Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2) (NCT NCT00293267)

NCT ID: NCT00293267

Last Updated: 2015-09-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

352 participants

Primary outcome timeframe

16 Weeks

Results posted on

2015-09-07

Participant Flow

Phase 3; First Patient In: Mar 2006; Last Patient Last Visit (LPLV) Week 48: Aug 2007; 61 of 63 sites in Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, Thailand randomized patients. Extension Study LPLV Week 240: June 2011

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	234	118
Primary Study - Double-Blind Week 0-48 Treated	232	118
Primary Study - Double-Blind Week 0-48 Continuing in Double-Blind	193	50
Primary Study - Double-Blind Week 0-48 COMPLETED	193	50
Primary Study - Double-Blind Week 0-48 NOT COMPLETED	41	68
Extension - Double-Blind Week 49-156 STARTED	191	50
Extension - Double-Blind Week 49-156 COMPLETED	139	35
Extension - Double-Blind Week 49-156 NOT COMPLETED	52	15
Extension - Open-Label Week 157-240 STARTED	131	28
Extension - Open-Label Week 157-240 COMPLETED	111	26
Extension - Open-Label Week 157-240 NOT COMPLETED	20	2
Open-Label Post Virologic Failure Phase STARTED	48	66
Open-Label Post Virologic Failure Phase COMPLETED	15	29
Open-Label Post Virologic Failure Phase NOT COMPLETED	33	37

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	1	1
Primary Study - Double-Blind Week 0-48 Death	3	3
Primary Study - Double-Blind Week 0-48 Lack of Efficacy	0	2
Primary Study - Double-Blind Week 0-48 Lost to Follow-up	1	1
Primary Study - Double-Blind Week 0-48 Withdrawal by Subject	1	1
Primary Study - Double-Blind Week 0-48 Entered OLPVF Phase	33	60
Extension - Double-Blind Week 49-156 Adverse Event	1	4
Extension - Double-Blind Week 49-156 Lack of Efficacy	7	1
Extension - Double-Blind Week 49-156 Lost to Follow-up	4	0
Extension - Double-Blind Week 49-156 Withdrawal by Subject	13	4
Extension - Double-Blind Week 49-156 Death	3	0
Extension - Double-Blind Week 49-156 Participant relocated or site terminated	2	0
Extension - Double-Blind Week 49-156 Other Reason	7	0
Extension - Double-Blind Week 49-156 Entered OLPVF Phase	15	6
Extension - Open-Label Week 157-240 Adverse Event	5	0
Extension - Open-Label Week 157-240 Lack of Efficacy	7	0
Extension - Open-Label Week 157-240 Lost to Follow-up	1	0
Extension - Open-Label Week 157-240 Withdrawal by Subject	2	1
Extension - Open-Label Week 157-240 Participant relocated or site terminated	2	0
Extension - Open-Label Week 157-240 Other Reason	3	1
Open-Label Post Virologic Failure Phase Adverse Event	2	3
Open-Label Post Virologic Failure Phase Lack of Efficacy	23	19
Open-Label Post Virologic Failure Phase Withdrawal by Subject	2	4
Open-Label Post Virologic Failure Phase Lost to Follow-up	2	2
Open-Label Post Virologic Failure Phase Laboratory Adverse Event	0	2
Open-Label Post Virologic Failure Phase Participant Moved or Site Terminated	0	2
Open-Label Post Virologic Failure Phase Other Reason	4	5

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir 400 mg b.i.d. + OBT n=232 Participants	Placebo + OBT n=118 Participants	Total n=350 Participants Total of all reporting groups
Age, Continuous	46.1 Years n=5 Participants	43.7 Years n=7 Participants	45.3 Years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	15 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	195 Participants n=5 Participants	103 Participants n=7 Participants	298 Participants n=5 Participants
Race/Ethnicity, Customized White	174 participants n=5 Participants	96 participants n=7 Participants	270 participants n=5 Participants
Race/Ethnicity, Customized Black	18 participants n=5 Participants	5 participants n=7 Participants	23 participants n=5 Participants
Race/Ethnicity, Customized Asian	14 participants n=5 Participants	5 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 participants n=5 Participants	1 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Other	20 participants n=5 Participants	11 participants n=7 Participants	31 participants n=5 Participants
Cluster of Differentiation 4 (CD4) Cell Count	156 cells/mm^3 n=5 Participants	153 cells/mm^3 n=7 Participants	155 cells/mm^3 n=5 Participants
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)	40519 copies/mL n=5 Participants	31828 copies/mL n=7 Participants	37352 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=117 Participants
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16	77.7 Percentage of Participants Interval 71.8 to 82.9	41.0 Percentage of Participants Interval 32.0 to 50.5

PRIMARY 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 \<400 copies/mL at Week 48

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=231 Participants	Placebo + OBT n=118 Participants
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48	73.6 Percentage of Participants Interval 67.4 to 79.2	36.4 Percentage of Participants Interval 27.8 to 45.8

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=232 Participants	Placebo + OBT n=117 Participants
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL	57.3 Percentage of Participants Interval 50.7 to 63.8	25.6 Percentage of Participants Interval 18.0 to 34.5

PRIMARY outcome

Timeframe: 240 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 also counted as treatment failures for the subsequent virologic efficacy analyses.

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=232 Participants	Placebo + OBT n=118 Participants
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL	45.3 Percentage of Participants Interval 38.7 to 51.9	20.3 Percentage of Participants Interval 13.5 to 28.7

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=117 Participants
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16	61.6 Percentage of Participants Interval 54.9 to 67.9	33.3 Percentage of Participants Interval 24.9 to 42.6

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=231 Participants	Placebo + OBT n=118 Participants
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48	64.5 Percentage of Participants Interval 58.0 to 70.7	31.4 Percentage of Participants Interval 23.1 to 40.5

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=232 Participants	Placebo + OBT n=117 Participants
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL	53.4 Percentage of Participants Interval 46.8 to 60.0	25.6 Percentage of Participants Interval 18.0 to 34.5

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=232 Participants	Placebo + OBT n=118 Participants
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL	42.2 Percentage of Participants Interval 35.8 to 48.9	18.6 Percentage of Participants Interval 12.1 to 26.9

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=232 Participants	Placebo + OBT n=118 Participants
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response	47.4 Percentage of Participants	24.6 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 (log10 copies/mL)

Outcome measures

Outcome measures
Measure	Raltegravir 400 mg b.i.d. + OBT n=231 Participants	Placebo + OBT n=118 Participants
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16	-1.85 HIV RNA (log10 copies/mL) Interval -1.97 to -1.73	-0.78 HIV RNA (log10 copies/mL) Interval -0.97 to -0.59

SECONDARY outcome

Timeframe: Baseline and Week 48

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 Participants with virologic failure after Week 16 = treatment failures

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=231 Participants	Placebo + OBT n=118 Participants
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48	-1.67 HIV RNA (log10 copies/mL) Interval -1.81 to -1.54	-0.68 HIV RNA (log10 copies/mL) Interval -0.86 to -0.5

SECONDARY outcome

Timeframe: Baseline and Week 156

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 Participants with virologic failure after Week 16 = treatment failures

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=207 Participants	Placebo + OBT n=107 Participants
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)	-1.44 HIV RNA (log10 copies/mL) Interval -1.6 to -1.28	-0.51 HIV RNA (log10 copies/mL) Interval -0.67 to -0.34

SECONDARY outcome

Timeframe: Baseline and Week 240

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 Participants with virologic failure after Week 16 = treatment failures

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=188 Participants	Placebo + OBT n=100 Participants
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)	-1.24 HIV RNA (log10 copies/mL) Interval -1.42 to -1.07	-0.45 HIV RNA (log10 copies/mL) Interval -0.62 to -0.27

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=231 Participants	Placebo + OBT n=118 Participants
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16	82.7 CD4 Cell Count (cells/mm^3) Interval 70.5 to 94.9	31.3 CD4 Cell Count (cells/mm^3) Interval 17.8 to 44.8

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=230 Participants	Placebo + OBT n=119 Participants
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48	120.2 CD4 Cell Count (cells/mm^3) Interval 102.2 to 138.1	49.4 CD4 Cell Count (cells/mm^3) Interval 30.4 to 68.5

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=207 Participants	Placebo + OBT n=107 Participants
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)	170.9 CD4 Cell Count (cells/mm^3) Interval 144.4 to 197.4	71.03 CD4 Cell Count (cells/mm^3) Interval 46.28 to 95.77

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=186 Participants	Placebo + OBT n=101 Participants
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)	193.6 CD4 Cell Count (cells/mm^3) Interval 159.1 to 228.0	68.2 CD4 Cell Count (cells/mm^3) Interval 38.2 to 98.2

Adverse Events

Raltegravir 400 mg b.i.d Plus OBT

Serious events: 97 serious events

Other events: 206 other events

Deaths: 0 deaths

Placebo Plus OBT

Serious events: 46 serious events

Other events: 104 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=232 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=118 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.
Infections and infestations Urosepsis	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Oral candidiasis	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pharyngitis	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pneumocystis jiroveci pneumonia	0.86% 2/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pneumonia	4.7% 11/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	4.2% 5/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pneumonia fungal	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pneumonia pneumococcal	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Progressive multifocal leukoencephalopathy	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pseudomonal sepsis	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Respiratory tract infection	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Sepsis	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Septic shock	0.86% 2/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Sinusitis	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Staphylococcal bacteraemia	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Subcutaneous abscess	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Syphilis	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Tuberculosis of genitourinary system	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Urinary tract infection	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Varicella	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Visceral leishmaniasis	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Subdural haematoma	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Fibula fracture	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Foot fracture	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Humerus fracture	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Incisional hernia	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Inflammation of wound	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Jaw fracture	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Lower limb fracture	0.86% 2/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Overdose	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	1.7% 2/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Post procedural haematuria	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood potassium decreased	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Spinal fracture	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Tendon rupture	0.86% 2/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Neutrophil count decreased	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/232 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Weight decreased	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.00% 0/118 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Metabolism and nutrition disorders Diabetes mellitus	0.43% 1/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	0.85% 1/118 • 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; 94 of 118 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=232 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=118 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 Lymphadenopathy	8.2% 19/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	4.2% 5/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Blood and lymphatic system disorders Anaemia	3.9% 9/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Abdominal pain	6.5% 15/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.3% 11/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Diarrhoea	31.9% 74/232 • Number of events 110 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	28.8% 34/118 • Number of events 70 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Gastritis	3.4% 8/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Haemorrhoids	5.2% 12/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	1.7% 2/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Nausea	12.9% 30/232 • Number of events 38 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	16.9% 20/118 • Number of events 25 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Gastrointestinal disorders Vomiting	7.8% 18/232 • Number of events 26 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	14.4% 17/118 • Number of events 25 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Asthenia	6.5% 15/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.3% 11/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Fatigue	7.8% 18/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Injection site reaction	7.8% 18/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	11.9% 14/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
General disorders Pyrexia	12.1% 28/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	15.3% 18/118 • Number of events 23 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Anogenital warts	4.7% 11/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Bronchitis	18.1% 42/232 • Number of events 71 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	13.6% 16/118 • Number of events 23 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Gastroenteritis	9.5% 22/232 • Number of events 28 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	2.5% 3/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Genital herpes	4.3% 10/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Herpes simplex	5.2% 12/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	2.5% 3/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Herpes zoster	8.6% 20/232 • Number of events 23 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Influenza	10.8% 25/232 • Number of events 28 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	6.8% 8/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Nasopharyngitis	25.0% 58/232 • Number of events 96 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	17.8% 21/118 • Number of events 51 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Oral candidiasis	4.7% 11/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	12.7% 15/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pharyngitis	6.5% 15/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	6.8% 8/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Pneumonia	3.9% 9/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Respiratory tract infection	8.2% 19/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	2.5% 3/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Sinusitis	4.7% 11/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Upper respiratory tract infection	8.6% 20/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Infections and infestations Urinary tract infection	6.0% 14/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Alanine aminotransferase increased	10.3% 24/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Aspartate aminotransferase increased	10.3% 24/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	6.8% 8/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood cholesterol increased	12.1% 28/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	7.6% 9/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Blood triglycerides increased	9.5% 22/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	9.3% 11/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Investigations Weight decreased	2.6% 6/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Metabolism and nutrition disorders Decreased appetite	5.2% 12/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Metabolism and nutrition disorders Diabetes mellitus	2.6% 6/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 14/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Musculoskeletal and connective tissue disorders Back pain	11.2% 26/232 • Number of events 33 • 240 Weeks Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	8.5% 10/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Musculoskeletal and connective tissue disorders Muscle spasms	5.2% 12/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.9% 7/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Musculoskeletal and connective tissue disorders Myalgia	3.9% 9/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	6.8% 8/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Musculoskeletal and connective tissue disorders Pain in extremity	5.2% 12/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	6.9% 16/232 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.	5.1% 6/118 • 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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.