Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00515827
First received: August 10, 2007
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: January 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir (MK-0518)
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Raltegravir Then Placebo (Arm A) 400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
Placebo Then Raltegravir (Arm B) Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.

Participant Flow for 2 periods

Period 1:   First Intervention (12 Weeks)
    Raltegravir Then Placebo (Arm A)     Placebo Then Raltegravir (Arm B)  
STARTED     27     26  
COMPLETED     26     25  
NOT COMPLETED     1     1  
Unwilling to adhere to study requirement                 1                 1  

Period 2:   Second Intervention (12 Weeks)
    Raltegravir Then Placebo (Arm A)     Placebo Then Raltegravir (Arm B)  
STARTED     26     25  
COMPLETED     25     25  
NOT COMPLETED     1     0  
Consent withdraw                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Raltegravir Then Placebo (Arm A) 400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
Placebo Then Raltegravir (Arm B) Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Raltegravir Then Placebo (Arm A)     Placebo Then Raltegravir (Arm B)     Total  
Number of Participants  
[units: participants]
  27     26     53  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     24     51  
>=65 years     0     2     2  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 7     49  ± 11     49  ± 8  
Gender  
[units: participants]
     
Female     3     2     5  
Male     24     24     48  
Region of Enrollment  
[units: participants]
     
United States     27     26     53  



  Outcome Measures
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1.  Primary:   HIV-1 RNA Level   [ Time Frame: At Weeks 10 and 12 ]

2.  Secondary:   Change in HIV-1 RNA Level   [ Time Frame: At pre-entry, entry, weeks 10 and 12 ]

3.  Secondary:   Change in Total CD4 Cell Count   [ Time Frame: At pre-entry, entry, and week 12 ]

4.  Secondary:   Change in Total CD8 Cell Count   [ Time Frame: At pre-entry, entry, and week 12 ]

5.  Secondary:   Change in CD4+/CD38+/HLA-DR+ Percent   [ Time Frame: At pre-entry, entry, and week 12 ]

6.  Secondary:   Change in CD8+/CD38+/HLA-DR+ Percent   [ Time Frame: At pre-entry, entry, and week 12 ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Change in CD8+/CD38+/HLA-DR+ Percent
Measure Description Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.
Time Frame At pre-entry, entry, and week 12  
Safety Issue No  

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.
All participants who stayed on study treatment and had not experienced virologic failures.

Reporting Groups
  Description
Raltegravir (Arm A) 400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
Placebo (Arm B) Placebo administered twice daily in addition to OBR from entry until Week 12

Measured Values
    Raltegravir (Arm A)     Placebo (Arm B)  
Number of Participants Analyzed  
[units: participants]
  20     23  
Change in CD8+/CD38+/HLA-DR+ Percent  
[units: % CD8 cells co-express CD38+ and HLA-DR+]
Median ( Inter-Quartile Range )
  -1  
  ( -2 to 2 )  
  0  
  ( -2 to 5 )  

No statistical analysis provided for Change in CD8+/CD38+/HLA-DR+ Percent



7.  Secondary:   Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12   [ Time Frame: From first day of treatment to week 12 ]

8.  Secondary:   Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24   [ Time Frame: From week 12 to week 24 ]

9.  Secondary:   Number of Participants Who Discontinued Study Drug   [ Time Frame: From first day of treatment to week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics for AIDS Research, Harvard School of Public Health
phone: 617-432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00515827     History of Changes
Other Study ID Numbers: A5244, 10440, ACTG A5244
Study First Received: August 10, 2007
Results First Received: January 25, 2011
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration