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

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT00296504
Collaborator
GlaxoSmithKline (Industry)
753
Enrollment
24
Locations
107
Duration (Months)
31.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Study Design

Study Type:
Interventional
Actual Enrollment :
753 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
Study Start Date :
Nov 1, 2001
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Outcome Measures

Primary Outcome Measures

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

    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.

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

    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.

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

    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).

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

    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).

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

    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).

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

    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).

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

    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.

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

    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).

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

    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).

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

    Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.

Secondary Outcome Measures

  1. 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) [Baseline and Weeks 48, 120, 180, and 216]

    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.

  2. 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) [Baseline and Weeks 12, 24, 48, 60, 96, and 132]

    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.

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

    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.

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

    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.

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

    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.

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

    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  7. Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 [Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168]

    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

  8. Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 [Weeks 180, 240, 300, 360, 420, and 432]

    Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.

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

    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.

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

    The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.

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

    The number of participants with the indicated HIV-associated conditions were assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).

  • Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.

Exclusion Criteria:

  • Permanent discontinuation of GW433908 in a previous study due to intolerance.

  • An active CDC Class C Event.

  • Any condition which, in the opinion of the investigator, would preclude a subject from participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Fountain Valley California United States 92708
2 GSK Investigational Site San Francisco California United States 94115-1931
3 GSK Investigational Site Denver Colorado United States 80262
4 GSK Investigational Site Fort Lauderdale Florida United States 33145
5 GSK Investigational Site Orlando Florida United States 32804
6 GSK Investigational Site Orlando Florida United States 32806
7 GSK Investigational Site Sarasota Florida United States 34239
8 GSK Investigational Site Tampa Florida United States 33614
9 GSK Investigational Site Manhasset New York United States 11030
10 GSK Investigational Site Galveston Texas United States 77555-1188
11 GSK Investigational Site Campinas São Paulo Brazil 13083970
12 GSK Investigational Site Santiago Región Metro De Santiago Chile
13 GSK Investigational Site Le Kremlin Bicêtre Cedex France 94275
14 GSK Investigational Site Marseille France 13005
15 GSK Investigational Site Paris Cedex 10 France 75475
16 GSK Investigational Site Paris Cedex 20 France 75970
17 GSK Investigational Site Vandoeuvre Les Nancy Cedex France 54511
18 GSK Investigational Site Villejuif Cedex France 94805
19 GSK Investigational Site Genova Liguria Italy 16128
20 GSK Investigational Site Coimbra Portugal 3000-075
21 GSK Investigational Site Badajoz Spain 6080
22 GSK Investigational Site Barcelona Spain 08036
23 GSK Investigational Site London United Kingdom NW3 2QG
24 GSK Investigational Site London United Kingdom SE1 7EH

Sponsors and Collaborators

  • ViiV Healthcare
  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00296504
Other Study ID Numbers:
  • APV30005
First Posted:
Feb 27, 2006
Last Update Posted:
Apr 19, 2013
Last Verified:
Jun 1, 2012
Keywords provided by ViiV Healthcare
antiretroviral therapy naive subjects
fosamprenavir
HIV-1
protease inhibitor
pro-drug
antiretroviral therapy
LEXIVA
AGENERASE
GW433908
amprenavir
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Ritonavir
Fosamprenavir

Study Results

Participant Flow

Recruitment Details 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 Detail 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.
Arm/Group Title 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)
Arm/Group Description Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Period Title: Interim Analysis
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
Period Title: Interim Analysis
STARTED 0 0 0 0 0 0 0 0 111
COMPLETED 0 0 0 0 0 0 0 0 90
NOT COMPLETED 0 0 0 0 0 0 0 0 21

Baseline Characteristics

Arm/Group Title 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
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study Total of all reporting groups
Overall Participants 119 18 221 54 73 78 104 86 753
Age, Customized (years) [Mean (Full Range) ]
Mean (Full Range) [years]
36.3
35.8
37.7
36.2
41.9
42.3
39.3
40.2
38.7
Sex: Female, Male (Count of Participants)
Female
36
30.3%
9
50%
63
28.5%
23
42.6%
9
12.3%
12
15.4%
24
23.1%
22
25.6%
198
26.3%
Male
83
69.7%
9
50%
158
71.5%
31
57.4%
64
87.7%
66
84.6%
80
76.9%
64
74.4%
555
73.7%
Race/Ethnicity, Customized (participants) [Number]
White
34
28.6%
1
5.6%
109
49.3%
14
25.9%
59
80.8%
56
71.8%
44
42.3%
77
89.5%
394
52.3%
Black
35
29.4%
6
33.3%
86
38.9%
34
63%
10
13.7%
14
17.9%
34
32.7%
7
8.1%
226
30%
Asian
1
0.8%
0
0%
4
1.8%
0
0%
1
1.4%
1
1.3%
1
1%
0
0%
8
1.1%
American Hispanic
49
41.2%
11
61.1%
16
7.2%
2
3.7%
3
4.1%
7
9%
23
22.1%
2
2.3%
113
15%
Other: Race Not Specified
0
0%
0
0%
6
2.7%
4
7.4%
0
0%
0
0%
2
1.9%
0
0%
12
1.6%
Number of Participants with the Indicated CDC Classification of HIV Infection (participants) [Number]
Asymptomatic or lymphadenopathy
81
68.1%
16
88.9%
124
56.1%
13
24.1%
26
35.6%
30
38.5%
76
73.1%
29
33.7%
395
52.5%
Symptomatic, not AIDS
17
14.3%
1
5.6%
48
21.7%
23
42.6%
21
28.8%
24
30.8%
23
22.1%
18
20.9%
175
23.2%
Acquired Immune Deficiency Syndrome (AIDS)
21
17.6%
1
5.6%
49
22.2%
18
33.3%
26
35.6%
24
30.8%
5
4.8%
39
45.3%
183
24.3%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Any Adverse Event (AE): Interim Analysis
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)

Outcome Measure Data

Analysis Population Description
All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
Arm/Group Title 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)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 119 18 221 54 73 78 104 86
Number [participants]
117
98.3%
16
88.9%
215
97.3%
52
96.3%
72
98.6%
75
96.2%
95
91.3%
68
79.1%
2. Primary Outcome
Title Number of Participants With Any Adverse Event (AE): Final Analysis
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

Outcome Measure Data

Analysis Population Description
All participants who remained in the study after January 31, 2006.
Arm/Group Title Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Measure Participants 111
Number [participants]
95
79.8%
3. Primary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 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)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 92 14 159 38 61 65 77 59
Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59
10
-41
51
20
9
14
5
-54
Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44
9
-48
47
15
16
34
-5
7
Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40
15
-33
43
-4
13
22
-4
-73
Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40
2
-2
47
18
14
18
6
-129
Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33
3
-12
27
4
29
42
5
-167
Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40
8
-41
37
18
13
8
-2
-170
Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40
2
-36
43
12
4
49
12
NA
Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
7
NA
39
98
-7
66
NA
NA
Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59
52
3
53
10
14
13
8
22
Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44
39
-3
46
8
12
10
13
19
Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40
42
-9
50
9
11
22
13
32
Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40
43
14
47
13
14
-4
2
12
Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33
56
6
47
21
18
9
6
28
Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40
54
-4
53
19
3
9
5
43
Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40
52
5
53
22
-3
11
-5
NA
Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
52
NA
47
30
-65
28
NA
NA
HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59,
10
-0.2
8
3
6
2
3
8
HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44
12
8
12
4
6
2
4
5
HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40
12
5
12
7
8
4
5
10
HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40
13
6
12
9
6
5
3
16
HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0
17
13
17
12
8
2
10
5
HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40
17
4
15
10
7
4
12
18
HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40
16
10
17
15
6
2
3
NA
HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
16
NA
17
4
3
6
NA
NA
LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48
32
10
30
0
2
-1
3
17
LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37
25
-2
21
1
3
0
7
15
LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40
27
-4
21
-2
-6
12
3
38
LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34
25
11
24
4
-4
-2
0
14
LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0
37
-5
18
5
-3
-6
-1
48
LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40
27
1
23
2
-2
4
-7
54
LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40
35
5
22
13
-14
1
-45
NA
LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40
33
NA
21
5
-39
3
NA
NA
FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59
7
-2
3.6
-4
2
7
0
0
FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44
4
0
1.8
-5
0
4
0
-5
FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40
5
-2
1.8
-9
1
2
0
-2
FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40
0
0
0
-4
0
0
7
-14
FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0
4
1
0
-2
2
-3
21
0
FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40
2
-0.9
2.7
-1.8
2
2
20
-1
FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40
2
4
1.8
0
0
5
21
NA
FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40
0
NA
5.4
2
0
11
NA
NA
4. Primary Outcome
Title Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
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

Outcome Measure Data

Analysis Population Description
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Measure Participants 106
Triglycerides; Week 120, n=14
237
Triglycerides; Week 180, n=14
248
Triglycerides; Week 204, n=106
137
Triglycerides; Week 216, n=102
120
Triglycerides; Week 432, n=40
132
Cholesterol; Week 120, n=14
202
Cholesterol; Week 180, n=14
206
Cholesterol; Week 204, n=106
201
Cholesterol; Week 216, n=102
205
Cholesterol; Week 432, n=40
192
HDL Cholesterol; Week 120, n=14
40
HDL Cholesterol; Week 180, n=14
36
HDL Cholesterol; Week 204, n=106
52
HDL Cholesterol; Week 216, n=102
51
HDL Cholesterol; Week 432, n=40
51
LDL Cholesterol; Week 120, n=14
40
LDL Cholesterol; Week 180, n=14
40
LDL Cholesterol; Week 204, n=106
52
LDL Cholesterol; Week 216, n=102
51
LDL Cholesterol; Week 432, n=40
51
FBG; Week 120, n=14
86
FBG; Week 180, n=14
88
FBG; Week 204, n=106
92
FBG; Week 216, n=104
90
FBG Cholesterol; Week 432, n=40
92
5. Primary Outcome
Title Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV Population (APV30001) NFV Population (APV30001) FPV Population (APV30002) NFV Population (APV30002)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Measure Participants 84 14 159 38
Week 48, n=54, 14, 159, 38
0.1
-0.4
0.4
0.1
Week 120, n=84, 14, 137, 33
-0.2
-0.6
-0.1
-0.2
Week 180, n=73, 12, 114, 30
-0.4
-0.6
-0.3
-0.3
Week 204, n=73, 12, 113, 23
-0.3
-0.6
-0.4
-0.4
Week 216, n=76, 0, 111, 2
-0.5
NA
-0.5
0.3
6. Primary Outcome
Title Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV/RTV QD Population (APV30003) FPV/RTV BID Population (APV30003) PI-Naïve Population (Other Studies) PI-Experienced Population (Other Studies)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 61 65 45 7
Week 48, n=61, 65 , 45, 7
-0.4
-0.3
-0.1
-0.8
Week 96, n=47, 52, 42, 5
-0.5
0.1
-0.1
-0.3
Week 132, n=40, 44, 41, 4
-0.4
-0.6
-0.2
-1.5
Week 168, n=31, 40, 3, 5
-0.3
0.2
-0.6
-1.4
7. Primary Outcome
Title Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
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

Outcome Measure Data

Analysis Population Description
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Measure Participants 106
Week 120, n=14
5.5
Week 180, n=14
5.5
Week 204, n=106
3.7
Week 216, n=102
3.5
Week 432, n=40
4.0
8. Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV Population (APV30001) NFV Population (APV30001) FPV Population (APV30002) NFV Population (APV30002)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Measure Participants 118 17 217 47
AST; Week 48, n=117, 17, 215, 47
-7
-2
-7
0
AST; Week 120, n=96, 15, 182, 40
-8
0
-8
1
AST; Week 180, n=80, 12, 154, 33
-10
2
-7
-2
AST; Week 204, n=77, 12, 151, 27
-7
3
-7
-2
AST; Week 216, n=79, 0, 142, 4
-9
NA
-7
1
ALT; Week 48, n=117, 17, 216, 47
-5
0
-8
2
ALT; Week 120, n=96, 15, 182, 40
-9
-1
-8
4
ALT; Week 180, n=81, 12, 155, 33
-10
3
-6
1
ALT; Week 204, n=77, 12, 152, 27
-10
2
-5
-1
ALT; Week 216, n=79, 0, 142, 4
-10
NA
-6
-3
Serum lipase; Week 48, n=118, 17, 217, 47
4
1
0
-2
Serum lipase; Week 120, n=95, 15, 184, 40
4
4
-1
2
Serum lipase; Week 180, n=81, 12, 156, 33
4
-0.5
1
1
Serum lipase;Week 204, n=78, 12, 153, 27
3
0
1
2
Serum lipase; Week 216, n=80, 0, 143, 4
5
NA
0
-3
9. Primary Outcome
Title Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV/RTV QD Population (APV30003) FPV/RTV BID Population (APV30003) PI-Naïve Population (Other Studies) PI-Experienced Population (Other Studies)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 73 78 83 65
AST; Week 48, n=73, 78, 83, 65
-6
-5
1
0
AST; Week 96, n=57, 63, 73, 49
-6
-4
1
-1
AST; Week 132, n=50, 57, 64, 46
-6
-4
2
1
AST; Week 168, n=45, 48, 20, 36
-6
-6
2
-1
ALT; Week 48, n=70, 78, 83, 65
-2
-6
2
0
ALT; Week 96, n=59, 63, 73, 49
-4
-3
2
1
ALT; Week 132, n=51, 58, 64, 46
-2
-4
2
2
ALT; Week 168, n=45, 48, 20, 37
-5
-5
6
-3
Serum lipase; Week 48, n=72, 78, 57, 64
1
2
1
1
Serum lipase; Week 96, n=59, 63, 52, 49
3
4
0
3
Serum lipase; Week 132, n=52, 58, 47, 46
2
4
1
2
Serum lipase; Week 168, n=45, 48, 7, 37
0
2
-5
3
10. Primary Outcome
Title Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
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

Outcome Measure Data

Analysis Population Description
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Measure Participants 107
AST; Week 120, n=14
18
AST; Week 180, n=14
21
AST; Week 204, n=107
20
AST; Week 216, n=106
21
AST; Week 432, n=41
21
ALT; Week 120, n=14
18
ALT; Week 180, n=14
32
ALT; Week 204, n=107
19
ALT; Week 216, n=106
19
ALT; Week 432, n=41
19
Serum lipase;Week 120, n=14
47
Serum lipase; Week 180, n=14
39
Serum lipase; Week 204, n=107
34
Serum lipase; Week 216, n=106
36
Serum lipase; Week 432, n=41
36
11. Secondary Outcome
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)
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV Population (APV30001) NFV Population (APV30001) FPV Population (APV30002) NFV Population (APV30002)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Measure Participants 119 0 221 54
Baseline <400 copies, n=119, 219, 54; MD=F
1
0.8%
0
0%
61
27.6%
Week 48 <400 copies, n=119, 219, 54; MD=F
92
77.3%
94
522.2%
85
38.5%
Week 120 <400 copies, n=119, 219, 54; MD=F
76
63.9%
77
427.8%
69
31.2%
Week 180 <400 copies, n=119, 219, 54; MD=F
66
55.5%
68
377.8%
54
24.4%
Week 216 <400 copies, n=119, 219, 0; MD=F
62
52.1%
61
338.9%
NA
NaN
Baseline <400 copies, n=119, 219, 54; observed
1
0.8%
0
0%
61
27.6%
Week 48 <400 copies, n=118, 216, 49; observed
93
78.2%
95
527.8%
94
42.5%
Week 120 <400 copies, n=96, 181, 40; observed
95
79.8%
93
516.7%
93
42.1%
Week 180 <400 copies, n=82, 158, 34; observed
95
79.8%
94
522.2%
85
38.5%
Week 216 <400 copies, n=80, 142, 0; observed
93
78.2%
94
522.2%
NA
NaN
Baseline <50 copies, n=119, 219, 54; MD=F
1
0.8%
0
0%
46
20.8%
Week 48 <50 copies, n=119, 219, 54; MD=F
80
67.2%
76
422.2%
59
26.7%
Week 120 <50 copies, n=119, 219, 54; MD=F
71
59.7%
66
366.7%
61
27.6%
Week 180 <50 copies, n=119, 219, 54; MD=F
61
51.3%
63
350%
48
21.7%
Week 216 <50 copies, n=119, 219, 0; MD=F
58
48.7%
58
322.2%
NA
NaN
Baseline <50 copies, n=119, 219, 54; observed
1
0.8%
0
0%
46
20.8%
Week 48 <50 copies, n=118, 216, 49; observed
81
68.1%
77
427.8%
65
29.4%
Week 120 <50 copies, n=96, 181, 40; observed
88
73.9%
80
444.4%
83
37.6%
Week 180 <50 copies, n=82, 158, 34; observed
88
73.9%
88
488.9%
76
34.4%
Week 216 <50 copies, n=80, 142, 0; observed
86
72.3%
89
494.4%
NA
NaN
12. Secondary Outcome
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)
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV/RTV QD Population (APV30003) FPV/RTV BID Population (APV30003) PI-Naïve Population (Other Studies) PI-Experienced Population (Other Studies)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 73 78 104 86
Baseline <400 copies, n=73, 78, 104, 86; MD=F
0
0%
1
5.6%
84
38%
59
109.3%
Week 12 <400 copies, n=73, 78, 104, 86; MD=F
75
63%
82
455.6%
82
37.1%
52
96.3%
Week 24 <400 copies, n=73, 78, 104, 86; MD=F
79
66.4%
79
438.9%
85
38.5%
60
111.1%
Week 48 <400 copies, n=73, 78, 104, 86; MD=F
71
59.7%
78
433.3%
78
35.3%
50
92.6%
Week 60 <400 copies, n=73, 78, 104, 86; MD=F
70
58.8%
77
427.8%
74
33.5%
51
94.4%
Week 96 <400 copies, n=73, 78, 104, 86; MD=F
58
48.7%
62
344.4%
67
30.3%
45
83.3%
Week 132 <400 copies, n=73, 78, 104, 86; MD=F
49
41.2%
60
333.3%
60
27.1%
41
75.9%
Baseline <400 copies, n=73, 78, 92, 82; observed
0
0%
1
5.6%
95
43%
62
114.8%
Week 12 <400 copies, n=69, 78, 92, 79; observed
80
67.2%
82
455.6%
92
41.6%
57
105.6%
Week 24 <400 copies, n=73, 75, 93, 79; observed
79
66.4%
83
461.1%
95
43%
66
122.2%
Week 48 <400 copies, n=73, 77, 85, 68; observed
71
59.7%
79
438.9%
95
43%
63
116.7%
Week 60 <400 copies, n=71, 76, 81, 58; observed
72
60.5%
79
438.9%
95
43%
76
140.7%
Week 96 <400 copies, n=60, 62, 75, 51; observed
70
58.8%
77
427.8%
93
42.1%
76
140.7%
Week 132 <400 copies,n=50, 58, 65, 46; observed
72
60.5%
81
450%
95
43%
76
140.7%
Baseline <50 copies, n=73, 78, 104, 86; MD=F
0
0%
0
0%
59
26.7%
44
81.5%
Week 12 <50 copies, n=73, 78, 104, 86; MD=F
47
39.5%
47
261.1%
78
35.3%
40
74.1%
Week 24 <50 copies, n=73, 78, 104, 86; MD=F
63
52.9%
64
355.6%
78
35.3%
42
77.8%
Week 48 <50 copies, n=73, 78, 104, 86; MD=F
49
41.2%
60
333.3%
69
31.2%
42
77.8%
Week 60 <50 copies, n=73, 78, 104, 86; MD=F
51
42.9%
59
327.8%
68
30.8%
41
75.9%
Week 96 <50 copies, n=73, 78, 104, 86; MD=F
45
37.8%
51
283.3%
61
27.6%
37
68.5%
Week 132 <50 copies, n=73, 78, 104, 86; MD=F
37
31.1%
45
250%
53
24%
40
74.1%
Baseline <50 copies, n=73, 78, 92, 82; observed
0
0%
0
0%
66
29.9%
46
85.2%
Week 12 <50 copies, n=69, 78, 92, 79; observed
49
41.2%
47
261.1%
88
39.8%
43
79.6%
Week 24 <50 copies, n=73, 75, 93, 79; observed
63
52.9%
67
372.2%
87
39.4%
46
85.2%
Week 48 <50 copies, n=73, 77, 85, 68; observed
49
41.2%
61
338.9%
85
38.5%
53
98.1%
Week 60 <50 copies, n=71, 76, 81, 58; observed
52
43.7%
61
338.9%
88
39.8%
60
111.1%
Week 96 <50 copies, n=60, 62, 75, 51; observed
55
46.2%
65
361.1%
84
38%
63
116.7%
Week 132 <50 copies, n=50, 58, 65, 46; observed
54
45.4%
60
333.3%
85
38.5%
74
137%
13. Secondary Outcome
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)
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Measure Participants 101
Week 120 <50 copies, n=14; observed
93
78.2%
Week 180 <50 copies, n=14; observed
86
72.3%
Week 240 <50 copies, n=101; observed
87
73.1%
Week 300 <50 copies, n=82; observed
93
78.2%
Week 360 <50 copies, n=53; observed
89
74.8%
Week 420 <50 copies, n=52; observed
92
77.3%
Week 432 <50 copies, n=41; observed
93
78.2%
14. Secondary Outcome
Title Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV Population (APV30001) NFV Population (APV30001) FPV Population (APV30002) NFV Population (APV30002)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Measure Participants 119 18 219 52
Baseline, n=119, 18, 219, 52
211
505
167
297
Week 48, n=117, 17, 211, 49
426
499
396
377
Week 120, n=95, 15, 177, 40
512
613
475
439
Week 168, n=81, 12, 160, 37
594
608
506
422
Week 180, n=78, 9, 153, 33
541
447
494
413
Week 204, n=75, 11, 145, 27
535
563
494
459
Week 216, n=77, 0, 138, 4
608
NA
534
548
15. Secondary Outcome
Title Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV/RTV QD Population (APV30003) FPV/RTV BID Population (APV30003) PI-Naïve Population (Other Studies) PI-Experienced Population (Other Studies)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 73 78 94 76
Baseline, n=72, 78, 94, 76
311
304
477
361
Week 24, n=71, 73, 92, 75
367
348
520
399
Week 48, n=73, 77, 85, 68
374
386
582
418
Week 96, n=58, 62, 73, 50
409
417
567
463
Week 132, n=50, 56, 64, 47
395
386
642
486
Week 168, n=40, 47, 20, 39
513
409
619
460
16. Secondary Outcome
Title Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV Population (APV30001) NFV Population (APV30001) FPV Population (APV30002) NFV Population (APV30002)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Measure Participants 119 18 221 54
Baseline, n=119, 18, 221, 54
4.82
1.69
4.82
1.78
Week 24, n=119, 17, 217, 51
1.69
1.69
1.69
1.69
Week 48, n=118, 17, 218, 49
1.69
1.69
1.69
1.69
Week 72, n=113, 15, 204, 46
1.69
1.69
1.69
1.69
Week 96, n=106, 15, 192, 43
1.69
1.69
1.69
1.69
Week 120, n=96, 15, 183, 40
1.69
1.69
1.69
1.69
Week 144, n=89, 15, 173, 39
1.69
1.69
1.69
1.69
Week 168, n=81, 14, 160, 38
1.69
1.69
1.69
1.69
Week 180, n=82, 12, 159, 34
1.69
1.69
1.69
1.69
Week 204, n=78, 12, 153, 27
1.69
1.69
1.69
1.69
Week 216, n=80, 0, 143, 4
1.69
NA
1.69
1.69
17. Secondary Outcome
Title Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
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

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title FPV/RTV QD Population (APV30003) FPV/RTV BID Population (APV30003) PI-Naïve Population (Other Studies) PI-Experienced Population (Other Studies)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 73 78 93 82
Baseline, n=73, 78, 92, 82
3.96
4.06
1.7
1.81
Week 12, n=69, 78, 92, 79
1.7
1.81
1.7
2.03
Week 24, n=73, 75, 93, 79
1.69
1.69
1.7
1.9
Week 48, n=73, 77, 85, 68
1.71
1.69
1.7
1.7
Week 72, n=65, 73, 80, 53
1.72
1.69
1.7
1.7
Week 96, n=60, 62, 75, 51
1.69
1.69
1.7
1.7
Week 132, n=50, 58, 65, 46
1.69
1.69
1.7
1.7
Week 168, n=44, 48, 20, 39
1.69
1.69
1.7
1.7
18. Secondary Outcome
Title Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
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

Outcome Measure Data

Analysis Population Description
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Measure Participants 101
Week 180, n=14
1.7
Week 240, n=101
1.7
Week 300, n=82
1.7
Week 360, n=53
1.7
Week 420, n=52
1.7
Week 432, n=41
1.7
19. Secondary Outcome
Title Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
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)

Outcome Measure Data

Analysis Population Description
All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
Arm/Group Title 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)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 119 18 221 54 73 78 104 86
CDC class A to CDC class C
0
0%
0
0%
3
1.4%
0
0%
0
0%
1
1.3%
0
0%
0
0%
CDC class B to CDC class C
3
2.5%
0
0%
5
2.3%
3
5.6%
1
1.4%
0
0%
0
0%
1
1.2%
CDC class C to new CDC class C
1
0.8%
0
0%
2
0.9%
2
3.7%
0
0%
0
0%
0
0%
1
1.2%
CDC class A, B, or C to death (on treatment)
0
0%
0
0%
3
1.4%
1
1.9%
0
0%
0
0%
0
0%
0
0%
20. Secondary Outcome
Title Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
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)

Outcome Measure Data

Analysis Population Description
All participants receiving FPV or NFV in Studies APV30001 and APV30002.
Arm/Group Title FPV Population (APV30001) NFV Population (APV30001) FPV Population (APV30002) NFV Population (APV30002)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Measure Participants 119 18 221 54
Candidiasis, oropharyngeal
4
3.4%
0
0%
7
3.2%
0
0%
Herpes zoster
0
0%
0
0%
3
1.4%
3
5.6%
Diarrhea lasting >1 month
1
0.8%
0
0%
1
0.5%
2
3.7%
Candidiasis, vulvovaginal
1
0.8%
0
0%
0
0%
0
0%
Cervical dysplasia
1
0.8%
0
0%
0
0%
0
0%
Fever lasting >1 month
1
0.8%
0
0%
0
0%
0
0%
Hairy leukoplakia, oral
1
0.8%
0
0%
1
0.5%
0
0%
Peripheral neuropathy
1
0.8%
0
0%
2
0.9%
0
0%
Cytomegalovirus retinitis
1
0.8%
0
0%
0
0%
0
0%
Herpes simplex
1
0.8%
0
0%
1
0.5%
0
0%
Mycobacterium tuberculosis, any site
0
0%
0
0%
2
0.9%
1
1.9%
Encepathopathy, HIV-related
0
0%
0
0%
1
0.5%
0
0%
Kaposis's sarcoma, cutaneous
0
0%
0
0%
1
0.5%
0
0%
Lymphoma,immunoblastic
0
0%
0
0%
1
0.5%
0
0%
Mycobacterium avium complex/ M kansaii
0
0%
0
0%
1
0.5%
0
0%
Pneumocystis carinii pneumonia
0
0%
0
0%
1
0.5%
0
0%
Progressive multifocal leukoencephalopathy
0
0%
0
0%
1
0.5%
0
0%
Toxoplasmosis of brain
1
0.8%
0
0%
0
0%
0
0%
Non-CDC HIV-associated conditions
0
0%
0
0%
8
3.6%
0
0%
21. Secondary Outcome
Title Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
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)

Outcome Measure Data

Analysis Population Description
All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.
Arm/Group Title FPV/RTV QD Population (APV30003) FPV/RTV BID Population (APV30003) PI-Naïve Population (Other Studies) PI-Experienced Population (Other Studies)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Measure Participants 73 78 104 86
Candidiasis, oropharyngeal
5
4.2%
0
0%
0
0%
0
0%
Hairy leukoplakia, oral
1
0.8%
0
0%
0
0%
1
1.9%
Peripheral neuropathy
1
0.8%
1
5.6%
0
0%
0
0%
Diarrhea lasting >1 month
0
0%
1
5.6%
0
0%
0
0%
Herpes Zoster
1
0.8%
0
0%
1
0.5%
0
0%
Mycobacterium tuberculosis, any site
1
0.8%
0
0%
0
0%
0
0%
Other, Non-CDC HIV associated condition
1
0.8%
0
0%
1
0.5%
0
0%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title 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) Final Analysis Population (APV30005)
Arm/Group Description FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
All Cause Mortality
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) Final Analysis Population (APV30005)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
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) Final Analysis Population (APV30005)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 33/119 (27.7%) 1/18 (5.6%) 62/221 (28.1%) 7/54 (13%) 20/73 (27.4%) 14/78 (17.9%) 7/104 (6.7%) 13/86 (15.1%) 15/111 (13.5%)
Blood and lymphatic system disorders
Anaemia 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 2/86 (2.3%) 1/111 (0.9%)
Cardiac disorders
Cardiomegaly 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Coronary artery disease 1/119 (0.8%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Angina unstable 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Myocardial infarction 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Tachycardia 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Cardiac failure congestive 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Eye disorders
Pterygium 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Gastrointestinal disorders
Abdominal pain 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Vomiting 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Diarrhoea 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Nausea 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pancreatitis acute 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Anal stenosis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Colitis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Inguinal hernia 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pancreatitis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
General disorders
Chest pain 1/119 (0.8%) 0/18 (0%) 5/221 (2.3%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Chest discomfort 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Feeling hot 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pyrexia 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Malaise 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Hepatobiliary disorders
Cholelithiasis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Immune system disorders
Drug hypersensitivity 11/119 (9.2%) 0/18 (0%) 16/221 (7.2%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Infections and infestations
Anogenital warts 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Cellulitis of male external genital organ 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Enterocolitis infectious 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Gastroenteritis 1/119 (0.8%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Gastroenteritis salmonella 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Herpes simplex 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Orchitis 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Peritonsillar abscess 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pneumocystis jiroveci pneumonia 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pneumonia 1/119 (0.8%) 0/18 (0%) 3/221 (1.4%) 0/54 (0%) 2/73 (2.7%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Scrotal abscess 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Sepsis 1/119 (0.8%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Syphilis 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Viral infection 1/119 (0.8%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Lobar pneumonia 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Osteomyelitis 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pyelonephritis 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Appendicitis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Arthritis bacterial 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Bronchitis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Bronchopneumonia 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Cellulitis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Erysipelas 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Influenza 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Localised infection 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Meningitis viral 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pneumonia primary atypical 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Respiratory tract infection 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Superinfection lung 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Tuberculosis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Urinary tract infection 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Abscess limb 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Meningitis 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Hepatitis C 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Herpes zoster 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Leishmaniasis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Perianal abscess 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Upper respiratory tract infection 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Visceral leishmaniasis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Perirectal abscess 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Urinary tract infection pseudomonal 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Pneumonia bacterial 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Subcutaneous abscess 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Malaria 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Injury, poisoning and procedural complications
Joint dislocation 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Contusion 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Facial bones fracture 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Fall 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Forearm fracture 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Gastrointestinal injury 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Hand fracture 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Head injury 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Jaw fracture 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Overdose 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Patella fracture 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Road traffic accident 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Wrist fracture 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Alcohol poisoning 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Thermal burn 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Anastomotic leak 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Collapse of lung 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/0 (NaN) 0/111 (0%)
Injury 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Fibula fracture 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Tendon rupture 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Tibia fracture 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Ankle fracture 0/119 (0%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Arthropod bite 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Lower limb fracture 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Soft tissue injury 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Investigations
Alanine aminotransferase increased 1/119 (0.8%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Aspartate aminotransferase increased 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Electrocardiogram abnormal 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Lipase increased 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Haemoglobin decreased 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Liver function test abnormal 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Metabolism and nutrition disorders
Diabetes mellitus 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Dehydration 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Hyperthyroidism 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Thyroiditis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Musculoskeletal and connective tissue disorders
Joint effusion 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Musculoskeletal pain 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pain in extremity 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Bursitis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Intervertebral disc protrusion 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Lumbar spinal stenosis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Rhabdomyolysis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Arthritis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Periarthritis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Rotator cuff syndrome 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Squamous cell carcinoma 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Bladder transitional cell carcinoma 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Bowen's disease 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Lymphoma 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Laryngeal neoplasm 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Penis carcinoma 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Nervous system disorders
Paralysis 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Headache 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Convulsion 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Transient ischaemic attack 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Dizziness 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Myoclonus 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Post herpetic neuralgia 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Syncope 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Cerebrovascular accident 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Ectopic pregnancy 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Psychiatric disorders
Bipolar disorder 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Depression 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Schizoaffective disorder 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Suicide attempt 1/119 (0.8%) 0/18 (0%) 1/221 (0.5%) 1/54 (1.9%) 2/73 (2.7%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Mental status changes 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Alcoholism 0/119 (0%) 0/18 (0%) 0/221 (0%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Conversion disorder 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Depression suicidal 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Suicidal ideation 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Mood altered 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Renal and urinary disorders
Nephrolithiasis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Urethral disorder 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Urethral stenosis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Renal colic 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Renal failure acute 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Reproductive system and breast disorders
Breast mass 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Fibrocystic breast disease 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Prostatitis 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Breast enlargement 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea 2/119 (1.7%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Asthma 1/119 (0.8%) 0/18 (0%) 4/221 (1.8%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Pleural effusion 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Pneumonitis 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Respiratory failure 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Cough 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Epistaxis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Hypoxia 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pharyngolaryngeal pain 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pneumonia aspiration 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Emphysema 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Lung disorder 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pneumothorax 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Pulmonary embolism 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Chronic obstructive pulmonary disease 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 1/111 (0.9%)
Skin and subcutaneous tissue disorders
Hyperhidrosis 1/119 (0.8%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Skin ulcer 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Rash generalised 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 1/73 (1.4%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Erythema 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Vascular disorders
Hypertension 0/119 (0%) 0/18 (0%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Arteriosclerosis 0/119 (0%) 0/18 (0%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Peripheral arterial occlusive disease 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Peripheral ischaemia 0/119 (0%) 0/18 (0%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Other (Not Including Serious) Adverse Events
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) Final Analysis Population (APV30005)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 115/119 (96.6%) 16/18 (88.9%) 209/221 (94.6%) 53/54 (98.1%) 68/73 (93.2%) 73/78 (93.6%) 76/104 (73.1%) 40/86 (46.5%) 82/111 (73.9%)
Blood and lymphatic system disorders
Lymphadenopathy 9/119 (7.6%) 0/18 (0%) 7/221 (3.2%) 1/54 (1.9%) 0/73 (0%) 4/78 (5.1%) 1/104 (1%) 2/86 (2.3%) 0/111 (0%)
Ear and labyrinth disorders
Vertigo 1/119 (0.8%) 0/18 (0%) 4/221 (1.8%) 0/54 (0%) 3/73 (4.1%) 7/78 (9%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Eye disorders
Conjunctivitis 4/119 (3.4%) 1/18 (5.6%) 14/221 (6.3%) 2/54 (3.7%) 3/73 (4.1%) 7/78 (9%) 2/104 (1.9%) 3/86 (3.5%) 2/111 (1.8%)
Vision blurred 0/119 (0%) 1/18 (5.6%) 5/221 (2.3%) 1/54 (1.9%) 1/73 (1.4%) 3/78 (3.8%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Gastrointestinal disorders
Diarrhoea 51/119 (42.9%) 5/18 (27.8%) 131/221 (59.3%) 15/54 (27.8%) 27/73 (37%) 37/78 (47.4%) 16/104 (15.4%) 14/86 (16.3%) 14/111 (12.6%)
Nausea 47/119 (39.5%) 2/18 (11.1%) 100/221 (45.2%) 8/54 (14.8%) 21/73 (28.8%) 21/78 (26.9%) 9/104 (8.7%) 0/86 (0%) 7/111 (6.3%)
Vomiting 20/119 (16.8%) 2/18 (11.1%) 53/221 (24%) 7/54 (13%) 17/73 (23.3%) 9/78 (11.5%) 4/104 (3.8%) 3/86 (3.5%) 4/111 (3.6%)
Abdominal pain 10/119 (8.4%) 0/18 (0%) 32/221 (14.5%) 3/54 (5.6%) 9/73 (12.3%) 13/78 (16.7%) 1/104 (1%) 5/86 (5.8%) 4/111 (3.6%)
Abdominal pain upper 7/119 (5.9%) 0/18 (0%) 20/221 (9%) 3/54 (5.6%) 7/73 (9.6%) 4/78 (5.1%) 1/104 (1%) 4/86 (4.7%) 3/111 (2.7%)
Dyspepsia 7/119 (5.9%) 1/18 (5.6%) 16/221 (7.2%) 0/54 (0%) 8/73 (11%) 6/78 (7.7%) 5/104 (4.8%) 4/86 (4.7%) 2/111 (1.8%)
Flatulence 6/119 (5%) 0/18 (0%) 18/221 (8.1%) 1/54 (1.9%) 3/73 (4.1%) 7/78 (9%) 0/104 (0%) 2/86 (2.3%) 0/111 (0%)
Aphthous stomatitis 2/119 (1.7%) 1/18 (5.6%) 6/221 (2.7%) 2/54 (3.7%) 1/73 (1.4%) 1/78 (1.3%) 1/104 (1%) 0/86 (0%) 2/111 (1.8%)
Constipation 2/119 (1.7%) 1/18 (5.6%) 8/221 (3.6%) 3/54 (5.6%) 4/73 (5.5%) 4/78 (5.1%) 2/104 (1.9%) 4/86 (4.7%) 2/111 (1.8%)
Gastritis 5/119 (4.2%) 1/18 (5.6%) 2/221 (0.9%) 1/54 (1.9%) 3/73 (4.1%) 1/78 (1.3%) 2/104 (1.9%) 1/86 (1.2%) 4/111 (3.6%)
Pelvic inflammatory disease 4/119 (3.4%) 1/18 (5.6%) 3/221 (1.4%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Proctalgia 0/119 (0%) 1/18 (5.6%) 2/221 (0.9%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Abdominal distension 4/119 (3.4%) 0/18 (0%) 18/221 (8.1%) 1/54 (1.9%) 2/73 (2.7%) 3/78 (3.8%) 2/104 (1.9%) 2/86 (2.3%) 3/111 (2.7%)
Hemorrhoids 3/119 (2.5%) 0/18 (0%) 12/221 (5.4%) 3/54 (5.6%) 5/73 (6.8%) 5/78 (6.4%) 2/104 (1.9%) 0/86 (0%) 3/111 (2.7%)
Dry mouth 2/119 (1.7%) 0/18 (0%) 5/221 (2.3%) 0/54 (0%) 5/73 (6.8%) 3/78 (3.8%) 1/104 (1%) 2/86 (2.3%) 0/111 (0%)
Gastrooesophageal reflux disease 2/119 (1.7%) 0/18 (0%) 6/221 (2.7%) 0/54 (0%) 3/73 (4.1%) 5/78 (6.4%) 5/104 (4.8%) 0/86 (0%) 1/111 (0.9%)
General disorders
Fatigue 22/119 (18.5%) 1/18 (5.6%) 54/221 (24.4%) 4/54 (7.4%) 18/73 (24.7%) 17/78 (21.8%) 6/104 (5.8%) 4/86 (4.7%) 3/111 (2.7%)
Pyrexia 19/119 (16%) 0/18 (0%) 30/221 (13.6%) 3/54 (5.6%) 8/73 (11%) 6/78 (7.7%) 6/104 (5.8%) 8/86 (9.3%) 1/111 (0.9%)
Asthenia 8/119 (6.7%) 1/18 (5.6%) 11/221 (5%) 1/54 (1.9%) 3/73 (4.1%) 7/78 (9%) 3/104 (2.9%) 2/86 (2.3%) 0/111 (0%)
Oedema peripheral 8/119 (6.7%) 0/18 (0%) 10/221 (4.5%) 2/54 (3.7%) 1/73 (1.4%) 3/78 (3.8%) 1/104 (1%) 0/86 (0%) 1/111 (0.9%)
Chest discomfort 6/119 (5%) 0/18 (0%) 4/221 (1.8%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Dental caries 0/119 (0%) 2/18 (11.1%) 1/221 (0.5%) 1/54 (1.9%) 1/73 (1.4%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 2/111 (1.8%)
Chest pain 5/119 (4.2%) 0/18 (0%) 19/221 (8.6%) 5/54 (9.3%) 3/73 (4.1%) 5/78 (6.4%) 4/104 (3.8%) 1/86 (1.2%) 3/111 (2.7%)
Influenza like illness 2/119 (1.7%) 0/18 (0%) 6/221 (2.7%) 1/54 (1.9%) 3/73 (4.1%) 5/78 (6.4%) 0/104 (0%) 2/86 (2.3%) 0/111 (0%)
Infections and infestations
Upper respiratory tract infection 42/119 (35.3%) 4/18 (22.2%) 69/221 (31.2%) 30/54 (55.6%) 22/73 (30.1%) 19/78 (24.4%) 21/104 (20.2%) 8/86 (9.3%) 32/111 (28.8%)
Nasopharyngitis 39/119 (32.8%) 10/18 (55.6%) 48/221 (21.7%) 4/54 (7.4%) 12/73 (16.4%) 19/78 (24.4%) 16/104 (15.4%) 14/86 (16.3%) 23/111 (20.7%)
Sinusitis 16/119 (13.4%) 2/18 (11.1%) 23/221 (10.4%) 5/54 (9.3%) 6/73 (8.2%) 11/78 (14.1%) 7/104 (6.7%) 8/86 (9.3%) 2/111 (1.8%)
Bronchitis 15/119 (12.6%) 0/18 (0%) 40/221 (18.1%) 9/54 (16.7%) 13/73 (17.8%) 8/78 (10.3%) 9/104 (8.7%) 10/86 (11.6%) 8/111 (7.2%)
Anogenital warts 13/119 (10.9%) 0/18 (0%) 5/221 (2.3%) 2/54 (3.7%) 9/73 (12.3%) 1/78 (1.3%) 4/104 (3.8%) 3/86 (3.5%) 1/111 (0.9%)
Gastroenteritis 13/119 (10.9%) 2/18 (11.1%) 14/221 (6.3%) 8/54 (14.8%) 7/73 (9.6%) 5/78 (6.4%) 6/104 (5.8%) 3/86 (3.5%) 4/111 (3.6%)
Influenza 13/119 (10.9%) 0/18 (0%) 37/221 (16.7%) 7/54 (13%) 12/73 (16.4%) 8/78 (10.3%) 9/104 (8.7%) 6/86 (7%) 12/111 (10.8%)
Herpes simplex 12/119 (10.1%) 0/18 (0%) 30/221 (13.6%) 4/54 (7.4%) 0/73 (0%) 2/78 (2.6%) 1/104 (1%) 2/86 (2.3%) 4/111 (3.6%)
Pharyngitis 10/119 (8.4%) 2/18 (11.1%) 14/221 (6.3%) 4/54 (7.4%) 7/73 (9.6%) 5/78 (6.4%) 1/104 (1%) 3/86 (3.5%) 5/111 (4.5%)
Urinary tract infection 6/119 (5%) 0/18 (0%) 11/221 (5%) 6/54 (11.1%) 3/73 (4.1%) 1/78 (1.3%) 1/104 (1%) 1/86 (1.2%) 7/111 (6.3%)
Pneumonia 4/119 (3.4%) 2/18 (11.1%) 2/221 (0.9%) 3/54 (5.6%) 3/73 (4.1%) 2/78 (2.6%) 0/104 (0%) 3/86 (3.5%) 2/111 (1.8%)
Vaginal infection 2/119 (1.7%) 2/18 (11.1%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Abscess limb 4/119 (3.4%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Bronchopneumonia 1/119 (0.8%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Burns second degree 0/119 (0%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Cellulitis 4/119 (3.4%) 1/18 (5.6%) 4/221 (1.8%) 2/54 (3.7%) 2/73 (2.7%) 1/78 (1.3%) 2/104 (1.9%) 0/86 (0%) 0/111 (0%)
Folliculitis 5/119 (4.2%) 1/18 (5.6%) 14/221 (6.3%) 4/54 (7.4%) 1/73 (1.4%) 0/78 (0%) 3/104 (2.9%) 3/86 (3.5%) 1/111 (0.9%)
Parasitic infection intestinal 0/119 (0%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Vaginal candidiasis 0/119 (0%) 1/18 (5.6%) 6/221 (2.7%) 1/54 (1.9%) 0/73 (0%) 0/78 (0%) 1/104 (1%) 0/86 (0%) 0/111 (0%)
Vulvovaginitis trichomonal 2/119 (1.7%) 1/18 (5.6%) 1/221 (0.5%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Sexual transmission of infection 0/119 (0%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 1/111 (0.9%)
