Full Text View
Tabular View
Study Results
Related Studies
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

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

Frequency Threshold
Threshold above which other adverse events are reported   2%  

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)

Other Adverse Events
  Raltegravir 400 mg b.i.d. Plus OBT Placebo Plus OBT
Total, other (not including serious) adverse events    
# participants affected 205   106  
Blood and lymphatic system disorders    
Anaemia   * A
      # participants affected / at risk
6/230 (2.61%)  
5/119 (4.20%)  
Lymphadenopathy   * A
      # participants affected / at risk
10/230 (4.35%)  
3/119 (2.52%)  
Neutropenia   * A
      # participants affected / at risk
0/230 (0.00%)  
3/119 (2.52%)  
Eye disorders    
Conjunctivitis   * A
      # participants affected / at risk
7/230 (3.04%)  
1/119 (0.84%)  
Gastrointestinal disorders    
Abdominal Discomfort   * A
      # participants affected / at risk
3/230 (1.30%)  
4/119 (3.36%)  
Abdominal Distension   * A
      # participants affected / at risk
11/230 (4.78%)  
2/119 (1.68%)  
Abdominal Pain   * A
      # participants affected / at risk
17/230 (7.39%)  
5/119 (4.20%)  
Abdominal Pain Upper   * A
      # participants affected / at risk
8/230 (3.48%)  
6/119 (5.04%)  
Aphthous Stomatitis   * A
      # participants affected / at risk
2/230 (0.87%)  
3/119 (2.52%)  
Constipation   * A
      # participants affected / at risk
9/230 (3.91%)  
0/119 (0.00%)  
Diarrhoea   * A
      # participants affected / at risk
44/230 (19.13%)  
22/119 (18.49%)  
Dry Mouth   * A
      # participants affected / at risk
1/230 (0.43%)  
3/119 (2.52%)  
Dyspepsia   * A
      # participants affected / at risk
6/230 (2.61%)  
0/119 (0.00%)  
Flatulence   * A
      # participants affected / at risk
14/230 (6.09%)  
3/119 (2.52%)  
Haemorrhoids   * A
      # participants affected / at risk
3/230 (1.30%)  
3/119 (2.52%)  
Nausea   † A
      # participants affected / at risk
33/230 (14.35%)  
21/119 (17.65%)  
Vomiting   * A
      # participants affected / at risk
18/230 (7.83%)  
10/119 (8.40%)  
General disorders    
Asthenia   * A
      # participants affected / at risk
7/230 (3.04%)  
1/119 (0.84%)  
Fatigue   * A
      # participants affected / at risk
33/230 (14.35%)  
10/119 (8.40%)  
Injection Site Reaction   * A
      # participants affected / at risk
31/230 (13.48%)  
11/119 (9.24%)  
Oedema Peripheral   * A
      # participants affected / at risk
4/230 (1.74%)  
5/119 (4.20%)  
Pyrexia   * A
      # participants affected / at risk
15/230 (6.52%)  
15/119 (12.61%)  
Hepatobiliary disorders    
Hepatomegaly   * A
      # participants affected / at risk
0/230 (0.00%)  
3/119 (2.52%)  
Immune system disorders    
Seasonal Allergy   * A
      # participants affected / at risk
6/230 (2.61%)  
0/119 (0.00%)  
Infections and infestations    
Anogenital Warts   * A
      # participants affected / at risk
10/230 (4.35%)  
1/119 (0.84%)  
Bronchitis   * A
      # participants affected / at risk
11/230 (4.78%)  
7/119 (5.88%)  
Cellulitis   * A
      # participants affected / at risk
8/230 (3.48%)  
4/119 (3.36%)  
Ear Infection   * A
      # participants affected / at risk
1/230 (0.43%)  
3/119 (2.52%)  
Folliculitis   * A
      # participants affected / at risk
7/230 (3.04%)  
1/119 (0.84%)  
Furuncle   * A
      # participants affected / at risk
2/230 (0.87%)  
3/119 (2.52%)  
Gastroenteritis   * A
      # participants affected / at risk
6/230 (2.61%)  
2/119 (1.68%)  
Genital Herpes   * A
      # participants affected / at risk
5/230 (2.17%)  
2/119 (1.68%)  
Herpes Zoster   * A
      # participants affected / at risk
13/230 (5.65%)  
1/119 (0.84%)  
Influenza   * A
      # participants affected / at risk
8/230 (3.48%)  
5/119 (4.20%)  
Nasopharyngitis   * A
      # participants affected / at risk
15/230 (6.52%)  
6/119 (5.04%)  
Oral Candidiasis   * A
      # participants affected / at risk
3/230 (1.30%)  
9/119 (7.56%)  
Papilloma Viral Infection   * A
      # participants affected / at risk
6/230 (2.61%)  
1/119 (0.84%)  
Pneumonia   * A
      # participants affected / at risk
4/230 (1.74%)  
3/119 (2.52%)  
Sinusitis   † A
      # participants affected / at risk
12/230 (5.22%)  
5/119 (4.20%)  
Upper Respiratory Tract Infection   * A
      # participants affected / at risk
30/230 (13.04%)  
15/119 (12.61%)  
Urinary Tract Infection   * A
      # participants affected / at risk
2/230 (0.87%)  
5/119 (4.20%)  
Injury, poisoning and procedural complications    
Contusion   * A
      # participants affected / at risk
5/230 (2.17%)  
1/119 (0.84%)  
Investigations    
Alanine aminotransferase increased   * A
      # participants affected / at risk
