 120, 180, and 216  
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 APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.

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

Measured Values
   FPV Population (APV30001)   NFV Population (APV30001)   FPV Population (APV30002)   NFV Population (APV30002) 
Participants Analyzed 
[Units: Participants]
 119   0   221   54 
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) 
[Units: Percentage of participants]
       
Baseline <400 copies, n=119, 219, 54; MD=F   1      0   61 
Week 48 <400 copies, n=119, 219, 54; MD=F   92      94   85 
Week 120 <400 copies, n=119, 219, 54; MD=F   76      77   69 
Week 180 <400 copies, n=119, 219, 54; MD=F   66      68   54 
Week 216 <400 copies, n=119, 219, 0; MD=F   62      61   NA [1] 
Baseline <400 copies, n=119, 219, 54; observed   1      0   61 
Week 48 <400 copies, n=118, 216, 49; observed   93      95   94 
Week 120 <400 copies, n=96, 181, 40; observed   95      93   93 
Week 180 <400 copies, n=82, 158, 34; observed   95      94   85 
Week 216 <400 copies, n=80, 142, 0; observed   93      94   NA [1] 
Baseline <50 copies, n=119, 219, 54; MD=F   1      0   46 
Week 48 <50 copies, n=119, 219, 54; MD=F   80      76   59 
Week 120 <50 copies, n=119, 219, 54; MD=F   71      66   61 
Week 180 <50 copies, n=119, 219, 54; MD=F   61      63   48 
Week 216 <50 copies, n=119, 219, 0; MD=F   58      58   NA [1] 
Baseline <50 copies, n=119, 219, 54; observed   1      0   46 
Week 48 <50 copies, n=118, 216, 49; observed   81      77   65 
Week 120 <50 copies, n=96, 181, 40; observed   88      80   83 
Week 180 <50 copies, n=82, 158, 34; observed   88      88   76 
Week 216 <50 copies, n=80, 142, 0; observed   86      89   NA [1] 
[1] No participants were analyzed in this arm at this time point.

No statistical analysis provided for 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)



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 ]

Measure Type Secondary
Measure Title 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)
Measure Description Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.
Time Frame Baseline and Weeks 12, 24, 48, 60, 96, and 132  
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 APV3005 having participated in Study APV30003 or other studies. 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) 
Participants Analyzed 
[Units: Participants]
 73   78   104   86 
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) 
[Units: Percentage of participants]
       
Baseline <400 copies, n=73, 78, 104, 86; MD=F   0   1   84   59 
Week 12 <400 copies, n=73, 78, 104, 86; MD=F   75   82   82   52 
Week 24 <400 copies, n=73, 78, 104, 86; MD=F   79   79   85   60 
Week 48 <400 copies, n=73, 78, 104, 86; MD=F   71   78   78   50 
Week 60 <400 copies, n=73, 78, 104, 86; MD=F   70   77   74   51 
Week 96 <400 copies, n=73, 78, 104, 86; MD=F   58   62   67   45 
Week 132 <400 copies, n=73, 78, 104, 86; MD=F   49   60   60   41 
Baseline <400 copies, n=73, 78, 92, 82; observed   0   1   95   62 
Week 12 <400 copies, n=69, 78, 92, 79; observed   80   82   92   57 
Week 24 <400 copies, n=73, 75, 93, 79; observed   79   83   95   66 
Week 48 <400 copies, n=73, 77, 85, 68; observed   71   79   95   63 
Week 60 <400 copies, n=71, 76, 81, 58; observed   72   79   95   76 
Week 96 <400 copies, n=60, 62, 75, 51; observed   70   77   93   76 
Week 132 <400 copies,n=50, 58, 65, 46; observed   72   81   95   76 
Baseline <50 copies, n=73, 78, 104, 86; MD=F   0   0   59   44 
Week 12 <50 copies, n=73, 78, 104, 86; MD=F   47   47   78   40 
Week 24 <50 copies, n=73, 78, 104, 86; MD=F   63   64   78   42 
Week 48 <50 copies, n=73, 78, 104, 86; MD=F   49   60   69   42 
Week 60 <50 copies, n=73, 78, 104, 86; MD=F   51   59   68   41 
Week 96 <50 copies, n=73, 78, 104, 86; MD=F   45   51   61   37 
Week 132 <50 copies, n=73, 78, 104, 86; MD=F   37   45   53   40 
Baseline <50 copies, n=73, 78, 92, 82; observed   0   0   66   46 
Week 12 <50 copies, n=69, 78, 92, 79; observed   49   47   88   43 
Week 24 <50 copies, n=73, 75, 93, 79; observed   63   67   87   46 
Week 48 <50 copies, n=73, 77, 85, 68; observed   49   61   85   53 
Week 60 <50 copies, n=71, 76, 81, 58; observed   52   61   88   60 
Week 96 <50 copies, n=60, 62, 75, 51; observed   55   65   84   63 
Week 132 <50 copies, n=50, 58, 65, 46; observed   54   60   85   74 

No statistical analysis provided for 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)



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 ]

Measure Type Secondary
Measure Title Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Measure Description Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.
Time Frame Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432  
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 who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.

Reporting Groups
  Description
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Measured Values
   Final Analysis Population (APV30005) 
Participants Analyzed 
[Units: Participants]
 101 
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) 
[Units: Percentage of participants]
 
Week 120 <50 copies, n=14; observed   93 
Week 180 <50 copies, n=14; observed   86 
Week 240 <50 copies, n=101; observed   87 
Week 300 <50 copies, n=82; observed   93 
Week 360 <50 copies, n=53; observed   89 
Week 420 <50 copies, n=52; observed   92 
Week 432 <50 copies, n=41; observed   93 

No statistical analysis provided for Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)



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 ]

Measure Type Secondary
Measure Title Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Measure Description Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Time Frame Baseline and Weeks 48, 120, 168, 180, 204, and 216  
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 APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.

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

Measured Values
   FPV Population (APV30001)   NFV Population (APV30001)   FPV Population (APV30002)   NFV Population (APV30002) 
Participants Analyzed 
[Units: Participants]
 119   18   219   52 
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis 
[Units: Cells per millimeters cubed (cells/mm^3)]
Median (Full Range)
       
Baseline, n=119, 18, 219, 52   211 
 (2 to 1136) 
 505 
 (179 to 1788) 
 167 
 (1 to 813) 
 297 
 (5 to 755) 
Week 48, n=117, 17, 211, 49   426 
 (40 to 1326) 
 499 
 (179 to 1367) 
 396 
 (58 to 1188) 
 377 
 (13 to 884) 
Week 120, n=95, 15, 177, 40   512 
 (116 to 1289) 
 613 
 (274 to 1406) 
 475 
 (90 to 1595) 
 439 
 (124 to 888) 
Week 168, n=81, 12, 160, 37   594 
 (147 to 1534) 
 608 
 (287 to 1069) 
 506 
 (67 to 1299) 
 422 
 (83 to 835) 
Week 180, n=78, 9, 153, 33   541 
 (418 to 765) 
 447 
 (180 to 768) 
 494 
 (113 to 1261) 
 413 
 (129 to 970) 
Week 204, n=75, 11, 145, 27   535 
 (377 to 709) 
 563 
 (226 to 998) 
 494 
 (110 to 1420) 
 459 
 (115 to 911) 
Week 216, n=77, 0, 138, 4   608 
 (477 to 846) 
 NA [1]   534 
 (117 to 1687) 
 548 
 (102 to 641) 
[1] No participants were analyzed in this arm at this time point.

