Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019) (NCT NCT00293254)

NCT ID: NCT00293254

Last Updated: 2017-03-21

Results Overview

Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 16

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

351 participants

Primary outcome timeframe

16 Weeks

Results posted on

2017-03-21

Participant Flow

Phase 3; First Patient In: 08-Mar-2006; Last Patient Last Visit (LPLV) for Week 48: 31-Jul-2007; Extension Study LPLV Week 240: May 2011 53 sites (US, Brazil, Canada, Colombia, Mexico, and Puerto Rico).

Patients failed prior antiretroviral therapy (HIV RNA \>1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitors, and Protease Inhibitors). All patients must have met laboratory criteria.

Participant milestones

Participant milestones
Measure	Raltegravir 400 mg b.i.d. + OBT	Placebo + OBT
Primary Study - Double-Blind Week 0-48 STARTED	232	119
Primary Study - Double-Blind Week 0-48 Treated	230	119
Primary Study - Double-Blind Week 0-48 Continuing in Double-Blind	177	55
Primary Study - Double-Blind Week 0-48 COMPLETED	177	55
Primary Study - Double-Blind Week 0-48 NOT COMPLETED	55	64
Extension - Double-Blind Week 49-156 STARTED	177	54
Extension - Double-Blind Week 49-156 COMPLETED	120	25
Extension - Double-Blind Week 49-156 NOT COMPLETED	57	29
Extension - Open-Label Week 157-240 STARTED	120	19
Extension - Open-Label Week 157-240 COMPLETED	110	18
Extension - Open-Label Week 157-240 NOT COMPLETED	10	1
Open-Label Post Virologic Failure Phase STARTED	50	64
Open-Label Post Virologic Failure Phase COMPLETED	19	37
Open-Label Post Virologic Failure Phase NOT COMPLETED	31	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Raltegravir 400 mg b.i.d. + OBT	Placebo + OBT
Primary Study - Double-Blind Week 0-48 Never Treated	2	0
Primary Study - Double-Blind Week 0-48 Adverse Event	2	1
Primary Study - Double-Blind Week 0-48 Death	5	2
Primary Study - Double-Blind Week 0-48 Lack of Efficacy	2	2
Primary Study - Double-Blind Week 0-48 Lost to Follow-up	3	1
Primary Study - Double-Blind Week 0-48 Withdrawal by Subject	5	1
Primary Study - Double-Blind Week 0-48 Moved or trial terminated at site	1	0
Primary Study - Double-Blind Week 0-48 Entered OLPVF Phase	35	57
Extension - Double-Blind Week 49-156 Adverse Event	4	1
Extension - Double-Blind Week 49-156 Death	4	1
Extension - Double-Blind Week 49-156 Lack of Efficacy	3	4
Extension - Double-Blind Week 49-156 Lost to Follow-up	3	3
Extension - Double-Blind Week 49-156 Withdrawal by Subject	12	8
Extension - Double-Blind Week 49-156 Participant Moved/Site Stopped Trial	6	3
Extension - Double-Blind Week 49-156 Other Reason	10	2
Extension - Double-Blind Week 49-156 Entered OLPVF Phase	15	7
Extension - Open-Label Week 157-240 Adverse Event	2	1
Extension - Open-Label Week 157-240 Lack of Efficacy	1	0
Extension - Open-Label Week 157-240 Withdrawal by Subject	1	0
Extension - Open-Label Week 157-240 Lost to Follow-up	2	0
Extension - Open-Label Week 157-240 Other Reason	4	0
Open-Label Post Virologic Failure Phase Adverse Event	4	7
Open-Label Post Virologic Failure Phase Lack of Efficacy	16	14
Open-Label Post Virologic Failure Phase Withdrawal by Subject	6	3
Open-Label Post Virologic Failure Phase Lost to Follow-up	3	0
Open-Label Post Virologic Failure Phase Participant Moved/Site Stopped Trial	1	1
Open-Label Post Virologic Failure Phase Other Reason	1	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir 400 mg b.i.d. + OBT n=230 Participants	Placebo + OBT n=119 Participants	Total n=349 Participants Total of all reporting groups
Age, Continuous	45.3 Years n=5 Participants	46.5 Years n=7 Participants	45.7 Years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	210 Participants n=5 Participants	107 Participants n=7 Participants	317 Participants n=5 Participants
Race/Ethnicity, Customized White	127 Participants n=5 Participants	77 Participants n=7 Participants	204 Participants n=5 Participants
Race/Ethnicity, Customized Black	47 Participants n=5 Participants	21 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	47 Participants n=5 Participants	18 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Cluster of Differentiation 4 (CD4) Cell Count	146 cells/mm^3 n=5 Participants	163 cells/mm^3 n=7 Participants	152 cells/mm^3 n=5 Participants
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)	49159 copies/mL n=5 Participants	47850 copies/mL n=7 Participants	48709 copies/mL n=5 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 16

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=229 Participants	Placebo + OBT n=119 Participants
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16	77.3 Percentage of Participants Interval 71.3 to 82.6	42.9 Percentage of Participants Interval 33.8 to 52.3

PRIMARY outcome

Timeframe: 48 Weeks

Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 48

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=228 Participants	Placebo + OBT n=119 Participants
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48	71.1 Percentage of Participants Interval 64.7 to 76.8	37.8 Percentage of Participants Interval 29.1 to 47.2

PRIMARY outcome

Timeframe: 156 Weeks

Population: The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures. Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA \<400 copies/mL at Week 156

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=229 Participants	Placebo + OBT n=119 Participants
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL	50.2 Percentage of Participants Interval 43.6 to 56.9	21.0 Percentage of Participants Interval 14.1 to 29.4

PRIMARY outcome

Timeframe: 240 Weeks

Percentage of participants who achieved HIV RNA \<400 Copies/mL at Week 240

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=230 Participants	Placebo + OBT n=119 Participants
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL	45.7 Percentage of Participants Interval 39.1 to 52.3	13.4 Percentage of Participants Interval 7.9 to 20.9

SECONDARY outcome

Timeframe: 16 Weeks

Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 16

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=229 Participants	Placebo + OBT n=119 Participants
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16	62.0 Percentage of Participants Interval 55.4 to 68.3	36.1 Percentage of Participants Interval 27.5 to 45.4

SECONDARY outcome

Timeframe: 48 Weeks

Population: Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 48

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=228 Participants	Placebo + OBT n=119 Participants
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48	59.6 Percentage of Participants Interval 53.0 to 66.1	34.5 Percentage of Participants Interval 26.0 to 43.7

SECONDARY outcome

Timeframe: 156 Weeks

Population: Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 156

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=229 Participants	Placebo + OBT n=119 Participants
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL	47.6 Percentage of Participants Interval 41.0 to 54.3	17.6 Percentage of Participants Interval 11.3 to 25.7

SECONDARY outcome

Timeframe: 240 Weeks

Population: Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA \<50 copies/mL at Week 240

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=230 Participants	Placebo + OBT n=119 Participants
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL	41.3 Percentage of Participants Interval 34.9 to 48.0	13.4 Percentage of Participants Interval 7.9 to 20.9

SECONDARY outcome

Timeframe: 156 Weeks

Population: Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

For participants with confirmed HIV RNA levels \<50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value \>50 copies/mL or loss to follow-up; participants who never achieved HIV RNA \<50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=230 Participants	Placebo + OBT n=119 Participants
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response	44.3 Percentage of Participants	17.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace \<400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=222 Participants	Placebo + OBT n=117 Participants
Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16	-1.92 HIV RNA (log10 copies/mL) Interval -2.05 to -1.78	-1.06 HIV RNA (log10 copies/mL) Interval -1.26 to -0.86

SECONDARY outcome

Timeframe: Baseline and Week 48

Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=216 Participants	Placebo + OBT n=114 Participants
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48	-1.75 HIV RNA (log10 copies/mL) Interval -1.9 to -1.59	-0.87 HIV RNA (log10 copies/mL) Interval -1.08 to -0.67

SECONDARY outcome

Timeframe: Baseline and Week 156

Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=189 Participants	Placebo + OBT n=102 Participants
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)	-1.37 HIV RNA (log10 copies/mL) Interval -1.55 to -1.2	-0.52 HIV RNA (log10 copies/mL) Interval -0.71 to -0.33

