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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00293267
First received: February 14, 2006
Last updated: October 22, 2013
Last verified: October 2013
Results First Received: August 18, 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: 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

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     234     118  
Treated     232     118  
Continuing in Double-Blind     193 [1]   50  
COMPLETED     193     50  
NOT COMPLETED     41     68  
Never Treated                 2                 0  
Adverse Event                 1                 1  
Death                 3                 3  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 1                 1  
Entered OLPVF Phase                 33                 60  
[1] Excludes participants who entered the open-label post virological failure (OLPVF) phase

Period 2:   Extension - Double-Blind Week 49-156
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     191 [1]   50  
COMPLETED     139     35  
NOT COMPLETED     52     15  
Adverse Event                 1                 4  
Lack of Efficacy                 7                 1  
Lost to Follow-up                 4                 0  
Withdrawal by Subject                 13                 4  
Death                 3                 0  
Participant relocated or site terminated                 2                 0  
Other Reason                 7                 0  
Entered OLPVF Phase                 15                 6  
[1] 2 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     131 [1]   28 [2]
COMPLETED     111     26  
NOT COMPLETED     20     2  
Adverse Event                 5                 0  
Lack of Efficacy                 7                 0  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 1  
Participant relocated or site terminated                 2                 0  
Other Reason                 3                 1  
[1] 8 of 139 participants who completed the double-blind phase did not enter this open-label phase
[2] 7 of 35 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     48 [1]   66 [1]
COMPLETED     15     29  
NOT COMPLETED     33     37  
Adverse Event                 2                 3  
Lack of Efficacy                 23                 19  
Withdrawal by Subject                 2                 4  
Lost to Follow-up                 2                 2  
Laboratory Adverse Event                 0                 2  
Participant Moved or Site Terminated                 0                 2  
Other Reason                 4                 5  
[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]
  232     118     350  
Age  
[units: Years]
Mean ( Full Range )
  46.1  
  ( 16 to 74 )  
  43.7  
  ( 19 to 64 )  
  45.3  
  ( 16 to 74 )  
Gender  
[units: participants]
     
Female     37     15     52  
Male     195     103     298  
Race/Ethnicity, Customized  
[units: participants]
     
White     174     96     270  
Black     18     5     23  
Asian     14     5     19  
Hispanic     6     1     7  
Other     20     11     31  
Cluster of Differentiation 4 (CD4) Cell Count  
[units: cells/mm^3]
Mean ( Full Range )
  156  
  ( 1 to 792 )  
  153  
  ( 3 to 759 )  
  155  
  ( 1 to 792 )  
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)  
[units: copies/mL]
Geometric Mean ( Full Range )
  40519  
  ( 441 to 750000 )  
  31828  
  ( 200 to 750000 )  
  37352  
  ( 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 (log10 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; 94 of 118 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     97/232 (41.81%)     46/118 (38.98%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Haemolytic anaemia † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Haemolytic uraemic syndrome † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Leukopenia † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     2  
Neutropenia † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Splenic vein thrombosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Acute myocardial infarction † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Angina pectoris † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Angina unstable † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Cardiac arrest † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Cardio-respiratory arrest † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Coronary artery disease † 1    
# participants affected / at risk     1/232 (0.43%)     1/118 (0.85%)  
# events     1     1  
Intracardiac thrombus † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Myocardial infarction † 1    
# participants affected / at risk     4/232 (1.72%)     2/118 (1.69%)  
# events     5     3  
Pericarditis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Congenital, familial and genetic disorders      
Phimosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Ear and labyrinth disorders      
Hypoacusis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Vertigo † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Endocrine disorders      
Hyperthyroidism † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Myxoedema † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Eye disorders      
Uveitis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Anal fissure † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Ascites † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Constipation † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Diarrhoea † 1    
# participants affected / at risk     3/232 (1.29%)     0/118 (0.00%)  
# events     4     0  
Enteritis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Gastric varices † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Gastritis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     2     0  
Haemorrhoids † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Hernial eventration † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Inguinal hernia † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Intestinal obstruction † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Intestinal perforation † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Mesenteric vein thrombosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Oesophagitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Rectal haemorrhage † 1    
# participants affected / at risk     2/232 (0.86%)     1/118 (0.85%)  
# events     2     1  
Rectal perforation † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Rectal stenosis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Umbilical hernia † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Upper gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Varices oesophageal † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
General disorders      
Asthenia † 1    
# participants affected / at risk     2/232 (0.86%)     1/118 (0.85%)  
# events     2     1  
Chest pain † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Malaise † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Multi-organ failure † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Oedema peripheral † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Pyrexia † 1    