No statistical analysis provided for Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis



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 ]

Measure Type Secondary
Measure Title Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Measure Description Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Time Frame Baseline and Weeks 24, 48, 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 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve 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) FFPV +/- 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) 
Participants Analyzed 
[Units: Participants]
 73   78   94   76 
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis 
[Units: Cells per millimeters cubed (cells/mm^3)]
Median (Full Range)
       
Baseline, n=72, 78, 94, 76   311 
 (6 to 1171) 
 304 
 (41 to 845) 
 477 
 (130 to 1224) 
 361 
 (6 to 1354) 
Week 24, n=71, 73, 92, 75   367 
 (69 to 1391) 
 348 
 (101 to 1051) 
 520 
 (128 to 1266) 
 399 
 (28 to 1120) 
Week 48, n=73, 77, 85, 68   374 
 (66 to 914) 
 386 
 (99 to 965) 
 582 
 (42 to 1194) 
 418 
 (10 to 1121) 
Week 96, n=58, 62, 73, 50   409 
 (179 to 868) 
 417 
 (82 to 744) 
 567 
 (82 to 1342) 
 463 
 (21 to 929) 
Week 132, n=50, 56, 64, 47   395 
 (120 to 1015) 
 386 
 (38 to 820) 
 642 
 (159 to 1193) 
 486 
 (16 to 1769) 
Week 168, n=40, 47, 20, 39   513 
 (133 to 1069) 
 409 
 (59 to 1097) 
 619 
 (260 to 1312) 
 460 
 (51 to 890) 

No statistical analysis provided for Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis



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 ]

Measure Type Secondary
Measure Title Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Measure Description Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Time Frame Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216  
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 particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.

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

Measured Values
   FPV Population (APV30001)   NFV Population (APV30001)   FPV Population (APV30002)   NFV Population (APV30002) 
Participants Analyzed 
[Units: Participants]
 119   18   221   54 
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 
[Units: Log 10 copies per milliliter]
Median (Full Range)
       
Baseline, n=119, 18, 221, 54   4.82 
 (1.69 to 7.4) 
 1.69 
 (1.69 to 5.6) 
 4.82 
 (2.65 to 7.29) 
 1.78 
 (1.69 to 5.66) 
Week 24, n=119, 17, 217, 51   1.69 
 (1.69 to 5.8) 
 1.69 
 (1.69 to 5.7) 
 1.69 
 (1.69 to 5.49) 
 1.69 
 (1.69 to 5.34) 
Week 48, n=118, 17, 218, 49   1.69 
 (1.69 to 5.9) 
 1.69 
 (1.69 to 5.4) 
 1.69 
 (1.69 to 5.03) 
 1.69 
 (1.69 to 4.13) 
Week 72, n=113, 15, 204, 46   1.69 
 (1.69 to 4.8) 
 1.69 
 (1.69 to 3.5) 
 1.69 
 (1.69 to 5.83) 
 1.69 
 (1.69 to 5.34) 
Week 96, n=106, 15, 192, 43   1.69 
 (1.69 to 4.7) 
 1.69 
 (1.69 to 3.6) 
 1.69 
 (1.69 to 5.38) 
 1.69 
 (1.69 to 1.69) 
Week 120, n=96, 15, 183, 40   1.69 
 (1.69 to 4.9) 
 1.69 
 (1.69 to 3.1) 
 1.69 
 (1.69 to 5.53) 
 1.69 
 (1.69 to 3.60) 
Week 144, n=89, 15, 173, 39   1.69 
 (1.69 to 4.2) 
 1.69 
 (1.69 to 3.9) 
 1.69 
 (1.69 to 5.38) 
 1.69 
 (1.69 to 3.82) 
Week 168, n=81, 14, 160, 38   1.69 
 (1.69 to 4.8) 
 1.69 
 (1.69 to 4.0) 
 1.69 
 (1.69 to 5.44) 
 1.69 
 (1.69 to 4.27) 
Week 180, n=82, 12, 159, 34   1.69 
 (1.69 to 4.7) 
 1.69 
 (1.69 to 3.3) 
 1.69 
 (1.69 to 4.71) 
 1.69 
 (1.69 to 3.95) 
Week 204, n=78, 12, 153, 27   1.69 
 (1.69 to 3.8) 
 1.69 
 (1.69 to 3.5) 
 1.69 
 (1.69 to 5.26) 
 1.69 
 (1.69 to 2.91) 
Week 216, n=80, 0, 143, 4   1.69 
 (1.69 to 5.4) 
 NA [1]   1.69 
 (1.69 to 5.59) 
 1.69 
 (1.69 to 1.69) 
[1] No participants were analyzed in this arm at this time point.

