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A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies
This study is ongoing, but not recruiting participants.
Study NCT00293267   Information provided by Merck
First Received: February 14, 2006   Last Updated: November 12, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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 III; First Patient In: 22-Mar-2006; Last Patient Last Visit for Week 48: 03-Aug-2007 63 sites (Australia, Belgium, Denmark, France, Germany, Italy, Peru, Portugal, Spain, Switzerland, Taiwan, and Thailand), 61 of which randomized patients.

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. Plus OBT No text entered.
Placebo Plus OBT No text entered.

Participant Flow:   Overall Study
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
STARTED   234     118  
      Treated               232                 118  
      Continuing in Double-Blind               193                 50  
COMPLETED   193[1]   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 Virological Failure Phase               33                 60  
[1] Does not include patients whom entered the open-label post virological



  Baseline Characteristics
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Reporting Groups
  Description
Raltegravir 400 mg b.i.d. Plus OBT No text entered.
Placebo Plus OBT No text entered.

Baseline Measures
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus 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:   Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16   [ 16 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in HIV RNA at Week 16   [ Baseline and Week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in HIV RNA at Week 48   [ Baseline and Week 48 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in CD4 Cell Count at Week 16   [ Baseline and Week 16 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Baseline and Week 48 ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Proportion of Patients Achieving HIV RNA <50 Copies/mL at Week 48   [ 48 weeks ]
  Show Outcome Measure 6


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Total, serious adverse events    
# participants affected 46   21  
Blood and lymphatic system disorders    
Haemolytic Anaemia   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Leukopenia   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Neutropenia   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Cardiac disorders    
Acute Coronary Syndrome   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Angina Pectoris   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Myocardial Infarction   * A
      # participants affected / at risk
2/232 (0.86%)  
1/118 (0.85%)  
Pericarditis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Ear and labyrinth disorders    
Hypoacusis   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Vertigo   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Endocrine disorders    
Hyperthyroidism   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Eye disorders    
Endophthalmitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Uveitis   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Gastrointestinal disorders    
Abdominal Pain   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Ascites   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Gastritis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Hernial Eventration   † A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Rectal Haemorrhage   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Rectal Stenosis   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Upper Gastrointestinal Haemorrhage   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Varices Oesophageal   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
General disorders    
Asthenia   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Malaise   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Multi-Organ Failure   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Oedema Peripheral   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Pyrexia   * A
      # participants affected / at risk
1/232 (0.43%)  
1/118 (0.85%)  
Hepatobiliary disorders    
Cholangitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Gallbladder Disorder   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Hepatitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Hepatitis Toxic   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Portal Hypertension   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Immune system disorders    
Drug Hypersensitivity   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Hypersensitivity   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Infections and infestations    
Appendicitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Bronchopneumonia   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Choriomeningitis Lymphocytic   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Cytomegalovirus Colitis   † A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Cytomegalovirus Hepatitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Cytomegalovirus Infection   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
End Stage AIDS   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Erythema Infectiosum   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Genital Herpes   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Giardiasis   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
HIV Infection   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Meningitis Cryptococcal   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Mycobacterial Infection   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Mycobacterium Avium Complex Infection   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Oesophageal Candidiasis   * A
      # participants affected / at risk
0/232 (0.00%)  
2/118 (1.69%)  
Oral Candidiasis   † A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Pneumonia   * A
      # participants affected / at risk
5/232 (2.16%)  
2/118 (1.69%)  
Pneumonia Pneumococcal   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Pseudomonal Sepsis   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Respiratory Tract Infection   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Septic Shock   * A
      # participants affected / at risk
2/232 (0.86%)  
1/118 (0.85%)  
Sinusitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Staphylococcal Bacteraemia   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Urosepsis   † A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Injury, poisoning and procedural complications    
Foot Fracture   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Humerus Fracture   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Incisional Hernia   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Intentional Overdose   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Lower Limb Fracture   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Overdose   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Post Procedural Haematuria   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Spinal Fracture   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Thoracic Vertebral Fracture   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Wrist Fracture   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Investigations    
Alanine aminotransferase increased   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Aspartate aminotransferase increased   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Absolute neutrophil count decreased   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Weight Decreased   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Metabolism and nutrition disorders    
Diabetes Mellitus   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Malnutrition   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Obesity   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Musculoskeletal and connective tissue disorders    
Intervertebral Disc Protrusion   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Musculoskeletal Pain   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Osteonecrosis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Osteoporotic Fracture   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Anal Cancer   * A
      # participants affected / at risk
1/232 (0.43%)  
1/118 (0.85%)  
B-Cell Lymphoma   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Basal Cell Carcinoma   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Bowen's Disease   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Kaposi's Sarcoma AIDS Related   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Rectal Cancer   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Squamous Cell Carcinoma   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
T-Cell Lymphoma   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Nervous system disorders    
Convulsion   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Encephalitis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Epilepsy   † A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Poor Quality Sleep   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Psychomotor Hyperactivity   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Psychiatric disorders    
Depression   * A
      # participants affected / at risk
0/232 (0.00%)  
2/118 (1.69%)  
Panic Attack   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Renal and urinary disorders    
Focal Glomerulosclerosis   † A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Nephrolithiasis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Nephropathy   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Nephropathy Toxic   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Nephrotic Syndrome   † A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Proteinuria   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Renal Failure Chronic   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Renal Tubular Necrosis   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Reproductive system and breast disorders    
Benign Prostatic Hyperplasia   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Gynaecomastia   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Oedema Genital   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Prostatitis   * A
      # participants affected / at risk
2/232 (0.86%)  
0/118 (0.00%)  
Respiratory, thoracic and mediastinal disorders    
Pulmonary Hypertension   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Respiratory Distress   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Vascular disorders    
Hypotension   † A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
Shock   * A
      # participants affected / at risk
1/232 (0.43%)  
0/118 (0.00%)  
Varicophlebitis   * A
      # participants affected / at risk
0/232 (0.00%)  
1/118 (0.85%)  
† Indicates events were collected by systematic assessment.
* Indicates events were collected by non-systematic assessment.
A Term from vocabulary, MedDRA 10.0


  Other Adverse Events
  Show Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372


Publications:
Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54.
Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65.


Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_096, MK0518-018
Study First Received: February 14, 2006
Results First Received: August 18, 2009
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00293267     History of Changes
Health Authority: France: Ministry of Health





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