# participants affected / at risk     3/232 (1.29%)     3/118 (2.54%)  
# events     3     11  
Soft tissue inflammation † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Hepatobiliary disorders      
Cholangitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Gallbladder disorder † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Hepatitis † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     3     0  
Hepatitis toxic † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Portal hypertension † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Portal vein thrombosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Hypersensitivity † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     2     0  
Infections and infestations      
Anogenital warts † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Appendicitis † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Bone tuberculosis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Bronchopneumonia † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Candidiasis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Carbuncle † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Cellulitis † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Choriomeningitis lymphocytic † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Cytomegalovirus chorioretinitis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Cytomegalovirus colitis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Cytomegalovirus hepatitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Cytomegalovirus infection † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Diarrhoea infectious † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Disseminated cytomegaloviral infection † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Dysentery † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
End stage AIDS † 1    
# participants affected / at risk     1/232 (0.43%)     1/118 (0.85%)  
# events     1     1  
Endophthalmitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     2     0  
Epidermodysplasia verruciformis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Erythema infectiosum † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Fallopian tube abscess † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Gastroenteritis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Gastroenteritis viral † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Genital herpes † 1    
# participants affected / at risk     3/232 (1.29%)     0/118 (0.00%)  
# events     3     0  
Giardiasis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
HIV infection † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Influenza † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Leishmaniasis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     4  
Lower respiratory tract infection † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Meningitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Meningitis cryptococcal † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Mycobacterial infection † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Mycobacterium avium complex infection † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Oesophageal candidiasis † 1    
# participants affected / at risk     1/232 (0.43%)     3/118 (2.54%)  
# events     1     3  
Oral candidiasis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Pharyngitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Pneumonia † 1    
# participants affected / at risk     11/232 (4.74%)     5/118 (4.24%)  
# events     11     6  
Pneumonia fungal † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Pneumonia pneumococcal † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Progressive multifocal leukoencephalopathy † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Pseudomonal sepsis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Respiratory tract infection † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Sepsis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Septic shock † 1    
# participants affected / at risk     2/232 (0.86%)     1/118 (0.85%)  
# events     3     2  
Sinusitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Staphylococcal bacteraemia † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Subcutaneous abscess † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Syphilis † 1    
# participants affected / at risk     1/232 (0.43%)     1/118 (0.85%)  
# events     1     1  
Tuberculosis of genitourinary system † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Urinary tract infection † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Urosepsis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Varicella † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Visceral leishmaniasis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Injury, poisoning and procedural complications      
Accidental overdose † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Fibula fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Foot fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Humerus fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Incisional hernia † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Inflammation of wound † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Intentional overdose † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Jaw fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Lower limb fracture † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Overdose † 1    
# participants affected / at risk     1/232 (0.43%)     2/118 (1.69%)  
# events     1     2  
Post procedural haematuria † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Skull fracture † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Spinal fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Subdural haematoma † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Tendon rupture † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Thoracic vertebral fracture † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     3  
Tibia fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Toxicity to various agents † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Wrist fracture † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Investigations      
Alanine aminotransferase increased † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Blood potassium decreased † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Neutrophil count decreased † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     3     0  
Weight decreased † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Metabolism and nutrition disorders      
Diabetes mellitus † 1    
# participants affected / at risk     1/232 (0.43%)     1/118 (0.85%)  
# events     2     1  
Diabetic complication † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Diabetic foot † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     2     0  
Hypoglycaemia † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Malnutrition † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Metabolic acidosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Obesity † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Musculoskeletal and connective tissue disorders      
