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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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  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
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1.  Primary:   Proportion of Patients Achieving HIV RNA <400 Copies/mL at Week 16   [ 16 Weeks ]

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

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

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

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

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


  Serious Adverse Events
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  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:

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