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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 NCT00293254   Information provided by Merck
First Received: February 15, 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: Comparator: 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: 08-Mar-2006; Last Patient Last Visit for Week 48: 31-Jul-2007

53 sites (US, Brazil, Canada, Colombia, and Mexico).

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 Raltegravir 400 mg twice a day (b.i.d.) plus Optimized Background Therapy (OBT)
Placebo Plus OBT Placebo plus Optimized Background Therapy (OBT)

Participant Flow:   Overall Study
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
STARTED   232     119  
      Treated               230                 119  
COMPLETED   177     55  
NOT COMPLETED   55     64  
      Never Treated               2                 0  
      Adverse Event               1                 0  
      Death               6                 3  
      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 Post Virological Failure phase               35                 57  



  Baseline Characteristics
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Reporting Groups
  Description
Raltegravir 400 mg b.i.d. Plus OBT Raltegravir 400 mg twice a day (b.i.d.) plus Optimized Background Therapy (OBT)
Placebo Plus OBT Placebo plus Optimized Background Therapy (OBT)

Baseline Measures
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus 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 126 77 203
Black 48 21 69
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 ) 		48366
( 200 to 750000 )		 47850
( 200 to 750000 )		 48190
( 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   [ Week 48 ]
  Show Outcome Measure 6


  Serious Adverse Events
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Reporting Groups
  Description
Raltegravir 400 mg b.i.d. Plus OBT Raltegravir 400 mg twice a day (b.i.d.) plus Optimized Background Therapy (OBT)
Placebo Plus OBT Placebo plus Optimized Background Therapy (OBT)

Serious Adverse Events
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Total, serious adverse events    
# participants affected 36   24  
Blood and lymphatic system disorders    
Anaemia   † A
      # participants affected / at risk
3/230 (1.30%)  
0/119 (0.00%)  
Febrile Neutropenia   † A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Neutropenia   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Cardiac disorders    
Cardiac Failure Congestive   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Cardio-Respiratory Arrest   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Coronary Artery Disease   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Left Ventricular Dysfunction   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Mitral Valve Incompetence   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Myocardial Infarction   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Ventricular Tachycardia   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Gastrointestinal disorders    
Abdominal Pain   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Anal Fistula   † A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Diarrhoea   * A
      # participants affected / at risk
2/230 (0.87%)  
0/119 (0.00%)  
Ileitis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Lower Gastrointestinal Haemorrhage   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Nausea   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Pancreatitis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Small Intestinal Obstruction   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Vomiting   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Death   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
General disorders    
Asthenia   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Malaise   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Pyrexia   * A
      # participants affected / at risk
2/230 (0.87%)  
3/119 (2.52%)  
Immune system disorders    
Hypersensitivity   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Immune Reconstitution Syndrome   * A
      # participants affected / at risk
2/230 (0.87%)  
0/119 (0.00%)  
Infections and infestations    
AIDS Dementia Complex   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Abscess Bacterial   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Acinetobacter Bacteraemia   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Appendicitis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Aspergillosis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Atypical Mycobacterial Lymphadenitis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Bronchitis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Cellulitis   * A
      # participants affected / at risk
3/230 (1.30%)  
0/119 (0.00%)  
Clostridium Difficile Colitis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Cytomegalovirus Chorioretinitis   * A
      # participants affected / at risk
0/230 (0.00%)  
2/119 (1.68%)  
Cytomegalovirus Colitis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Endocarditis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Gastroenteritis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Gastroenteritis Cryptosporidial   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Gastroenteritis Salmonella   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Herpes Zoster Disseminated   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Infection   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Influenza   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Meningitis Cryptococcal   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Mycobacterium Avium Complex Infection   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Oesophageal Candidiasis   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Osteomyelitis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Otitis Media   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Pneumonia   * A
      # participants affected / at risk
4/230 (1.74%)  
3/119 (2.52%)  
Pyelonephritis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Retroviral Infection   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Salmonella Bacteraemia   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Sepsis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Sinusitis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Subcutaneous Abscess   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Tuberculosis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Urosepsis   † A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Viral Infection   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Injury, poisoning and procedural complications    
Accidental Overdose   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Hip Fracture   * A
      # participants affected / at risk
0/230 (0.00%)  
2/119 (1.68%)  
Intentional Overdose   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Post Procedural Haemorrhage   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Investigations    
Blood creatinine increased   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Metabolism and nutrition disorders    
Cachexia   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Dehydration   * A
      # participants affected / at risk
3/230 (1.30%)  
1/119 (0.84%)  
Failure To Thrive   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Hyperglycaemia   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Hypovolaemia   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Musculoskeletal and connective tissue disorders    
Bone Pain   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Osteonecrosis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Anal Cancer Stage 0   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Basal Cell Carcinoma   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Hepatic Neoplasm Malignant   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Lymphoma   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Metastatic Squamous Cell Carcinoma   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Rectal Cancer Stage 0   † A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Squamous Cell Carcinoma   * A
      # participants affected / at risk
3/230 (1.30%)  
1/119 (0.84%)  
Nervous system disorders    
Cerebral Infarction   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Convulsion   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Migraine   † A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Neuralgia   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Presyncope   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Syncope   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Psychiatric disorders    
Depression   * A
      # participants affected / at risk
2/230 (0.87%)  
0/119 (0.00%)  
Mental Status Changes   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Renal and urinary disorders    
Nephrolithiasis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Renal Failure   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Renal Failure Acute   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
Respiratory, thoracic and mediastinal disorders    
Asthma   † A
      # participants affected / at risk
2/230 (0.87%)  
0/119 (0.00%)  
Respiratory Failure   * A
      # participants affected / at risk
1/230 (0.43%)  
1/119 (0.84%)  
Vascular disorders    
Deep Vein Thrombosis   * A
      # participants affected / at risk
1/230 (0.43%)  
0/119 (0.00%)  
Venous Thrombosis   * A
      # participants affected / at risk
0/230 (0.00%)  
1/119 (0.84%)  
† 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
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  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_097, MK0518-019
Study First Received: February 15, 2006
Results First Received: August 20, 2009
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00293254     History of Changes
Health Authority: United States: Food and Drug Administration





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