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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)

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ClinicalTrials.gov Identifier: NCT01048671
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : February 14, 2014
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: ARV (non-raltegravir)

  Participant Flow

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
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

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
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

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

Measure Type Primary
Measure Title Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
Measure Description 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. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.
Time Frame Up to 25 months after start of raltegravir treatment  

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.
Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.

Reporting Groups
  Description
Antiretroviral Combination Therapy Including Raltegravir 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.

Measured Values
   Antiretroviral Combination Therapy Including Raltegravir 
Participants Analyzed   477 
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir 
[Units: Percentage of participants]
 		 
FTC/TDF + raltegravir   44.4 
3TC/ABC + raltegravir   14.0 
Other 2 NRTIs + raltegravir   1.3 
Mulitple (>=3 ) ARV therapies + raltegravir   15.7 
Protease inhibitor + raltegravir   8.8 
Other strategies (each <5%)   15.7 

No statistical analysis provided for Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir



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

Measure Type Primary
Measure Title Percentage of Participants Responding to Treatment: All Treated Participants
Measure Description Response to treatment was defined as a viral load <50 RNA copies/mL
Time Frame 24 months after start of raltegravir treatment  

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 with a viral load assessment available at 24 months were included in the 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 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.
All Participants 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.

Measured Values
   ARV naïve at Baseline   Suppressed at Baseline   Virological Failure at Baseline   All Participants 
Participants Analyzed   52   230   125   407 
Percentage of Participants Responding to Treatment: All Treated Participants 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 94.2 
 (87.9 to 100.6)  		 94.3 
 (91.4 to 97.3)  		 71.2 
 (63.3 to 79.1)  		 87.2 
 (84.0 to 90.5) 

No statistical analysis provided for Percentage of Participants Responding to Treatment: All Treated Participants



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 ]

Measure Type Primary
Measure Title Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
Measure Description Response to treatment was defined as a viral load <50 RNA copies/mL
Time Frame 24 months after start of raltegravir treatment  

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 with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the 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 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.
All Participants 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.

Measured Values
   ARV naïve at Baseline   Suppressed at Baseline   Virological Failure at Baseline   All Participants 
Participants Analyzed   39   194   94   327 
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24 
[Units: Percentage of participants]
Number (95% Confidence Interval) 		 94.9 
 (87.9 to 101.8)  		 95.4 
 (92.4 to 98.3)  		 77.7 
 (69.2 to 86.1)  		 90.2 
 (87.0 to 93.4) 

No statistical analysis provided for Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24



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 ]

Measure Type Primary
Measure Title Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
Measure Description No text entered.
Time Frame Baseline and 24 months after start of raltegravir treatment  

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 with a CD4 cell count available at 24 months were included in the 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 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.
All Participants 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.

Measured Values
   ARV naïve at Baseline   Suppressed at Baseline   Virological Failure at Baseline   All Participants 
Participants Analyzed   55   229   123   407 
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants 
[Units: Cells/mm^3]
Mean (95% Confidence Interval) 		 260.58 
 (208.75 to 312.41)  		 47.97 
 (19.57 to 76.36)  		 149.98 
 (113.71 to 186.26)  		 107.53 
 (85.80 to 129.29) 

No statistical analysis provided for Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants



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 ]

Measure Type Primary
Measure Title Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
Measure Description No text entered.
Time Frame Baseline and 24 months after start of raltegravir treatment  

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 with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the 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 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.
All Participants 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.

Measured Values
   ARV naïve at Baseline   Suppressed at Baseline   Virological Failure at Baseline   All Participants 
Participants Analyzed   39   194   91   324 
Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24 
[Units: Cells/mm^3]
Mean (95% Confidence Interval) 		 285.05 
 (219.96 to 350.15)  		 49.21 
 (16.38 to 82.03)  		 150.87 
 (110.88 to 190.86)  		 106.15 
 (80.87 to 131.43) 

No statistical analysis provided for Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24



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

Measure Type Secondary
Measure Title Number of Participants With at Least One Adverse Event
Measure Description An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor’s product whether or not related to the use of the product.
Time Frame Up to 25 months after start of raltegravir treatment  

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.
Participants enrolled and not excluded for a protocol violation were included in the analysis.

Reporting Groups
  Description
Antiretroviral Combination Therapy Including Raltegravir 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.

Measured Values
   Antiretroviral Combination Therapy Including Raltegravir 
Participants Analyzed   480 
Number of Participants With at Least One Adverse Event 
[Units: Participants]
 		 287 

No statistical analysis provided for Number of Participants With at Least One Adverse Event




  Serious Adverse Events


  Other Adverse Events


  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.


  More Information