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Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138) (RACING)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01048671
First Posted: January 14, 2010
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: December 23, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: ARV (non-raltegravir)

  Participant Flow


  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.
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Reporting Groups
  Description
ARV naïve at Baseline ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
Suppressed at Baseline Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
Virological Failure at Baseline Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
Total Total of all reporting groups

Baseline Measures
   ARV naïve at Baseline   Suppressed at Baseline   Virological Failure at Baseline   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   263   151   480 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.9  (12.0)   47.3  (10.1)   46.5  (10.4)   46.4  (10.6) 
Gender 
[Units: Participants]
       
Female   17   91   65   173 
Male   49   172   86   307 
Time Since Human Immunodeficiency Virus (HIV) Infection Diagnosis 
[Units: Years]
Mean (Standard Deviation)
 2.8  (4.7)   13.0  (7.0)   11.6  (7.5)   11.1  (7.7) 


  Outcome Measures
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1.  Primary:   Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir   [ Time Frame: Up to 25 months after start of raltegravir treatment ]

2.  Primary:   Percentage of Participants Responding to Treatment: All Treated Participants   [ Time Frame: 24 months after start of raltegravir treatment ]

3.  Primary:   Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24   [ Time Frame: 24 months after start of raltegravir treatment ]

4.  Primary:   Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants   [ Time Frame: Baseline and 24 months after start of raltegravir treatment ]

5.  Primary:   Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24   [ Time Frame: Baseline and 24 months after start of raltegravir treatment ]

6.  Secondary:   Number of Participants With at Least One Adverse Event   [ Time Frame: Up to 25 months after start of raltegravir treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01048671     History of Changes
Other Study ID Numbers: 0518-138
MK0518-138
First Submitted: January 12, 2010
First Posted: January 14, 2010
Results First Submitted: December 23, 2013
Results First Posted: February 14, 2014
Last Update Posted: October 30, 2015