A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019 EXT2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00293254
First received: February 15, 2006
Last updated: August 30, 2013
Last verified: August 2013
Results First Received: August 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: raltegravir potassium
Drug: Comparator: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Participant Flow for 4 periods

Period 1:   Primary Study - Double-Blind Week 0-48
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     232     119  
Treated     230     119  
Continuing in Double-Blind     177 [1]   55 [2]
COMPLETED     177     55  
NOT COMPLETED     55     64  
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 2:   Extension - Double-Blind Week 49-156
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     177     54 [1]
COMPLETED     120     25  
NOT COMPLETED     57     29  
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 3:   Extension - Open-Label Week 157-240
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     120     19 [1]
COMPLETED     110     18  
NOT COMPLETED     10     1  
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 4:   Open-Label Post Virologic Failure Phase
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     50 [1]   64 [1]
COMPLETED     19     37  
NOT COMPLETED     31     27  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.
Total Total of all reporting groups

Baseline Measures
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT     Total  
Number of Participants  
[units: participants]
  230     119     349  
Age  
[units: Years]
Mean ( Full Range )
  45.3  
  ( 16 to 67 )  
  46.5  
  ( 17 to 70 )  
  45.7  
  ( 16 to 70 )  
Gender  
[units: participants]
     
Female     20     12     32  
Male     210     107     317  
Race/Ethnicity, Customized  
[units: 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  
[units: cells/mm^3]
Mean ( Full Range )
  146  
  ( 1 to 757 )  
  163  
  ( 0 to 674 )  
  152  
  ( 0 to 757 )  
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)  
[units: copies/mL]
Geometric Mean ( Full Range )
  49159  
  ( 200 to 750000 )  
  47850  
  ( 200 to 750000 )  
  48709  
  ( 200 to 750000 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16   [ Time Frame: 16 Weeks ]

2.  Primary:   Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

3.  Primary:   Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL   [ Time Frame: 156 Weeks ]

4.  Primary:   Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL   [ Time Frame: 240 Weeks ]

5.  Secondary:   Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16   [ Time Frame: 16 Weeks ]

6.  Secondary:   Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

7.  Secondary:   Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL   [ Time Frame: 156 Weeks ]

8.  Secondary:   Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL   [ Time Frame: 240 Weeks ]

9.  Secondary:   Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response   [ Time Frame: 156 Weeks ]

10.  Secondary:   Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16   [ Time Frame: Baseline and Week 16 ]

11.  Secondary:   Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48   [ Time Frame: Baseline and Week 48 ]

12.  Secondary:   Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)   [ Time Frame: Baseline and Week 156 ]

13.  Secondary:   Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)   [ Time Frame: Baseline and Week 240 ]

14.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16   [ Time Frame: Baseline and Week 16 ]

15.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48   [ Time Frame: Baseline and Week 48 ]

16.  Secondary:   Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)   [ Time Frame: Baseline and Week 156 ]

17.  Secondary:   Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)   [ Time Frame: Baseline and Week 240 ]


  Serious Adverse Events
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Time Frame 240 Weeks
Additional 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.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. Plus OBT 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 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.

Serious Adverse Events
    Raltegravir 400 mg b.i.d. Plus OBT     Placebo Plus OBT  
Total, serious adverse events      
# participants affected / at risk     80/230 (34.78%)     54/119 (45.38%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     5/230 (2.17%)     1/119 (0.84%)  
# events     6     1  
Aplasia pure red cell † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Febrile neutropenia † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     2     1  
Neutropenia † 1    
# participants affected / at risk     1/230 (0.43%)     2/119 (1.68%)  
# events     1     2  
Pancytopenia † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Angina unstable † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Atrial fibrillation † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Bradycardia † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Cardiac failure † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Cardiac failure congestive † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Cardio-respiratory arrest † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Coronary artery disease † 1    
# participants affected / at risk     3/230 (1.30%)     1/119 (0.84%)  
# events     3     1  
Coronary artery occlusion † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Left ventricular dysfunction † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Mitral valve incompetence † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Myocardial infarction † 1    
# participants affected / at risk     1/230 (0.43%)     3/119 (2.52%)  
# events     1     3  
Ventricular tachycardia † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Eye disorders      
Blindness cortical † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Abdominal pain upper † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Anal fistula † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Ascites † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Colitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Colonic polyp † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Diarrhoea † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Dyspepsia † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Gastric haemorrhage † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     3     0  
Ileitis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Intestinal obstruction † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Lower gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Nausea † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Oesophagitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Pancreatic mass † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Pancreatitis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Pancreatitis necrotising † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Peritonitis † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Small intestinal obstruction † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     3     0  
Vomiting † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
General disorders      
Asthenia † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     2  
Death † 1    
# participants affected / at risk     2/230 (0.87%)     3/119 (2.52%)  
# events     2     3  
Malaise † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Non-cardiac chest pain † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Pyrexia † 1    
# participants affected / at risk     5/230 (2.17%)     3/119 (2.52%)  
# events     5     3  
Hepatobiliary disorders      
Cholecystitis acute † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Cholelithiasis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Portal vein thrombosis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Hypersensitivity † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Immune reconstitution syndrome † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Infections and infestations      
AIDS dementia complex † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Abdominal abscess † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Abdominal wall abscess † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Abscess bacterial † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     3     1  
Abscess limb † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Acinetobacter bacteraemia † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Acute HIV infection † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Appendicitis † 1    
# participants affected / at risk     0/230 (0.00%)     3/119 (2.52%)  
# events     0     3  
Appendicitis perforated † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Arthritis bacterial † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Aspergillosis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Atypical mycobacterial lymphadenitis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Bronchitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     2     0  
Cellulitis † 1    
# participants affected / at risk     5/230 (2.17%)     1/119 (0.84%)  
# events     5     1  
Clostridium difficile colitis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Cryptococcosis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Cryptosporidiosis infection † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     2  
Cystitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Cytomegalovirus chorioretinitis † 1    
# participants affected / at risk     1/230 (0.43%)     3/119 (2.52%)  
# events     1     3  
Cytomegalovirus colitis † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     2     0  
Endocarditis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     2  
Gastroenteritis † 1    
# participants affected / at risk     0/230 (0.00%)     3/119 (2.52%)  
# events     0     3  
Gastroenteritis salmonella † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     3  
Gastroenteritis viral † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
HIV wasting syndrome † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Hepatitis C † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Herpes zoster disseminated † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Incision site infection † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Infection † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Influenza † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Meningitis aseptic † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Meningitis cryptococcal † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Mycobacterium avium complex infection † 1    
# participants affected / at risk     0/230 (0.00%)     2/119 (1.68%)  
# events     0     2  
Oesophageal candidiasis † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Osteomyelitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     2     0  
Otitis media † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Pharyngeal abscess † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Pneumococcal sepsis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Pneumonia † 1    
# participants affected / at risk     12/230 (5.22%)     5/119 (4.20%)  
# events     17     5  
Postoperative wound infection † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Progressive multifocal leukoencephalopathy † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Pseudomembranous colitis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Pyelonephritis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Salmonella bacteraemia † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Sepsis † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Septic shock † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Sinusitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Subcutaneous abscess † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     4     0  
Tuberculosis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Upper respiratory tract infection † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Ureteritis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Urinary tract infection † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Urosepsis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Viral infection † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Injury, poisoning and procedural complications      
Accidental overdose † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Femur fracture † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     2     0  
Head injury † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Hip fracture † 1    
# participants affected / at risk     1/230 (0.43%)     2/119 (1.68%)  
# events     1     2  
Intentional overdose † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Overdose † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Post procedural haemorrhage † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Subdural haematoma † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Ulna fracture † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Investigations      
Blood creatinine increased † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Neutrophil count decreased † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Weight decreased † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Metabolism and nutrition disorders      
Cachexia † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     2     0  
Dehydration † 1    
# participants affected / at risk     3/230 (1.30%)     1/119 (0.84%)  
# events     4     2  
Diabetes mellitus † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Failure to thrive † 1    
# participants affected / at risk     0/230 (0.00%)     2/119 (1.68%)  
# events     0     2  
Hyperglycaemia † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Hypovolaemia † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Type 2 diabetes mellitus † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     2     0  
Musculoskeletal and connective tissue disorders      
Bone pain † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Osteonecrosis † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     3     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Anal cancer † 1    
# participants affected / at risk     3/230 (1.30%)     0/119 (0.00%)  
# events     3     0  
Anal cancer stage 0 † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
B-cell lymphoma † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Basal cell carcinoma † 1    
# participants affected / at risk     1/230 (0.43%)     2/119 (1.68%)  
# events     3     5  
Bowen's disease † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Breast cancer † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     2     0  
Colon cancer † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Head and neck cancer † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Hepatic neoplasm malignant † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Hodgkin's disease † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Kaposi's sarcoma AIDS related † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Lip neoplasm malignant stage unspecified † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Lung neoplasm † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Lung squamous cell carcinoma stage unspecified † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Lymphoma † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Malignant anorectal neoplasm † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Metastases to bone † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Metastases to lymph nodes † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Metastatic malignant melanoma † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Non-Hodgkin's lymphoma † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Prostate cancer † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Rectal cancer stage 0 † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Squamous cell carcinoma † 1    
# participants affected / at risk     4/230 (1.74%)     3/119 (2.52%)  
# events     5     3  
Squamous cell carcinoma of skin † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Nervous system disorders      
Cerebral infarction † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Cerebrovascular accident † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Convulsion † 1    
# participants affected / at risk     2/230 (0.87%)     1/119 (0.84%)  
# events     2     1  
Dizziness † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Migraine † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Neuralgia † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Presyncope † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Syncope † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Transient ischaemic attack † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Psychiatric disorders      
Bipolar disorder † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Depression † 1    
# participants affected / at risk     2/230 (0.87%)     2/119 (1.68%)  
# events     2     2  
Major depression † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Mental status changes † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Suicidal ideation † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     2  
Suicide attempt † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Renal and urinary disorders      
Haematuria † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Nephrolithiasis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Renal failure † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     2  
Renal failure acute † 1    
# participants affected / at risk     1/230 (0.43%)     2/119 (1.68%)  
# events     1     2  
Renal tubular necrosis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Reproductive system and breast disorders      
Prostatitis † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Asthma † 1    
# participants affected / at risk     5/230 (2.17%)     0/119 (0.00%)  
# events     5     0  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Dyspnoea † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Pulmonary embolism † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Pulmonary infarction † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Respiratory failure † 1    
# participants affected / at risk     1/230 (0.43%)     1/119 (0.84%)  
# events     1     1  
Skin and subcutaneous tissue disorders      
Henoch-Schonlein purpura † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Swelling face † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Vascular disorders      
Arteriosclerosis † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     3     0  
Deep vein thrombosis † 1    
# participants affected / at risk     2/230 (0.87%)     0/119 (0.00%)  
# events     3     0  
Hypertension † 1    
# participants affected / at risk     1/230 (0.43%)     0/119 (0.00%)  
# events     1     0  
Hypertensive emergency † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Orthostatic hypotension † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Venous thrombosis † 1    
# participants affected / at risk     0/230 (0.00%)     1/119 (0.84%)  
# events     0     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


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