A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00764946
First received: October 1, 2008
Last updated: October 22, 2013
Last verified: October 2013
Results First Received: February 13, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus
Intervention: Drug: Comparator: 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
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Reporting Groups
  Description
Participants Failing Current Therapy Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
Participants Intolerant to Current Therapy Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
Participants Treatment Naive Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.

Participant Flow:   Overall Study
    Participants Failing Current Therapy     Participants Intolerant to Current Therapy     Participants Treatment Naive  
STARTED     98     89     22  
TREATED     97     88     21  
COMPLETED     85     72     18  
NOT COMPLETED     13     17     4  
Lack of Efficacy                 1                 0                 0  
Lost to Follow-up                 3                 4                 0  
Physician Decision                 2                 4                 0  
Adverse Event                 3                 2                 1  
Withdrawal by Subject                 3                 6                 2  
Never Treated                 1                 1                 1  



  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
Participants Failing Current Therapy Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
Participants Intolerant to Current Therapy Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
Participants Treatment Naive Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
Total Total of all reporting groups

Baseline Measures
    Participants Failing Current Therapy     Participants Intolerant to Current Therapy     Participants Treatment Naive     Total  
Number of Participants  
[units: participants]
  97     88     21     206  
Age [1]
[units: years]
Mean ± Standard Deviation
  44.0  ± 9.2     46.9  ± 9.0     38.5  ± 10.1     44.7  ± 9.5  
Gender [1]
[units: participants]
       
Female     46     44     7     97  
Male     51     44     14     109  
Race [1]
[units: Participants]
       
Black     70     69     14     153  
Non-Black     27     19     7     53  
[1] Participants who did not receive treatment are excluded from this measure.



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Primary:   Number of Participants With One or More Adverse Events   [ Time Frame: Week 48 ]

3.  Primary:   Number of Participants Who Discontinued Due to an Adverse Event   [ Time Frame: Week 48 ]

4.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48   [ Time Frame: Week 48 ]

5.  Secondary:   Mean Change From Baseline to Week 48 in HIV RNA   [ Time Frame: Baseline and Week 48 ]

6.  Secondary:   Mean Change From Baseline to Week 48 in CD4 Cell Count   [ Time Frame: Baseline and Week 48 ]

7.  Secondary:   Number of Participants Without Loss of Virologic Response   [ Time Frame: Week 48 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharpe & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00764946     History of Changes
Other Study ID Numbers: 0518-055, 2008_555
Study First Received: October 1, 2008
Results First Received: February 13, 2012
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration