Trial Outcomes & Findings for Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study) (NCT NCT00013611)

NCT ID: NCT00013611

Last Updated: 2011-08-08

Results Overview

Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause. AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (\> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1695 participants
• Primary outcome timeframe: From randomization to date last known to be alive or November 15, 2008, whichever is earlier
• Results posted on: 2011-08-08

Participant Flow

1971 participants were randomized at 139 sites in 11 countries. The first randomization was on 30 April 1999 and the last randomization was on 28 September 2002. Sites who re-consented 2/3 or more of their participants to Version 3 of the protocol were included in the analysis cohort. There are 1695 participants in the analysis cohort.

Participant milestones

Measure	Antiretroviral Therapy Only All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.	Proleukin Plus Antiretroviral Therapy Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
Overall Study STARTED	846	849
Overall Study COMPLETED	746	758
Overall Study NOT COMPLETED	100	91

Reasons for withdrawal

Measure	Antiretroviral Therapy Only All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.	Proleukin Plus Antiretroviral Therapy Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
Overall Study Lost to Follow-up	100	91

Baseline Characteristics

Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)

Baseline characteristics by cohort

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants	Total n=1695 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	841 Participants n=5 Participants	838 Participants n=7 Participants	1679 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age Continuous	41.8 years STANDARD_DEVIATION 8.7 • n=5 Participants	42.0 years STANDARD_DEVIATION 8.8 • n=7 Participants	41.9 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	143 Participants n=7 Participants	280 Participants n=5 Participants
Sex: Female, Male Male	712 Participants n=5 Participants	703 Participants n=7 Participants	1415 Participants n=5 Participants
Region of Enrollment Belgium	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Germany	50 participants n=5 Participants	46 participants n=7 Participants	96 participants n=5 Participants
Region of Enrollment Spain	139 participants n=5 Participants	131 participants n=7 Participants	270 participants n=5 Participants
Region of Enrollment France	47 participants n=5 Participants	50 participants n=7 Participants	97 participants n=5 Participants
Region of Enrollment Italy	131 participants n=5 Participants	142 participants n=7 Participants	273 participants n=5 Participants
Region of Enrollment Netherlands	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Argentina	85 participants n=5 Participants	85 participants n=7 Participants	170 participants n=5 Participants
Region of Enrollment Australia	62 participants n=5 Participants	64 participants n=7 Participants	126 participants n=5 Participants
Region of Enrollment United States	203 participants n=5 Participants	203 participants n=7 Participants	406 participants n=5 Participants
Region of Enrollment Canada	68 participants n=5 Participants	62 participants n=7 Participants	130 participants n=5 Participants
Region of Enrollment Brazil	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to date last known to be alive or November 15, 2008, whichever is earlier

Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause.

AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease.

Outcome measures

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants
New or Recurrent Disease Progression Events, as Defined, or Death.	110 Participants	119 Participants

SECONDARY outcome

Timeframe: From randomization to date last known to be alive or November 15, 2008, whichever is earlier

Number of participants who died.

Outcome measures

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants
All-cause Mortality	81 Participants	77 Participants

SECONDARY outcome

Timeframe: From randomization to date last known to be alive or November 15, 2008, whichever is earlier

Number of participants with fatal or non-fatal AIDS-related opportunistic disease.

AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease.

Outcome measures

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants
New or Recurrent Disease Progression Events	49 Participants	66 Participants

SECONDARY outcome

Timeframe: From randomization to date last known to be alive or November 15, 2008, whichever is earlier

Population: The outcome is the number of participants experiencing at least one grade 4 event.

Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.

Outcome measures

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants
Grade 4 Clinical Events	203 Participants	186 Participants

SECONDARY outcome

Timeframe: Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest .

Mean CD4+ cell count (cells per cubic mm) averaged over follow-up

Outcome measures

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants
CD4+ Cell Count	345.1 cells per cubic mm Standard Error 5.1	292.1 cells per cubic mm Standard Error 4.1

SECONDARY outcome

Timeframe: From randomization to date last known to be alive or November 15, 2008, whichever is earlier

Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease.

A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease.

Outcome measures

Measure	Proleukin Plus Antiretroviral Therapy n=849 Participants	Antiretroviral Therapy Only n=846 Participants
New or Recurrent Serious Disease Progression Events or Death	19 Participants	28 Participants

Adverse Events

Proleukin Plus Antiretroviral Therapy

Serious events: 203 serious events

Other events: 0 other events

Deaths: 0 deaths

Antiretroviral Therapy Only

Serious events: 186 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Proleukin Plus Antiretroviral Therapy n=849 participants at risk	Antiretroviral Therapy Only n=846 participants at risk
Blood and lymphatic system disorders Aneamias nonhaemolytic and marrow depression	0.35% 3/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.71% 6/846 • Number of events 6 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Blood and lymphatic system disorders Haemolyses and related conditions	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Blood and lymphatic system disorders Platelet disorders	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Blood and lymphatic system disorders Spleen, lymphatic and reticuloendothelial system disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Blood and lymphatic system disorders White blood cell disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Cardiac arrythmias	0.47% 4/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Cardiac disorder signs and symptoms	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Cornoary artery disorders	2.4% 20/849 • Number of events 29 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	2.4% 20/846 • Number of events 24 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Heart failures	0.35% 3/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.71% 6/846 • Number of events 13 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Myocardial disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Pericardial disorders	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Cardiac disorders Cardiac valve disorders	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Congenital, familial and genetic disorders Renal and urinary tract disoerders congenital	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Endocrine disorders Endocrine disorders of gonadal function	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Endocrine disorders Thyroid gland disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Eye disorders Ocular neuromuscular disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Abdominal hernias and other adominal wall conditions	0.59% 5/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Diverticular disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Exocrine pancreas conditions	0.71% 6/849 • Number of events 13 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.71% 6/846 • Number of events 7 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal condictions NEC	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal haemorrhages NEC	1.5% 13/849 • Number of events 15 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.59% 5/846 • Number of events 10 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal inflammatory conditions	0.47% 4/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal motility and defaecation conditions	0.71% 6/849 • Number of events 8 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.59% 5/846 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal stenosis and obstructions	0.59% 5/849 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal signs and symptoms	0.47% 4/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal ulceration and perforation	0.59% 5/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Gastrointestinal vascular conditions	0.82% 7/849 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Gastrointestinal disorders Peritoneal and retrooperationael conditions	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
General disorders Body temperature conditions	0.35% 3/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
General disorders General system disorders NEC	0.71% 6/849 • Number of events 6 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
General disorders Fatal outcomes	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
General disorders Therapeutic and nontherapeutic effects (excl toxicity)	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Hepatobiliary disorders Bile duct disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Hepatobiliary disorders Gallbladder disorders	0.47% 4/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.83% 7/846 • Number of events 7 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Hepatobiliary disorders Hepatic and hepatobiliary disorders	2.4% 20/849 • Number of events 26 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	1.2% 10/846 • Number of events 14 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Immune system disorders Allergic conditions	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Immune system disorders Immune disorders NEC	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Infections and infestations Bacterial infectious disorders	1.6% 14/849 • Number of events 19 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	2.1% 18/846 • Number of events 20 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Infections and infestations Fungal infectious disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Infections and infestations Infections - pathogen unspecified	3.3% 28/849 • Number of events 31 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	3.2% 27/846 • Number of events 30 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Infections and infestations Mycobacterial infectious disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Infections and infestations Viral infectious disorders	1.3% 11/849 • Number of events 11 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	1.3% 11/846 • Number of events 16 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Injury, poisoning and procedural complications Bone and joint injuries	0.71% 6/849 • Number of events 6 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Injury, poisoning and procedural complications Injuries NEC	0.24% 2/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.59% 5/846 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Injury, poisoning and procedural complications Procedural and device related injuries and complications NEC	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.59% 5/846 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Injury, poisoning and procedural complications Medications errors	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Injury, poisoning and procedural complications Chemical injury and poisoning	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Investigations Gastrointestinal investigations	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Investigations Hepatobiliary investigations	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Investigations Lipid analyses	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Investigations Metabolic, nutritional and blood gas investigations	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Metabolism and nutrition disorders Acid-base disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Metabolism and nutrition disorders Appetite and general nutritional disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Metabolism and nutrition disorders Electrolyte and fluid balance conditions	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Metabolism and nutrition disorders Glucose metabolism disorders (incl diabetes mellitus)	0.47% 4/849 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Metabolism and nutrition disorders Purine and pyrimidine metabolism disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Musculoskeletal and connective tissue disorders Bone disorders (excl congenital and fractuers)	0.71% 6/849 • Number of events 7 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Musculoskeletal and connective tissue disorders Joint disorders	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.71% 6/846 • Number of events 8 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders NEC	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endocrine neoplasms malignant and unspecified	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasms malignant and unspecified	0.82% 7/849 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	1.2% 10/846 • Number of events 11 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic and biliary neoplasms benign	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatobiliary neoplasms malignant and unspecified	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemias	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesotheliomas	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Miscellaneuous and site unspecified neoplasms malignant and unspecified	0.59% 5/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Miscellaneous and site unspecified neoplasms benign	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system neoplasms malignant and unspecified NEC	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal and urinary tract neoplasms malignant and unspecified	0.35% 3/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Reproductive neoplasms female malignant and unspecified	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Reproductive neoplasms male malignant and unspecified	0.59% 5/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Respiratory and mediastinal neoplams malignant and unspecified	1.4% 12/849 • Number of events 14 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	1.3% 11/846 • Number of events 13 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin neoplasms malignant and unspecified	0.82% 7/849 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complications and emergencies	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Central nervous system vascular disorders	1.1% 9/849 • Number of events 9 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.95% 8/846 • Number of events 10 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Cranial nerve disorders (excl neoplasms)	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Encephalopathies	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Headaches	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Movement disorders (incl parkinsonism)	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Neurological disorders NEC	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Neuromuscular disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Seizures (incl subtypes)	0.35% 3/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Spinal cord and nreve root disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Nervous system disorders Structural brain disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Anxiety disorders and symptoms	0.35% 3/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Cognitive and attention disorders and distrubances	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Deliria (incl confusion)	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Depressed mood disorders and disturbances	0.82% 7/849 • Number of events 8 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Manic and bipolar mood disorders and disturbances	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Personality disorders and disturbances in behaviour	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Psychiatric disorders NEC	0.47% 4/849 • Number of events 5 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Schizophrenia and other psychotic disorders	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Psychiatric disorders Suicidal and self-injurious behaviours NEC	1.2% 10/849 • Number of events 11 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Renal and urinary disorders Nephropathies	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Renal and urinary disorders Renal disorders (excl nephropathies)	0.59% 5/849 • Number of events 6 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	1.4% 12/846 • Number of events 13 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Renal and urinary disorders Urinary tract signs and symptoms	0.24% 2/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Renal and urinary disorders Urolithiases	0.47% 4/849 • Number of events 6 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Reproductive system and breast disorders Breast disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Reproductive system and breast disorders Cervix disorders (excl infections and inflammations)	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Reproductive system and breast disorders Male reproductive tract infections and inflammations	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Reproductive system and breast disorders Prostatic disorders (excl infections and inflammations)	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Reproductive system and breast disorders Uterine, pelvic and broad ligament disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Reproductive system and breast disorders Vulvovaginal disorders (excl infections and inflammations)	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Bronchial disorders (excl neoplasms)	0.24% 2/849 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.47% 4/846 • Number of events 6 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Thoracic disorders (excl lung and pleura)	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract disorders (excl obstruction and infection)	0.35% 3/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Pleural disorders	0.24% 2/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Pulmonary vascular disorders	0.35% 3/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Respiratory disorders NEC	0.47% 4/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	1.3% 11/846 • Number of events 12 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract disorders (excl infections)	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Skin and subcutaneous tissue disorders Epidermal and dermal conditions	0.35% 3/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Skin and subcutaneous tissue disorders Skin and subcutaenous tissue disorders NEC	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Surgical and medical procedures Vascular therapeutic procedures	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Surgical and medical procedures Nervous system, skull and spine therapeutic procedures	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Surgical and medical procedures Hepatobiliary therapeutic procedures	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.12% 1/846 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Aneurysms and artery dissections	0.24% 2/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Arteriosclerosis, stenosis, vascular insufficiency and necrosis	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Decreased and nonspecific blood pressure disorders and shock	0.35% 3/849 • Number of events 3 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.35% 3/846 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Embolism and thrombosis	0.47% 4/849 • Number of events 4 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Vascular disorders NEC	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Vascular haemorrhagic disorders	0.12% 1/849 • Number of events 1 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.00% 0/846 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.
Vascular disorders Vascular hypertensive disorders	0.00% 0/849 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.	0.24% 2/846 • Number of events 2 • From randomization to date last known to be alive or November 15, 2008, whichever is earlier Adverse events are defined as Grade 4 events not due to progression of HIV disease. Serious and/or other \[non-serious) adverse events were not collected/assessed. Other Adverse Events were not collected.

Other adverse events

Adverse event data not reported

Additional Information

Gary Collins, M.S.

University of Minnesota

Phone: 612-626-9006

Email: gary-c@ccbr.umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place