11/230 (4.78%)  
3/119 (2.52%)  
Aspartate aminotransferase increased   * A
      # participants affected / at risk
10/230 (4.35%)  
3/119 (2.52%)  
Blood cholesterol increased   † A
      # participants affected / at risk
3/230 (1.30%)  
5/119 (4.20%)  
Blood creatinine increased   * A
      # participants affected / at risk
9/230 (3.91%)  
4/119 (3.36%)  
Blood glucose increased   * A
      # participants affected / at risk
7/230 (3.04%)  
1/119 (0.84%)  
Blood phosphorus decreased   * A
      # participants affected / at risk
1/230 (0.43%)  
3/119 (2.52%)  
Blood triglycerides increased   * A
      # participants affected / at risk
8/230 (3.48%)  
6/119 (5.04%)  
Creatine phosphokinase increased   * A
      # participants affected / at risk
10/230 (4.35%)  
2/119 (1.68%)  
Lipase increased   * A
      # participants affected / at risk
5/230 (2.17%)  
1/119 (0.84%)  
Absolute neutrophil count decreased   * A
      # participants affected / at risk
2/230 (0.87%)  
3/119 (2.52%)  
Weight Decreased   * A
      # participants affected / at risk
6/230 (2.61%)  
2/119 (1.68%)  
Anorexia   * A
      # participants affected / at risk
3/230 (1.30%)  
3/119 (2.52%)  
Decreased Appetite   * A
      # participants affected / at risk
7/230 (3.04%)  
3/119 (2.52%)  
Arthralgia   * A
      # participants affected / at risk
9/230 (3.91%)  
6/119 (5.04%)  
Back Pain   * A
      # participants affected / at risk
8/230 (3.48%)  
5/119 (4.20%)  
Muscle Spasms   * A
      # participants affected / at risk
4/230 (1.74%)  
3/119 (2.52%)  
Musculoskeletal Pain   * A
      # participants affected / at risk
5/230 (2.17%)  
0/119 (0.00%)  
Myalgia   * A
      # participants affected / at risk
6/230 (2.61%)  
6/119 (5.04%)  
Musculoskeletal and connective tissue disorders    
Pain In Extremity   * A
      # participants affected / at risk
12/230 (5.22%)  
4/119 (3.36%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Skin Papilloma   * A
      # participants affected / at risk
10/230 (4.35%)  
4/119 (3.36%)  
Nervous system disorders    
Dizziness   * A
      # participants affected / at risk
15/230 (6.52%)  
5/119 (4.20%)  
Headache   * A
      # participants affected / at risk
30/230 (13.04%)  
11/119 (9.24%)  
Neuropathy   * A
      # participants affected / at risk
4/230 (1.74%)  
3/119 (2.52%)  
Neuropathy Peripheral   * A
      # participants affected / at risk
6/230 (2.61%)  
2/119 (1.68%)  
Paraesthesia   * A
      # participants affected / at risk
5/230 (2.17%)  
4/119 (3.36%)  
Psychiatric disorders    
Anxiety   * A
      # participants affected / at risk
4/230 (1.74%)  
3/119 (2.52%)  
Depression   * A
      # participants affected / at risk
9/230 (3.91%)  
4/119 (3.36%)  
Insomnia   * A
      # participants affected / at risk
11/230 (4.78%)  
3/119 (2.52%)  
Renal and urinary disorders    
Nephrolithiasis   * A
      # participants affected / at risk
2/230 (0.87%)  
3/119 (2.52%)  
Respiratory, thoracic and mediastinal disorders    
Cough   * A
      # participants affected / at risk
14/230 (6.09%)  
5/119 (4.20%)  
Dyspnoea   * A
      # participants affected / at risk
1/230 (0.43%)  
3/119 (2.52%)  
Nasal Congestion   * A
      # participants affected / at risk
5/230 (2.17%)  
1/119 (0.84%)  
Pharyngolaryngeal Pain   * A
      # participants affected / at risk
9/230 (3.91%)  
6/119 (5.04%)  
Sinus Congestion   * A
      # participants affected / at risk
3/230 (1.30%)  
5/119 (4.20%)  
Skin and subcutaneous tissue disorders    
Acne   * A
      # participants affected / at risk
5/230 (2.17%)  
0/119 (0.00%)  
Dermal Cyst   * A
      # participants affected / at risk
1/230 (0.43%)  
3/119 (2.52%)  
Dry Skin   * A
      # participants affected / at risk
2/230 (0.87%)  
4/119 (3.36%)  
Eczema   * A
      # participants affected / at risk
2/230 (0.87%)  
4/119 (3.36%)  
Night Sweats   * A
      # participants affected / at risk
9/230 (3.91%)  
3/119 (2.52%)  
Pruritus   * A
      # participants affected / at risk
4/230 (1.74%)  
3/119 (2.52%)  
Rash   * A
      # participants affected / at risk
16/230 (6.96%)  
3/119 (2.52%)  
Skin Lesion   * A
      # participants affected / at risk
5/230 (2.17%)  
0/119 (0.00%)  
Vascular disorders    
Haematoma   * A
      # participants affected / at risk
2/230 (0.87%)  
3/119 (2.52%)  
Hypertension   * A
      # participants affected / at risk
6/230 (2.61%)  
2/119 (1.68%)  
† Indicates events were collected by systematic assessment.
* Indicates events were collected by non-systematic assessment.
A Term from vocabulary, MedDRA 10.0


  More Information
  Hide More Information

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





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services