Intervertebral disc protrusion † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Muscular weakness † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Musculoskeletal pain † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Osteonecrosis † 1    
# participants affected / at risk     3/232 (1.29%)     0/118 (0.00%)  
# events     3     0  
Osteoporotic fracture † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Anal cancer † 1    
# participants affected / at risk     3/232 (1.29%)     1/118 (0.85%)  
# events     3     1  
B-cell lymphoma † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Basal cell carcinoma † 1    
# participants affected / at risk     5/232 (2.16%)     3/118 (2.54%)  
# events     8     3  
Bowen's disease † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Colon cancer † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Colon cancer metastatic † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Colorectal cancer † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Colorectal cancer metastatic † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Colorectal cancer recurrent † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Diffuse large B-cell lymphoma † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Hodgkin's disease † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Kaposi's sarcoma AIDS related † 1    
# participants affected / at risk     4/232 (1.72%)     0/118 (0.00%)  
# events     4     0  
Lip neoplasm malignant stage unspecified † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Lung neoplasm malignant † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Lymphoma † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Non-Hodgkin's lymphoma † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Oral neoplasm † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Rectal cancer † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Skin cancer † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Squamous cell carcinoma † 1    
# participants affected / at risk     2/232 (0.86%)     3/118 (2.54%)  
# events     5     5  
Squamous cell carcinoma of skin † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
T-cell lymphoma † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Tongue neoplasm malignant stage unspecified † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Vulval cancer stage 0 † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Nervous system disorders      
Cerebral haemorrhage † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Cerebral infarction † 1    
# participants affected / at risk     1/232 (0.43%)     1/118 (0.85%)  
# events     1     1  
Cerebral ischaemia † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Cerebrovascular accident † 1    
# participants affected / at risk     2/232 (0.86%)     1/118 (0.85%)  
# events     3     1  
Convulsion † 1    
# participants affected / at risk     1/232 (0.43%)     2/118 (1.69%)  
# events     1     3  
Encephalitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Epilepsy † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     4  
Hydrocephalus † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Hypoaesthesia † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Ischaemic stroke † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Parkinsonism † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Poor quality sleep † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Psychomotor hyperactivity † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Syncope † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Psychiatric disorders      
Depression † 1    
# participants affected / at risk     0/232 (0.00%)     2/118 (1.69%)  
# events     0     3  
Disturbance in social behaviour † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Panic attack † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Psychotic disorder † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Substance abuse † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Suicide attempt † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Renal and urinary disorders      
Calculus urinary † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Focal segmental glomerulosclerosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Nephrolithiasis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Nephropathy † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Nephropathy toxic † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Nephrotic syndrome † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Proteinuria † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Renal failure † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Renal failure acute † 1    
# participants affected / at risk     2/232 (0.86%)     0/118 (0.00%)  
# events     2     0  
Renal tubular necrosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Reproductive system and breast disorders      
Benign prostatic hyperplasia † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Epididymal cyst † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Epididymitis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Gynaecomastia † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Oedema genital † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Ovarian necrosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Prostatitis † 1    
# participants affected / at risk     2/232 (0.86%)     1/118 (0.85%)  
# events     2     1  
Uterine prolapse † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Dyspnoea † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Haemoptysis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Hiccups † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Lung disorder † 1    
# participants affected / at risk     1/232 (0.43%)     1/118 (0.85%)  
# events     1     1  
Pneumonia aspiration † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Pneumothorax † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Pulmonary embolism † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Pulmonary hypertension † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Respiratory distress † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Skin and subcutaneous tissue disorders      
Hidradenitis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     3  
Rash † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Vascular disorders      
Deep vein thrombosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Hypotension † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Hypovolaemic shock † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Shock † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
Varicophlebitis † 1    
# participants affected / at risk     0/232 (0.00%)     1/118 (0.85%)  
# events     0     1  
Venous thrombosis † 1    
# participants affected / at risk     1/232 (0.43%)     0/118 (0.00%)  
# events     1     0  
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; 94 of 118 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:
Other Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00293267     History of Changes
Other Study ID Numbers: 0518-018, 2005_096
Study First Received: February 14, 2006
Results First Received: August 18, 2009
Last Updated: October 22, 2013
Health Authority: France: Ministry of Health