Viral upper respiratory tract infection 0/119 (0%) 0/18 (0%) 14/221 (6.3%) 5/54 (9.3%) 2/73 (2.7%) 0/78 (0%) 2/104 (1.9%) 0/86 (0%) 2/111 (1.8%)
Respiratory tract infection 0/119 (0%) 0/18 (0%) 7/221 (3.2%) 4/54 (7.4%) 7/73 (9.6%) 5/78 (6.4%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Ear infection 2/119 (1.7%) 0/18 (0%) 0/221 (0%) 3/54 (5.6%) 3/73 (4.1%) 1/78 (1.3%) 1/104 (1%) 1/86 (1.2%) 0/111 (0%)
Syphilis 5/119 (4.2%) 0/18 (0%) 5/221 (2.3%) 3/54 (5.6%) 1/73 (1.4%) 1/78 (1.3%) 4/104 (3.8%) 2/86 (2.3%) 0/111 (0%)
Tonsillitis 5/119 (4.2%) 0/18 (0%) 6/221 (2.7%) 3/54 (5.6%) 0/73 (0%) 1/78 (1.3%) 1/104 (1%) 0/86 (0%) 1/111 (0.9%)
Viral infection 1/119 (0.8%) 0/18 (0%) 7/221 (3.2%) 3/54 (5.6%) 1/73 (1.4%) 1/78 (1.3%) 4/104 (3.8%) 0/86 (0%) 0/111 (0%)
Tinea pedis 5/119 (4.2%) 0/18 (0%) 9/221 (4.1%) 2/54 (3.7%) 0/73 (0%) 2/78 (2.6%) 6/104 (5.8%) 0/86 (0%) 3/111 (2.7%)
Respiratory tract infection viral 0/119 (0%) 0/18 (0%) 4/221 (1.8%) 2/54 (3.7%) 4/73 (5.5%) 3/78 (3.8%) 3/104 (2.9%) 0/86 (0%) 10/111 (9%)
Rhinitis 2/119 (1.7%) 0/18 (0%) 7/221 (3.2%) 2/54 (3.7%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 3/86 (3.5%) 7/111 (6.3%)
Injury, poisoning and procedural complications
Excoriation 1/119 (0.8%) 1/18 (5.6%) 2/221 (0.9%) 2/54 (3.7%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Investigations
Weight decreased 5/119 (4.2%) 1/18 (5.6%) 18/221 (8.1%) 7/54 (13%) 3/73 (4.1%) 6/78 (7.7%) 4/104 (3.8%) 1/86 (1.2%) 7/111 (6.3%)
Blood triglycerides increased 2/119 (1.7%) 0/18 (0%) 17/221 (7.7%) 1/54 (1.9%) 3/73 (4.1%) 3/78 (3.8%) 2/104 (1.9%) 2/86 (2.3%) 0/111 (0%)
Lipase increased 3/119 (2.5%) 0/18 (0%) 13/221 (5.9%) 0/54 (0%) 6/73 (8.2%) 2/78 (2.6%) 0/104 (0%) 3/86 (3.5%) 0/111 (0%)
Alanine aminotransferase increased 4/119 (3.4%) 0/18 (0%) 10/221 (4.5%) 4/54 (7.4%) 4/73 (5.5%) 2/78 (2.6%) 0/104 (0%) 4/86 (4.7%) 0/111 (0%)
Metabolism and nutrition disorders
Anorexia 5/119 (4.2%) 0/18 (0%) 15/221 (6.8%) 1/54 (1.9%) 0/73 (0%) 5/78 (6.4%) 1/104 (1%) 1/86 (1.2%) 0/111 (0%)
Hypertriglyceridaemia 0/119 (0%) 0/18 (0%) 13/221 (5.9%) 0/54 (0%) 2/73 (2.7%) 7/78 (9%) 2/104 (1.9%) 1/86 (1.2%) 2/111 (1.8%)
Musculoskeletal and connective tissue disorders
Arthralgia 14/119 (11.8%) 0/18 (0%) 29/221 (13.1%) 7/54 (13%) 11/73 (15.1%) 11/78 (14.1%) 5/104 (4.8%) 2/86 (2.3%) 9/111 (8.1%)
Pain in extremity 14/119 (11.8%) 0/18 (0%) 17/221 (7.7%) 5/54 (9.3%) 10/73 (13.7%) 7/78 (9%) 5/104 (4.8%) 3/86 (3.5%) 7/111 (6.3%)
Back pain 11/119 (9.2%) 2/18 (11.1%) 37/221 (16.7%) 8/54 (14.8%) 14/73 (19.2%) 17/78 (21.8%) 9/104 (8.7%) 9/86 (10.5%) 7/111 (6.3%)
Muscle spasms 6/119 (5%) 1/18 (5.6%) 8/221 (3.6%) 0/54 (0%) 7/73 (9.6%) 3/78 (3.8%) 1/104 (1%) 0/86 (0%) 3/111 (2.7%)
Joint sprain 2/119 (1.7%) 1/18 (5.6%) 4/221 (1.8%) 1/54 (1.9%) 2/73 (2.7%) 0/78 (0%) 2/104 (1.9%) 0/86 (0%) 1/111 (0.9%)
Torticollis 1/119 (0.8%) 1/18 (5.6%) 0/221 (0%) 0/54 (0%) 0/73 (0%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Myalgia 4/119 (3.4%) 0/18 (0%) 13/221 (5.9%) 2/54 (3.7%) 9/73 (12.3%) 4/78 (5.1%) 2/104 (1.9%) 4/86 (4.7%) 12/111 (10.8%)
Musculoskeletal pain 2/119 (1.7%) 0/18 (0%) 12/221 (5.4%) 3/54 (5.6%) 3/73 (4.1%) 5/78 (6.4%) 1/104 (1%) 1/86 (1.2%) 2/111 (1.8%)
Nervous system disorders
Headache 34/119 (28.6%) 3/18 (16.7%) 59/221 (26.7%) 3/54 (5.6%) 14/73 (19.2%) 28/78 (35.9%) 10/104 (9.6%) 6/86 (7%) 9/111 (8.1%)
Dizziness 13/119 (10.9%) 2/18 (11.1%) 25/221 (11.3%) 0/54 (0%) 3/73 (4.1%) 9/78 (11.5%) 1/104 (1%) 4/86 (4.7%) 1/111 (0.9%)
Paraesthesia 6/119 (5%) 1/18 (5.6%) 10/221 (4.5%) 0/54 (0%) 8/73 (11%) 6/78 (7.7%) 0/104 (0%) 2/86 (2.3%) 1/111 (0.9%)
Paraesthesia oral 1/119 (0.8%) 0/18 (0%) 19/221 (8.6%) 0/54 (0%) 7/73 (9.6%) 0/78 (0%) 0/104 (0%) 1/86 (1.2%) 0/111 (0%)
Hypoasthesia 3/119 (2.5%) 0/18 (0%) 14/221 (6.3%) 3/54 (5.6%) 3/73 (4.1%) 5/78 (6.4%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Psychiatric disorders
Depression 18/119 (15.1%) 0/18 (0%) 30/221 (13.6%) 6/54 (11.1%) 13/73 (17.8%) 18/78 (23.1%) 10/104 (9.6%) 9/86 (10.5%) 6/111 (5.4%)
Insomnia 15/119 (12.6%) 0/18 (0%) 32/221 (14.5%) 5/54 (9.3%) 13/73 (17.8%) 15/78 (19.2%) 9/104 (8.7%) 4/86 (4.7%) 4/111 (3.6%)
Anxiety 8/119 (6.7%) 0/18 (0%) 21/221 (9.5%) 3/54 (5.6%) 11/73 (15.1%) 12/78 (15.4%) 4/104 (3.8%) 2/86 (2.3%) 2/111 (1.8%)
Reproductive system and breast disorders
Erectile dysfunction 3/119 (2.5%) 0/18 (0%) 9/221 (4.1%) 1/54 (1.9%) 6/73 (8.2%) 6/78 (7.7%) 2/104 (1.9%) 2/86 (2.3%) 0/111 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 24/119 (20.2%) 0/18 (0%) 56/221 (25.3%) 13/54 (24.1%) 13/73 (17.8%) 13/78 (16.7%) 5/104 (4.8%) 6/86 (7%) 10/111 (9%)
Pharyngolaryngeal pain 14/119 (11.8%) 1/18 (5.6%) 18/221 (8.1%) 0/54 (0%) 5/73 (6.8%) 9/78 (11.5%) 3/104 (2.9%) 6/86 (7%) 0/111 (0%)
Rhinitis allergic 8/119 (6.7%) 0/18 (0%) 12/221 (5.4%) 6/54 (11.1%) 2/73 (2.7%) 2/78 (2.6%) 2/104 (1.9%) 2/86 (2.3%) 9/111 (8.1%)
Rhinorrhoea 7/119 (5.9%) 0/18 (0%) 2/221 (0.9%) 2/54 (3.7%) 1/73 (1.4%) 1/78 (1.3%) 1/104 (1%) 1/86 (1.2%) 0/111 (0%)
Nasal congestion 4/119 (3.4%) 1/18 (5.6%) 16/221 (7.2%) 1/54 (1.9%) 3/73 (4.1%) 5/78 (6.4%) 0/104 (0%) 3/86 (3.5%) 0/111 (0%)
Sinus congestion 5/119 (4.2%) 0/18 (0%) 13/221 (5.9%) 1/54 (1.9%) 3/73 (4.1%) 1/78 (1.3%) 5/104 (4.8%) 0/86 (0%) 0/111 (0%)
Seasonal allergy 5/119 (4.2%) 0/18 (0%) 12/221 (5.4%) 0/54 (0%) 2/73 (2.7%) 1/78 (1.3%) 2/104 (1.9%) 0/86 (0%) 2/111 (1.8%)
Skin and subcutaneous tissue disorders
Rash 35/119 (29.4%) 2/18 (11.1%) 41/221 (18.6%) 7/54 (13%) 8/73 (11%) 12/78 (15.4%) 4/104 (3.8%) 1/86 (1.2%) 7/111 (6.3%)
Pruritus 10/119 (8.4%) 1/18 (5.6%) 18/221 (8.1%) 4/54 (7.4%) 11/73 (15.1%) 7/78 (9%) 1/104 (1%) 1/86 (1.2%) 0/111 (0%)
Dry skin 7/119 (5.9%) 0/18 (0%) 9/221 (4.1%) 1/54 (1.9%) 3/73 (4.1%) 2/78 (2.6%) 6/104 (5.8%) 0/86 (0%) 1/111 (0.9%)
Lipodystrophy acquired 7/119 (5.9%) 0/18 (0%) 9/221 (4.1%) 0/54 (0%) 2/73 (2.7%) 1/78 (1.3%) 2/104 (1.9%) 3/86 (3.5%) 1/111 (0.9%)
Night sweats 7/119 (5.9%) 0/18 (0%) 11/221 (5%) 1/54 (1.9%) 4/73 (5.5%) 4/78 (5.1%) 1/104 (1%) 2/86 (2.3%) 0/111 (0%)
Dermititis 6/119 (5%) 0/18 (0%) 6/221 (2.7%) 0/54 (0%) 2/73 (2.7%) 0/78 (0%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Eczema 5/119 (4.2%) 1/18 (5.6%) 5/221 (2.3%) 2/54 (3.7%) 1/73 (1.4%) 3/78 (3.8%) 0/104 (0%) 0/86 (0%) 0/111 (0%)
Skin papilloma 0/119 (0%) 0/18 (0%) 5/221 (2.3%) 1/54 (1.9%) 10/73 (13.7%) 4/78 (5.1%) 1/104 (1%) 2/86 (2.3%) 1/111 (0.9%)
Vascular disorders
Hypertension 8/119 (6.7%) 0/18 (0%) 20/221 (9%) 1/54 (1.9%) 3/73 (4.1%) 5/78 (6.4%) 5/104 (4.8%) 1/86 (1.2%) 11/111 (9.9%)
Hot flush 0/119 (0%) 1/18 (5.6%) 4/221 (1.8%) 0/54 (0%) 0/73 (0%) 1/78 (1.3%) 2/104 (1.9%) 0/86 (0%) 2/111 (1.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization ViiV Healthcare
Phone 866-435-7343
Email
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00296504
Other Study ID Numbers:
  • APV30005
First Posted:
Feb 27, 2006
Last Update Posted:
Apr 19, 2013
Last Verified:
Jun 1, 2012