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

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ClinicalTrials.gov Identifier: NCT00293254
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : September 30, 2009
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: raltegravir potassium
Drug: Comparator: placebo
Enrollment 351
Recruitment Details

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).

Pre-assignment Details 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.
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Primary Study - Double-Blind Week 0-48
Started 232 119
Treated 230 119
Continuing in Double-Blind 177 [1] 55 [2]
Completed 177 55
Not Completed 55 64
Reason Not Completed
Never Treated             2             0
Adverse Event             2             1
Death             5             2
Lack of Efficacy             2             2
Lost to Follow-up             3             1
Withdrawal by Subject             5             1
Moved or trial terminated at site             1             0
Entered OLPVF Phase             35             57
[1]
Excludes participants who entered the Open-Label Post-Virologic Failure (OLPVF) Phase
[2]
Excludes participants who entered the OLPVF phase
Period Title: Extension - Double-Blind Week 49-156
Started 177 54 [1]
Completed 120 25
Not Completed 57 29
Reason Not Completed
Adverse Event             4             1
Death             4             1
Lack of Efficacy             3             4
Lost to Follow-up             3             3
Withdrawal by Subject             12             8
Participant Moved/Site Stopped Trial             6             3
Other Reason             10             2
Entered OLPVF Phase             15             7
[1]
1 of 55 participants who completed Week 48 did not enter the extension study.
Period Title: Extension - Open-Label Week 157-240
Started 120 19 [1]
Completed 110 18
Not Completed 10 1
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             1             0
Withdrawal by Subject             1             0
Lost to Follow-up             2             0
Other Reason             4             0
[1]
6 of 25 participants who completed the double-blind phase did not enter this open-label phase.
Period Title: Open-Label Post Virologic Failure Phase
Started 50 [1] 64 [1]
Completed 19 37
Not Completed 31 27
Reason Not Completed
Adverse Event             4             7
Lack of Efficacy             16             14
Withdrawal by Subject             6             3
Lost to Follow-up             3             0
Participant Moved/Site Stopped Trial             1             1
Other Reason             1             2
[1]
Number of participants who failed treatment and consented to enter the OLPVF phase
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 230 119 349
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 230 participants 119 participants 349 participants
45.3
(16 to 67)
46.5
(17 to 70)
45.7
(16 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 119 participants 349 participants
Female
20
   8.7%
12
  10.1%
32
   9.2%
Male
210
  91.3%
107
  89.9%
317
  90.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 230 participants 119 participants 349 participants
White 127 77 204
Black 47 21 68
Asian 2 1 3
Hispanic 47 18 65
Native American 1 0 1
Other 6 2 8
Cluster of Differentiation 4 (CD4) Cell Count  
Mean (Full Range)
Unit of measure:  Cells/mm^3
Number Analyzed 230 participants 119 participants 349 participants
146
(1 to 757)
163
(0 to 674)
152
(0 to 757)
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)  
Geometric Mean (Full Range)
Unit of measure:  copies/mL
Number Analyzed 230 participants 119 participants 349 participants
49159
(200 to 750000)
47850
(200 to 750000)
48709
(200 to 750000)
1.Primary Outcome
Title Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
Hide Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
Time Frame 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 229 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
77.3
(71.3 to 82.6)
42.9
(33.8 to 52.3)
2.Primary Outcome
Title Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
Hide Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 228 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
71.1
(64.7 to 76.8)
37.8
(29.1 to 47.2)
3.Primary Outcome
Title Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Hide Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
Time Frame 156 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 229 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
50.2
(43.6 to 56.9)
21.0
(14.1 to 29.4)
4.Primary Outcome
Title Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Hide Description Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
Time Frame 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
Overall Number of Participants Analyzed 230 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
45.7
(39.1 to 52.3)
13.4
(7.9 to 20.9)
5.Secondary Outcome
Title Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Hide Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
Time Frame 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 229 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
62.0
(55.4 to 68.3)
36.1
(27.5 to 45.4)
6.Secondary Outcome
Title Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Hide Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
Time Frame 48 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 228 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
59.6
(53.0 to 66.1)
34.5
(26.0 to 43.7)
7.Secondary Outcome
Title Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Hide Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
Time Frame 156 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 229 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
47.6
(41.0 to 54.3)
17.6
(11.3 to 25.7)
8.Secondary Outcome
Title Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Hide Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
Time Frame 240 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
Overall Number of Participants Analyzed 230 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
41.3
(34.9 to 48.0)
13.4
(7.9 to 20.9)
9.Secondary Outcome
Title Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
Hide Description 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).
Time Frame 156 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 230 119
Measure Type: Number
Unit of Measure: Percentage of Participants
44.3 17.6
10.Secondary Outcome
Title Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
Hide Description Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 222 117
Mean (95% Confidence Interval)
Unit of Measure: HIV RNA (log10 copies/mL)
-1.92
(-2.05 to -1.78)
-1.06
(-1.26 to -0.86)
11.Secondary Outcome
Title Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Hide Description Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 216 114
Mean (95% Confidence Interval)
Unit of Measure: HIV RNA (log10 copies/mL)
-1.75
(-1.90 to -1.59)
-0.87
(-1.08 to -0.67)
12.Secondary Outcome
Title Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Hide Description Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
Time Frame Baseline and Week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 189 102
Mean (95% Confidence Interval)
Unit of Measure: HIV RNA (log10 copies/mL)
-1.37
(-1.55 to -1.20)
-0.52
(-0.71 to -0.33)
13.Secondary Outcome
Title Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Hide Description Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
Time Frame Baseline and Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
Overall Number of Participants Analyzed 182 95
Mean (95% Confidence Interval)
Unit of Measure: HIV RNA (log10 copies/mL)
-1.31
(-1.49 to -1.13)
-0.41
(-0.59 to -0.23)
14.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Hide Description Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 219 117
Mean (95% Confidence Interval)
Unit of Measure: CD4 Cell Count (cells/mm^3)
85.8
(72.7 to 99.0)
39.9
(26.2 to 53.6)
15.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Hide Description Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.

Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 217 114
Mean (95% Confidence Interval)
Unit of Measure: CD4 Cell Count (cells/mm^3)
98.4
(84.1 to 112.7)
39.8
(23.5 to 56.1)
16.Secondary Outcome
Title Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
Hide Description Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.

Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 189 101
Mean (95% Confidence Interval)
Unit of Measure: CD4 Cell Count (cells/mm^3)
157.2
(130.7 to 183.6)
54.2
(30.0 to 78.3)
17.Secondary Outcome
Title Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Hide Description Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 240
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.

Arm/Group Title Raltegravir 400 mg b.i.d. + OBT Placebo + OBT
Hide Arm/Group Description:
Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
Overall Number of Participants Analyzed 181 95
Mean (95% Confidence Interval)
Unit of Measure: CD4 Cell Count (Cells/mm^3)
172.1
(141.7 to 202.5)
54.1
(27.1 to 81.0)
Time Frame 240 Weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/230 (34.78%)      54/119 (45.38%)    
Blood and lymphatic system disorders     
Anaemia  1  5/230 (2.17%)  6 1/119 (0.84%)  1
Aplasia pure red cell  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Febrile neutropenia  1  1/230 (0.43%)  2 1/119 (0.84%)  1
Neutropenia  1  1/230 (0.43%)  1 2/119 (1.68%)  2
Pancytopenia  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Angina unstable  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Atrial fibrillation  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Bradycardia  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Cardiac failure  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Cardiac failure congestive  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Cardio-respiratory arrest  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Coronary artery disease  1  3/230 (1.30%)  3 1/119 (0.84%)  1
Coronary artery occlusion  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Left ventricular dysfunction  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Mitral valve incompetence  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Myocardial infarction  1  1/230 (0.43%)  1 3/119 (2.52%)  3
Ventricular tachycardia  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Eye disorders     
Blindness cortical  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Abdominal pain upper  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Anal fistula  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Ascites  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Colitis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Colonic polyp  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Diarrhoea  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Dyspepsia  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Gastric haemorrhage  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Gastrointestinal haemorrhage  1  2/230 (0.87%)  3 0/119 (0.00%)  0
Ileitis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Intestinal obstruction  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Lower gastrointestinal haemorrhage  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Nausea  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Oesophagitis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Pancreatic mass  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Pancreatitis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Pancreatitis necrotising  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Peritonitis  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Small intestinal obstruction  1  2/230 (0.87%)  3 0/119 (0.00%)  0
Vomiting  1  1/230 (0.43%)  1 1/119 (0.84%)  1
General disorders     
Asthenia  1  0/230 (0.00%)  0 1/119 (0.84%)  2
Death  1  2/230 (0.87%)  2 3/119 (2.52%)  3
Malaise  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Non-cardiac chest pain  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Pyrexia  1  5/230 (2.17%)  5 3/119 (2.52%)  3
Hepatobiliary disorders     
Cholecystitis acute  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Cholelithiasis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Portal vein thrombosis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Immune system disorders     
Drug hypersensitivity  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Hypersensitivity  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Immune reconstitution syndrome  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Infections and infestations     
AIDS dementia complex  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Abdominal abscess  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Abdominal wall abscess  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Abscess bacterial  1  2/230 (0.87%)  3 1/119 (0.84%)  1
Abscess limb  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Acinetobacter bacteraemia  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Acute HIV infection  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Appendicitis  1  0/230 (0.00%)  0 3/119 (2.52%)  3
Appendicitis perforated  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Arthritis bacterial  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Aspergillosis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Atypical mycobacterial lymphadenitis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Bronchitis  1  1/230 (0.43%)  2 0/119 (0.00%)  0
Cellulitis  1  5/230 (2.17%)  5 1/119 (0.84%)  1
Clostridium difficile colitis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Cryptococcosis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Cryptosporidiosis infection  1  0/230 (0.00%)  0 1/119 (0.84%)  2
Cystitis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Cytomegalovirus chorioretinitis  1  1/230 (0.43%)  1 3/119 (2.52%)  3
Cytomegalovirus colitis  1  2/230 (0.87%)  2 0/119 (0.00%)  0
Endocarditis  1  0/230 (0.00%)  0 1/119 (0.84%)  2
Gastroenteritis  1  0/230 (0.00%)  0 3/119 (2.52%)  3
Gastroenteritis salmonella  1  0/230 (0.00%)  0 1/119 (0.84%)  3
Gastroenteritis viral  1  2/230 (0.87%)  2 1/119 (0.84%)  1
HIV wasting syndrome  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Hepatitis C  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Herpes zoster disseminated  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Incision site infection  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Infection  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Influenza  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Meningitis aseptic  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Meningitis cryptococcal  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Mycobacterium avium complex infection  1  0/230 (0.00%)  0 2/119 (1.68%)  2
Oesophageal candidiasis  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Osteomyelitis  1  1/230 (0.43%)  2 0/119 (0.00%)  0
Otitis media  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Pharyngeal abscess  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Pneumococcal sepsis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Pneumocystis jiroveci pneumonia  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Pneumonia  1  12/230 (5.22%)  17 5/119 (4.20%)  5
Postoperative wound infection  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Progressive multifocal leukoencephalopathy  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Pseudomembranous colitis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Pyelonephritis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Salmonella bacteraemia  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Sepsis  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Septic shock  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Sinusitis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Subcutaneous abscess  1  1/230 (0.43%)  4 0/119 (0.00%)  0
Tuberculosis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Upper respiratory tract infection  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Ureteritis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Urinary tract infection  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Urosepsis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Viral infection  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Femur fracture  1  1/230 (0.43%)  2 0/119 (0.00%)  0
