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

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ClinicalTrials.gov Identifier: NCT00293254
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : September 30, 2009
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: raltegravir potassium
Drug: Comparator: placebo

  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

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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      20   8.7%      12  10.1%      32   9.2% 
Male      210  91.3%      107  89.9%      317  90.8% 
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

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

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

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  

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 
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 ]
  Show Outcome Measure 3

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  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
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