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

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) 
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 ]

Measure Type Secondary
Measure Title Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Measure Description Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Time Frame Weeks 180, 240, 300, 360, 420, and 432  
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 who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Measured Values
   Final Analysis Population (APV30005) 
Participants Analyzed 
[Units: Participants]
 101 
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 
[Units: Log 10 copies per milliliters]
Median (Full Range)
 
Week 180, n=14   1.7 
 (1.7 to 4.1) 
Week 240, n=101   1.7 
 (1.7 to 4.4) 
Week 300, n=82   1.7 
 (1.7 to 4.5) 
Week 360, n=53   1.7 
 (1.7 to 4.6) 
Week 420, n=52   1.7 
 (1.7 to 4.9) 
Week 432, n=41   1.7 
 (1.7 to 4.7) 

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

Measure Type Secondary
Measure Title Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
Measure Description The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.
Time Frame Baseline (Day 1) up to 31 January 2006 (up to Week 264)  
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 at least one dose of FPV or FPV/RTV in Study APV30005.

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

Measured Values
   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) 
Participants Analyzed 
[Units: Participants]
 119   18   221   54   73   78   104   86 
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline 
[Units: Participants]
               
CDC class A to CDC class C   0   0   3   0   0   1   0   0 
CDC class B to CDC class C   3   0   5   3   1   0   0   1 
CDC class C to new CDC class C   1   0   2   2   0   0   0   1 
CDC class A, B, or C to death (on treatment)   0   0   3   1   0   0   0   0 

No statistical analysis provided for Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline



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) ]

Measure Type Secondary
Measure Title Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
Measure Description The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.
Time Frame Baseline (Day 1) up to 31 January 2006 (up to Week 264)  
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 NFV in Studies APV30001 and APV30002.

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

Measured Values
   FPV Population (APV30001)   NFV Population (APV30001)   FPV Population (APV30002)   NFV Population (APV30002) 
Participants Analyzed 
[Units: Participants]
 119   18   221   54 
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions 
[Units: Participants]
       
Candidiasis, oropharyngeal   4   0   7   0 
Herpes zoster   0   0   3   3 
Diarrhea lasting >1 month   1   0   1   2 
Candidiasis, vulvovaginal   1   0   0   0 
Cervical dysplasia   1   0   0   0 
Fever lasting >1 month   1   0   0   0 
Hairy leukoplakia, oral   1   0   1   0 
Peripheral neuropathy   1   0   2   0 
Cytomegalovirus retinitis   1   0   0   0 
Herpes simplex   1   0   1   0 
Mycobacterium tuberculosis, any site   0   0   2   1 
Encepathopathy, HIV-related   0   0   1   0 
Kaposis's sarcoma, cutaneous   0   0   1   0 
Lymphoma,immunoblastic   0   0   1   0 
Mycobacterium avium complex/ M kansaii   0   0   1   0 
Pneumocystis carinii pneumonia   0   0   1   0 
Progressive multifocal leukoencephalopathy   0   0   1   0 
Toxoplasmosis of brain   1   0   0   0 
Non-CDC HIV-associated conditions   0   0   8   0 

No statistical analysis provided for Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions



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) ]

Measure Type Secondary
Measure Title Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Measure Description The number of participants with the indicated HIV-associated conditions were assessed.
Time Frame Baseline (Day 1) up to 31 January 2006 (up to Week 264)  
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/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.

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) 
Participants Analyzed 
[Units: Participants]
 73   78   104   86 
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions 
[Units: Participants]
       
Candidiasis, oropharyngeal   5   0   0   0 
Hairy leukoplakia, oral   1   0   0   1 
Peripheral neuropathy   1   1   0   0 
Diarrhea lasting >1 month   0   1   0   0 
Herpes Zoster   1   0   1   0 
Mycobacterium tuberculosis, any site   1   0   0   0 
Other, Non-CDC HIV associated condition   1   0   1   0 

No statistical analysis provided for Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions




  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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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



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