Head injury  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Hip fracture  1  1/230 (0.43%)  1 2/119 (1.68%)  2
Intentional overdose  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Overdose  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Post procedural haemorrhage  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Subdural haematoma  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Ulna fracture  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Investigations     
Blood creatinine increased  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Neutrophil count decreased  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Weight decreased  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Metabolism and nutrition disorders     
Cachexia  1  2/230 (0.87%)  2 0/119 (0.00%)  0
Dehydration  1  3/230 (1.30%)  4 1/119 (0.84%)  2
Diabetes mellitus  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Failure to thrive  1  0/230 (0.00%)  0 2/119 (1.68%)  2
Hyperglycaemia  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Hypovolaemia  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Type 2 diabetes mellitus  1  2/230 (0.87%)  2 0/119 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Osteonecrosis  1  2/230 (0.87%)  3 0/119 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer  1  3/230 (1.30%)  3 0/119 (0.00%)  0
Anal cancer stage 0  1  1/230 (0.43%)  1 0/119 (0.00%)  0
B-cell lymphoma  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Basal cell carcinoma  1  1/230 (0.43%)  3 2/119 (1.68%)  5
Bowen's disease  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Breast cancer  1  2/230 (0.87%)  2 0/119 (0.00%)  0
Colon cancer  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Head and neck cancer  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Hepatic neoplasm malignant  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Hodgkin's disease  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Kaposi's sarcoma AIDS related  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Lip neoplasm malignant stage unspecified  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Lung neoplasm  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Lung squamous cell carcinoma stage unspecified  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Lymphoma  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Malignant anorectal neoplasm  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Metastases to bone  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Metastases to lymph nodes  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Metastatic malignant melanoma  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Non-Hodgkin's lymphoma  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Prostate cancer  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Rectal cancer stage 0  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Squamous cell carcinoma  1  4/230 (1.74%)  5 3/119 (2.52%)  3
Squamous cell carcinoma of skin  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Nervous system disorders     
Cerebral infarction  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Cerebrovascular accident  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Convulsion  1  2/230 (0.87%)  2 1/119 (0.84%)  1
Dizziness  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Migraine  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Neuralgia  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Presyncope  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Syncope  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Transient ischaemic attack  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Psychiatric disorders     
Bipolar disorder  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Depression  1  2/230 (0.87%)  2 2/119 (1.68%)  2
Major depression  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Mental status changes  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Suicidal ideation  1  0/230 (0.00%)  0 1/119 (0.84%)  2
Suicide attempt  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Renal and urinary disorders     
Haematuria  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Nephrolithiasis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Renal failure  1  1/230 (0.43%)  1 1/119 (0.84%)  2
Renal failure acute  1  1/230 (0.43%)  1 2/119 (1.68%)  2
Renal tubular necrosis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Reproductive system and breast disorders     
Prostatitis  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  5/230 (2.17%)  5 0/119 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Dyspnoea  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Pulmonary embolism  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Pulmonary infarction  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Respiratory failure  1  1/230 (0.43%)  1 1/119 (0.84%)  1
Skin and subcutaneous tissue disorders     
Henoch-Schonlein purpura  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Swelling face  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Vascular disorders     
