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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01048671
First received: January 12, 2010
Last updated: June 23, 2014
Last verified: June 2014
Results First Received: 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
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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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 482 participants included in the trial, 2 were excluded from analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.

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 ribonucleic acid (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.
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.

Participant Flow:   Overall Study
    ARV naïve at Baseline     Suppressed at Baseline     Virological Failure at Baseline  
STARTED     66     264     152  
COMPLETED     66     263     151  
NOT COMPLETED     0     1     1  
Protocol Violation                 0                 1                 1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01048671     History of Changes
Other Study ID Numbers: 0518-138, MK0518-138
Study First Received: January 12, 2010
Results First Received: December 23, 2013
Last Updated: June 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)