A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00293254
First received: February 15, 2006
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: August 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: raltegravir potassium
Drug: Comparator: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Phase 3; First Patient In: 08-Mar-2006; Last Patient Last Visit (LPLV) for Week 48: 31-Jul-2007; Extension Study LPLV Week 240: May 2011

53 sites (US, Brazil, Canada, Colombia, Mexico, and Puerto Rico).


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients failed prior antiretroviral therapy (HIV RNA >1000 copies/mL), and had documented resistance to at least one drug in each class of licensed oral antiretroviral therapy (Nucleoside Reverse Transcriptase inhibitors, Non-Nucleoside Reverse Transcriptase Inhibitors, and Protease Inhibitors). All patients must have met laboratory criteria.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Participant Flow for 4 periods

Period 1:   Primary Study - Double-Blind Week 0-48
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     232     119  
Treated     230     119  
Continuing in Double-Blind     177 [1]   55 [2]
COMPLETED     177     55  
NOT COMPLETED     55     64  
Never Treated                 2                 0  
Adverse Event                 2                 1  
Death                 5                 2  
Lack of Efficacy                 2                 2  
Lost to Follow-up                 3                 1  
Withdrawal by Subject                 5                 1  
Moved or trial terminated at site                 1                 0  
Entered OLPVF Phase                 35                 57  
[1] Excludes participants who entered the Open-Label Post-Virologic Failure (OLPVF) Phase
[2] Excludes participants who entered the OLPVF phase

Period 2:   Extension - Double-Blind Week 49-156
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     177     54 [1]
COMPLETED     120     25  
NOT COMPLETED     57     29  
Adverse Event                 4                 1  
Death                 4                 1  
Lack of Efficacy                 3                 4  
Lost to Follow-up                 3                 3  
Withdrawal by Subject                 12                 8  
Participant Moved/Site Stopped Trial                 6                 3  
Other Reason                 10                 2  
Entered OLPVF Phase                 15                 7  
[1] 1 of 55 participants who completed Week 48 did not enter the extension study.

Period 3:   Extension - Open-Label Week 157-240
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     120     19 [1]
COMPLETED     110     18  
NOT COMPLETED     10     1  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 0  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 2                 0  
Other Reason                 4                 0  
[1] 6 of 25 participants who completed the double-blind phase did not enter this open-label phase.

Period 4:   Open-Label Post Virologic Failure Phase
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
STARTED     50 [1]   64 [1]
COMPLETED     19     37  
NOT COMPLETED     31     27  
Adverse Event                 4                 7  
Lack of Efficacy                 16                 14  
Withdrawal by Subject                 6                 3  
Lost to Follow-up                 3                 0  
Participant Moved/Site Stopped Trial                 1                 1  
Other Reason                 1                 2  
[1] Number of participants who failed treatment and consented to enter the OLPVF phase



  Baseline Characteristics
  Hide 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
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.
Total Total of all reporting groups

Baseline Measures
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT     Total  
Number of Participants  
[units: participants]
  230     119     349  
Age  
[units: Years]
Mean ( Full Range )
  45.3  
  ( 16 to 67 )  
  46.5  
  ( 17 to 70 )  
  45.7  
  ( 16 to 70 )  
Gender  
[units: participants]
     
Female     20     12     32  
Male     210     107     317  
Race/Ethnicity, Customized  
[units: Participants]
     
White     127     77     204  
Black     47     21     68  
Asian     2     1     3  
Hispanic     47     18     65  
Native American     1     0     1  
Other     6     2     8  
Cluster of Differentiation 4 (CD4) Cell Count  
[units: cells/mm^3]
Mean ( Full Range )
  146  
  ( 1 to 757 )  
  163  
  ( 0 to 674 )  
  152  
  ( 0 to 757 )  
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA)  
[units: copies/mL]
Geometric Mean ( Full Range )
  49159  
  ( 200 to 750000 )  
  47850  
  ( 200 to 750000 )  
  48709  
  ( 200 to 750000 )  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16   [ Time Frame: 16 Weeks ]

Measure Type Primary
Measure Title Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
Measure Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
Time Frame 16 Weeks  
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.
No text entered.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  229     119  
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  77.3  
  ( 71.3 to 82.6 )  
  42.9  
  ( 33.8 to 52.3 )  

No statistical analysis provided for Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16



2.  Primary:   Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Primary
Measure Title Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
Measure Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
Time Frame 48 Weeks  
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.
No text entered.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  228     119  
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  71.1  
  ( 64.7 to 76.8 )  
  37.8  
  ( 29.1 to 47.2 )  

No statistical analysis provided for Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48



3.  Primary:   Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL   [ Time Frame: 156 Weeks ]

Measure Type Primary
Measure Title Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Measure Description Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
Time Frame 156 Weeks  
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.

The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.

Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.


Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  229     119  
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  50.2  
  ( 43.6 to 56.9 )  
  21.0  
  ( 14.1 to 29.4 )  

No statistical analysis provided for Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL



4.  Primary:   Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL   [ Time Frame: 240 Weeks ]

Measure Type Primary
Measure Title Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Measure Description Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
Time Frame 240 Weeks  
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.

The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.

Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.


Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo + OBT Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  230     119  
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  45.7  
  ( 39.1 to 52.3 )  
  13.4  
  ( 7.9 to 20.9 )  

No statistical analysis provided for Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL



5.  Secondary:   Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16   [ Time Frame: 16 Weeks ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Measure Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
Time Frame 16 Weeks  
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.
No text entered.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  229     119  
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  62.0  
  ( 55.4 to 68.3 )  
  36.1  
  ( 27.5 to 45.4 )  

No statistical analysis provided for Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16



6.  Secondary:   Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

Measure Type Secondary
Measure Title Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Measure Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
Time Frame 48 Weeks  
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.
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  228     119  
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  59.6  
  ( 53.0 to 66.1 )  
  34.5  
  ( 26.0 to 43.7 )  

No statistical analysis provided for Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48



7.  Secondary:   Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Measure Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
Time Frame 156 Weeks  
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.
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  229     119  
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  47.6  
  ( 41.0 to 54.3 )  
  17.6  
  ( 11.3 to 25.7 )  

No statistical analysis provided for Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL



8.  Secondary:   Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL   [ Time Frame: 240 Weeks ]

Measure Type Secondary
Measure Title Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Measure Description Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
Time Frame 240 Weeks  
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.
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo + OBT Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  230     119  
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL  
[units: Percentage of Participants]
Number ( 95% Confidence Interval )
  41.3  
  ( 34.9 to 48.0 )  
  13.4  
  ( 7.9 to 20.9 )  

No statistical analysis provided for Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL



9.  Secondary:   Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response   [ Time Frame: 156 Weeks ]

Measure Type Secondary
Measure Title Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
Measure Description For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).
Time Frame 156 Weeks  
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.
Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  230     119  
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response  
[units: Percentage of Participants]
  44.3     17.6  

No statistical analysis provided for Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response



10.  Secondary:   Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
Measure Description Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)
Time Frame Baseline and Week 16  
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.
Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  222     117  
Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16  
[units: HIV RNA (log10 copies/mL)]
Mean ( 95% Confidence Interval )
  -1.92  
  ( -2.05 to -1.78 )  
  -1.06  
  ( -1.26 to -0.86 )  

No statistical analysis provided for Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16



11.  Secondary:   Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Measure Description Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
Time Frame Baseline and Week 48  
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.
Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  216     114  
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48  
[units: HIV RNA (log10 copies/mL)]
Mean ( 95% Confidence Interval )
  -1.75  
  ( -1.90 to -1.59 )  
  -0.87  
  ( -1.08 to -0.67 )  

No statistical analysis provided for Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48



12.  Secondary:   Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)   [ Time Frame: Baseline and Week 156 ]

Measure Type Secondary
Measure Title Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Measure Description Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
Time Frame Baseline and Week 156  
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.
Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  189     102  
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)  
[units: HIV RNA (log10 copies/mL)]
Mean ( 95% Confidence Interval )
  -1.37  
  ( -1.55 to -1.20 )  
  -0.52  
  ( -0.71 to -0.33 )  

No statistical analysis provided for Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)



13.  Secondary:   Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)   [ Time Frame: Baseline and Week 240 ]

Measure Type Secondary
Measure Title Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Measure Description Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
Time Frame Baseline and Week 240  
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.

Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Participants with virologic failure after Week 16 = treatment failures


Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo + OBT Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  182     95  
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)  
[units: HIV RNA (log10 copies/mL)]
Mean ( 95% Confidence Interval )
  -1.31  
  ( -1.49 to -1.13 )  
  -0.41  
  ( -0.59 to -0.23 )  

No statistical analysis provided for Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)



14.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16   [ Time Frame: Baseline and Week 16 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Measure Description Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 16  
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.
Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  219     117  
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16  
[units: CD4 Cell Count (cells/mm^3)]
Mean ( 95% Confidence Interval )
  85.8  
  ( 72.7 to 99.0 )  
  39.9  
  ( 26.2 to 53.6 )  

No statistical analysis provided for Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16



15.  Secondary:   Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48   [ Time Frame: Baseline and Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Measure Description Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 48  
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.

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.


Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  217     114  
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48  
[units: CD4 Cell Count (cells/mm^3)]
Mean ( 95% Confidence Interval )
  98.4  
  ( 84.1 to 112.7 )  
  39.8  
  ( 23.5 to 56.1 )  

No statistical analysis provided for Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48



16.  Secondary:   Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)   [ Time Frame: Baseline and Week 156 ]

Measure Type Secondary
Measure Title Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
Measure Description Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 156  
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.

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.


Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT No text entered.
Placebo + OBT No text entered.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  189     101  
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)  
[units: CD4 Cell Count (cells/mm^3)]
Mean ( 95% Confidence Interval )
  157.2  
  ( 130.7 to 183.6 )  
  54.2  
  ( 30.0 to 78.3 )  

No statistical analysis provided for Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)



17.  Secondary:   Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)   [ Time Frame: Baseline and Week 240 ]

Measure Type Secondary
Measure Title Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Measure Description Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)
Time Frame Baseline and Week 240  
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.

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.


Reporting Groups
  Description
Raltegravir 400 mg b.i.d. + OBT Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
Placebo + OBT Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.

Measured Values
    Raltegravir 400 mg b.i.d. + OBT     Placebo + OBT  
Number of Participants Analyzed  
[units: participants]
  181     95  
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)  
[units: CD4 Cell Count (Cells/mm^3)]
Mean ( 95% Confidence Interval )
  172.1  
  ( 141.7 to 202.5 )  
  54.1  
  ( 27.1 to 81.0 )  

No statistical analysis provided for Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Adverse events are reported by original treatment group for the entire 240-week study, including double-blind, open-label, and OLPVF phases; 83 of 119 participants in the placebo group also received raltegravir in the open-label or OLPVF phase.


  More Information