Arteriosclerosis  1  2/230 (0.87%)  3 0/119 (0.00%)  0
Deep vein thrombosis  1  2/230 (0.87%)  3 0/119 (0.00%)  0
Hypertension  1  1/230 (0.43%)  1 0/119 (0.00%)  0
Hypertensive emergency  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Orthostatic hypotension  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Venous thrombosis  1  0/230 (0.00%)  0 1/119 (0.84%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   214/230 (93.04%)      111/119 (93.28%)    
Blood and lymphatic system disorders     
Anaemia  1  9/230 (3.91%)  9 9/119 (7.56%)  10
Lymphadenopathy  1  19/230 (8.26%)  24 4/119 (3.36%)  4
Eye disorders     
Conjunctivitis  1  17/230 (7.39%)  18 2/119 (1.68%)  2
Gastrointestinal disorders     
Abdominal distension  1  15/230 (6.52%)  18 6/119 (5.04%)  6
Abdominal pain  1  25/230 (10.87%)  31 7/119 (5.88%)  8
Abdominal pain upper  1  17/230 (7.39%)  19 11/119 (9.24%)  11
Constipation  1  15/230 (6.52%)  19 5/119 (4.20%)  6
Diarrhoea  1  75/230 (32.61%)  108 35/119 (29.41%)  41
Dry mouth  1  2/230 (0.87%)  2 7/119 (5.88%)  7
Flatulence  1  17/230 (7.39%)  20 5/119 (4.20%)  7
Haemorrhoids  1  8/230 (3.48%)  8 6/119 (5.04%)  6
Nausea  1  41/230 (17.83%)  57 30/119 (25.21%)  40
Vomiting  1  25/230 (10.87%)  41 17/119 (14.29%)  19
General disorders     
Asthenia  1  12/230 (5.22%)  13 2/119 (1.68%)  2
Chest pain  1  13/230 (5.65%)  15 4/119 (3.36%)  4
Fatigue  1  45/230 (19.57%)  57 18/119 (15.13%)  22
Injection site reaction  1  35/230 (15.22%)  41 14/119 (11.76%)  16
Oedema peripheral  1  12/230 (5.22%)  13 9/119 (7.56%)  10
Pyrexia  1  29/230 (12.61%)  32 24/119 (20.17%)  35
Infections and infestations     
Anogenital warts  1  12/230 (5.22%)  15 4/119 (3.36%)  4
Bronchitis  1  34/230 (14.78%)  44 15/119 (12.61%)  18
Cellulitis  1  11/230 (4.78%)  15 7/119 (5.88%)  7
Folliculitis  1  12/230 (5.22%)  14 4/119 (3.36%)  4
Furuncle  1  4/230 (1.74%)  4 6/119 (5.04%)  6
Gastroenteritis  1  13/230 (5.65%)  14 6/119 (5.04%)  6
Herpes zoster  1  27/230 (11.74%)  30 5/119 (4.20%)  5
Influenza  1  17/230 (7.39%)  21 9/119 (7.56%)  14
Nasopharyngitis  1  29/230 (12.61%)  50 15/119 (12.61%)  20
Onychomycosis  1  8/230 (3.48%)  9 7/119 (5.88%)  8
Oral candidiasis  1  12/230 (5.22%)  12 11/119 (9.24%)  12
Pneumonia  1  14/230 (6.09%)  19 10/119 (8.40%)  14
Sinusitis  1  35/230 (15.22%)  50 15/119 (12.61%)  18
Upper respiratory tract infection  1  76/230 (33.04%)  114 29/119 (24.37%)  47
Urinary tract infection  1  11/230 (4.78%)  12 11/119 (9.24%)  18
Investigations     
Alanine aminotransferase increased  1  18/230 (7.83%)  29 9/119 (7.56%)  11
Aspartate aminotransferase increased  1  20/230 (8.70%)  27 9/119 (7.56%)  12
Blood bilirubin increased  1  6/230 (2.61%)  7 6/119 (5.04%)  10
Blood cholesterol increased  1  10/230 (4.35%)  11 9/119 (7.56%)  11
Blood creatine phosphokinase increased  1  21/230 (9.13%)  24 8/119 (6.72%)  8
Blood creatinine increased  1  18/230 (7.83%)  37 11/119 (9.24%)  17
Blood glucose increased  1  13/230 (5.65%)  28 6/119 (5.04%)  7
Blood phosphorus decreased  1  3/230 (1.30%)  3 6/119 (5.04%)  8
Blood triglycerides increased  1  22/230 (9.57%)  30 14/119 (11.76%)  15
Weight decreased  1  14/230 (6.09%)  15 8/119 (6.72%)  9
Metabolism and nutrition disorders     
Decreased appetite  1  13/230 (5.65%)  16 10/119 (8.40%)  10
Hyperlipidaemia  1  12/230 (5.22%)  12 1/119 (0.84%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  24/230 (10.43%)  32 15/119 (12.61%)  18
Back pain  1  26/230 (11.30%)  27 14/119 (11.76%)  17
Musculoskeletal pain  1  16/230 (6.96%)  17 5/119 (4.20%)  6
Myalgia  1  14/230 (6.09%)  16 13/119 (10.92%)  19
Pain in extremity  1  27/230 (11.74%)  35 9/119 (7.56%)  12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  21/230 (9.13%)  23 8/119 (6.72%)  10
Nervous system disorders     
Dizziness  1  22/230 (9.57%)  27 10/119 (8.40%)  13
Headache  1  39/230 (16.96%)  62 19/119 (15.97%)  24
Hypoaesthesia  1  7/230 (3.04%)  10 8/119 (6.72%)  10
Neuropathy peripheral  1  15/230 (6.52%)  19 9/119 (7.56%)  11
Paraesthesia  1  10/230 (4.35%)  12 6/119 (5.04%)  7
Psychiatric disorders     
Anxiety  1  7/230 (3.04%)  7 13/119 (10.92%)  14
Depression  1  15/230 (6.52%)  17 11/119 (9.24%)  12
Insomnia  1  22/230 (9.57%)  27 11/119 (9.24%)  12
Respiratory, thoracic and mediastinal disorders     
Cough  1  26/230 (11.30%)  32 21/119 (17.65%)  29
Dyspnoea  1  4/230 (1.74%)  5 6/119 (5.04%)  6
Oropharyngeal pain  1  17/230 (7.39%)  18 7/119 (5.88%)  8
Sinus congestion  1  6/230 (2.61%)  7 8/119 (6.72%)  8
Skin and subcutaneous tissue disorders     
Night sweats  1  11/230 (4.78%)  15 6/119 (5.04%)  7
Pruritus  1  7/230 (3.04%)  8 7/119 (5.88%)  8
Rash  1  30/230 (13.04%)  36 12/119 (10.08%)  17
Vascular disorders     
Hypertension  1  21/230 (9.13%)  21 5/119 (4.20%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00293254     History of Changes
Other Study ID Numbers: 0518-019
2005_097
First Submitted: February 15, 2006
First Posted: February 17, 2006
Results First Submitted: August 20, 2009
Results First Posted: September 30, 2009
Last Update Posted: March 21, 2017