SECONDARY outcome

Timeframe: Baseline and Week 240

Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=182 Participants	Placebo + OBT n=95 Participants
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)	-1.31 HIV RNA (log10 copies/mL) Interval -1.49 to -1.13	-0.41 HIV RNA (log10 copies/mL) Interval -0.59 to -0.23

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm\^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Mean change from baseline at Week 16 in CD4 cell count (cells/mm\^3)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=219 Participants	Placebo + OBT n=117 Participants
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16	85.8 CD4 Cell Count (cells/mm^3) Interval 72.7 to 99.0	39.9 CD4 Cell Count (cells/mm^3) Interval 26.2 to 53.6

SECONDARY outcome

Timeframe: Baseline and Week 48

Mean change from baseline at Week 48 in CD4 cell count (cells/mm\^3)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=217 Participants	Placebo + OBT n=114 Participants
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48	98.4 CD4 Cell Count (cells/mm^3) Interval 84.1 to 112.7	39.8 CD4 Cell Count (cells/mm^3) Interval 23.5 to 56.1

SECONDARY outcome

Timeframe: Baseline and Week 156

Mean change from baseline at Week 156 in CD4 cell count (cells/mm\^3)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=189 Participants	Placebo + OBT n=101 Participants
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)	157.2 CD4 Cell Count (cells/mm^3) Interval 130.7 to 183.6	54.2 CD4 Cell Count (cells/mm^3) Interval 30.0 to 78.3

SECONDARY outcome

Timeframe: Baseline and Week 240

Mean change from baseline at Week 240 in CD4 cell count (cells/mm\^3)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=181 Participants	Placebo + OBT n=95 Participants
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)	172.1 CD4 Cell Count (Cells/mm^3) Interval 141.7 to 202.5	54.1 CD4 Cell Count (Cells/mm^3) Interval 27.1 to 81.0

Adverse Events

Raltegravir 400 mg b.i.d. Plus OBT

Serious events: 80 serious events

Other events: 214 other events

Deaths: 0 deaths

Placebo Plus OBT

Serious events: 54 serious events

Other events: 111 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial, but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Raltegravir 400 mg b.i.d. Plus OBT n=230 participants at risk Includes all participants initially randomized to raltegravir, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.	Placebo Plus OBT n=119 participants at risk Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
Gastrointestinal disorders Colitis	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Colonic polyp	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Diarrhoea	0.87% 2/230 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Dyspepsia	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Gastric haemorrhage	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.87% 2/230 • Number of events 3 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Ileitis	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Nausea	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Oesophagitis	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Pancreatic mass	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Pancreatitis	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Pancreatitis necrotising	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Peritonitis	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Small intestinal obstruction	0.87% 2/230 • Number of events 3 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Vomiting	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Asthenia	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Death	0.87% 2/230 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	2.5% 3/119 • Number of events 3 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Malaise	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Non-cardiac chest pain	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Pyrexia	2.2% 5/230 • Number of events 5 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	2.5% 3/119 • Number of events 3 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Hepatobiliary disorders Cholecystitis acute	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Immune system disorders Drug hypersensitivity	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Immune system disorders Hypersensitivity	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Immune system disorders Immune reconstitution syndrome	0.87% 2/230 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations AIDS dementia complex	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Abdominal abscess	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Abdominal wall abscess	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Anaemia	2.2% 5/230 • Number of events 6 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Febrile neutropenia	0.43% 1/230 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Neutropenia	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	1.7% 2/119 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Pancytopenia	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/119 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Cardiac disorders Acute coronary syndrome	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Cardiac disorders Angina unstable	0.43% 1/230 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Cardiac disorders Atrial fibrillation	0.87% 2/230 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Cardiac disorders Bradycardia	0.00% 0/230 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.84% 1/119 • Number of events 1 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.

Other adverse events
Measure	Raltegravir 400 mg b.i.d. Plus OBT n=230 participants at risk Includes all participants initially randomized to raltegravir, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.	Placebo Plus OBT n=119 participants at risk Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
Blood and lymphatic system disorders Anaemia	3.9% 9/230 • Number of events 9 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/119 • Number of events 10 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Lymphadenopathy	8.3% 19/230 • Number of events 24 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	3.4% 4/119 • Number of events 4 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Eye disorders Conjunctivitis	7.4% 17/230 • Number of events 18 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	1.7% 2/119 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Abdominal distension	6.5% 15/230 • Number of events 18 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.0% 6/119 • Number of events 6 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Abdominal pain	10.9% 25/230 • Number of events 31 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/119 • Number of events 8 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Abdominal pain upper	7.4% 17/230 • Number of events 19 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.2% 11/119 • Number of events 11 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Constipation	6.5% 15/230 • Number of events 19 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	4.2% 5/119 • Number of events 6 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Diarrhoea	32.6% 75/230 • Number of events 108 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	29.4% 35/119 • Number of events 41 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Dry mouth	0.87% 2/230 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/119 • Number of events 7 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Flatulence	7.4% 17/230 • Number of events 20 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	4.2% 5/119 • Number of events 7 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Haemorrhoids	3.5% 8/230 • Number of events 8 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.0% 6/119 • Number of events 6 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Nausea	17.8% 41/230 • Number of events 57 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	25.2% 30/119 • Number of events 40 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Vomiting	10.9% 25/230 • Number of events 41 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	14.3% 17/119 • Number of events 19 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Asthenia	5.2% 12/230 • Number of events 13 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	1.7% 2/119 • Number of events 2 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Chest pain	5.7% 13/230 • Number of events 15 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	3.4% 4/119 • Number of events 4 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Fatigue	19.6% 45/230 • Number of events 57 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	15.1% 18/119 • Number of events 22 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Injection site reaction	15.2% 35/230 • Number of events 41 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	11.8% 14/119 • Number of events 16 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Oedema peripheral	5.2% 12/230 • Number of events 13 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/119 • Number of events 10 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Pyrexia	12.6% 29/230 • Number of events 32 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	20.2% 24/119 • Number of events 35 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Anogenital warts	5.2% 12/230 • Number of events 15 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	3.4% 4/119 • Number of events 4 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Bronchitis	14.8% 34/230 • Number of events 44 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	12.6% 15/119 • Number of events 18 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Cellulitis	4.8% 11/230 • Number of events 15 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/119 • Number of events 7 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Folliculitis	5.2% 12/230 • Number of events 14 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	3.4% 4/119 • Number of events 4 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Furuncle	1.7% 4/230 • Number of events 4 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.0% 6/119 • Number of events 6 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Gastroenteritis	5.7% 13/230 • Number of events 14 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.0% 6/119 • Number of events 6 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Herpes zoster	11.7% 27/230 • Number of events 30 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	4.2% 5/119 • Number of events 5 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Influenza	7.4% 17/230 • Number of events 21 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/119 • Number of events 14 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Nasopharyngitis	12.6% 29/230 • Number of events 50 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	12.6% 15/119 • Number of events 20 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Onychomycosis	3.5% 8/230 • Number of events 9 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/119 • Number of events 8 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Oral candidiasis	5.2% 12/230 • Number of events 12 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.2% 11/119 • Number of events 12 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pneumonia	6.1% 14/230 • Number of events 19 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	8.4% 10/119 • Number of events 14 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Sinusitis	15.2% 35/230 • Number of events 50 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	12.6% 15/119 • Number of events 18 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Upper respiratory tract infection	33.0% 76/230 • Number of events 114 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	24.4% 29/119 • Number of events 47 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Urinary tract infection	4.8% 11/230 • Number of events 12 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.2% 11/119 • Number of events 18 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Alanine aminotransferase increased	7.8% 18/230 • Number of events 29 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/119 • Number of events 11 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Aspartate aminotransferase increased	8.7% 20/230 • Number of events 27 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/119 • Number of events 12 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood bilirubin increased	2.6% 6/230 • Number of events 7 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.0% 6/119 • Number of events 10 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood cholesterol increased	4.3% 10/230 • Number of events 11 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/119 • Number of events 11 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood creatine phosphokinase increased	9.1% 21/230 • Number of events 24 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	6.7% 8/119 • Number of events 8 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood creatinine increased	7.8% 18/230 • Number of events 37 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.2% 11/119 • Number of events 17 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.