Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir (VIKING-4)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01568892
First received: March 29, 2012
Last updated: January 2, 2014
Last verified: December 2013
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: dolutegravir 50 mg twice daily
Drug: dolutegravir placebo twice daily
Drug: Open-label dolutegravir 50mg twice daily

  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
Participants (par.) meeting eligibility criteria at screening entered a 7-day randomized, double-blind, placebo-controlled phase. At Day 8, all par. entered an open-label phase and continued to receive dolutegravir with an optimized background regimen. A total of 75 par. were screened; 45 par. were screen failures, and 30 par. were randomized.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Participant Flow for 2 periods

Period 1:   Double-blind Phase
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
STARTED     14     16  
COMPLETED     14     16  
NOT COMPLETED     0     0  

Period 2:   Open-label Phase
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
STARTED     13 [1]   16  
Ongoing     12     15  
COMPLETED     0     0  
NOT COMPLETED     13     16  
Adverse Event                 1                 0  
Lack of Efficacy                 0                 1  
Ongoing                 12                 15  
[1] One participant completing the DB Phase withdrew on Day 8 and did not enter the Open-label Phase.



  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
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Total Total of all reporting groups

Baseline Measures
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase     Total  
Number of Participants  
[units: participants]
  14     16     30  
Age  
[units: Years]
Mean ± Standard Deviation
  47.5  ± 11.56     48.6  ± 8.85     48.1  ± 10.04  
Gender  
[units: Participants]
     
Female     2     4     6  
Male     12     12     24  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     8     8     16  
American Indian or Alaska Native     0     1     1  
White - Arabic/North African Heritage     1     0     1  
White - White/Caucasian/European Heritage     4     7     11  
Missing: None of the Available Races Applied     1     0     1  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8   [ Time Frame: Baseline and Day 8 ]

Measure Type Primary
Measure Title Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.
Time Frame Baseline and Day 8  
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.
ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  13     16  
Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8  
[units: Log 10 copies per milliliter (c/mL)]
Least Squares Mean ± Standard Error
  -1.06  ± 0.168     0.10  ± 0.183  


Statistical Analysis 1 for Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.001
Mean Difference (Final Values) [4] -1.16
95% Confidence Interval ( -1.52 to -0.80 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Absolute Values in Plasma HIV-1 RNA Over Time   [ Time Frame: Baseline, Day 8, Day 28, and Week 8 ]

Measure Type Secondary
Measure Title Absolute Values in Plasma HIV-1 RNA Over Time
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, and Week 24. Too few participants reached post-Week 8 study visits, hence only data through Week 8 are presented.
Time Frame Baseline, Day 8, Day 28, and Week 8  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Absolute Values in Plasma HIV-1 RNA Over Time  
[units: Log10 c/mL]
Mean ± Standard Deviation
   
Baseline, n=14, 16     4.02  ± 0.940     4.42  ± 0.760  
Day 8, n=14, 16     2.95  ± 0.790     4.39  ± 0.844  
Day 28, n=13, 16     2.14  ± 0.772     2.30  ± 1.054  
Week 8, n=9, 14     2.52  ± 0.854     2.07  ± 0.937  

No statistical analysis provided for Absolute Values in Plasma HIV-1 RNA Over Time



3.  Secondary:   Mean Change From Baseline in Plasma HIV-1 RNA Over Time   [ Time Frame: Baseline, Day 8, Day 28, and Week 8 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Plasma HIV-1 RNA Over Time
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, and Week 24. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Too few participants reached post-Week 8 study visits, hence only data through Week 8 are presented.
Time Frame Baseline, Day 8, Day 28, and Week 8  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Mean Change From Baseline in Plasma HIV-1 RNA Over Time  
[units: Log10 c/mL]
Mean ± Standard Deviation
   
Baseline, n=14, 16     4.02  ± 0.940     4.42  ± 0.760  
Day 8, n=14, 16     -1.07  ± 0.683     -0.03  ± 0.262  
Day 28, n=13, 16     -1.87  ± 0.898     -2.12  ± 1.111  
Week 8, n=9, 14     -2.04  ± 0.830     -2.37  ± 1.175  

No statistical analysis provided for Mean Change From Baseline in Plasma HIV-1 RNA Over Time



4.  Secondary:   Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time   [ Time Frame: Baseline, Day 8, Day 28, and Week 8 ]

Measure Type Secondary
Measure Title Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, and Week 8, using the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.
Time Frame Baseline, Day 8, Day 28, and Week 8  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time  
[units: participants]
   
Baseline, n=14, 16     0     0  
Day 8, n=14, 16     1     0  
Day 28, n=13, 16     6     6  
Week 8, n=9, 14     3     8  

No statistical analysis provided for Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time



5.  Secondary:   Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time   [ Time Frame: Baseline, Day 8, Day 28, and Week 8 ]

Measure Type Secondary
Measure Title Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time
Measure Description Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, and Week 8, using the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.
Time Frame Baseline, Day 8, Day 28, and Week 8  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time  
[units: participants]
   
Baseline, n=14, 16     2     0  
Day 8, n=14, 16     4     0  
Day 28, n=13, 16     9     12  
Week 8, n=9, 14     5     12  

No statistical analysis provided for Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time



6.  Secondary:   Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time   [ Time Frame: Baseline, Day 8, Day 28, and Week 8 ]

Measure Type Secondary
Measure Title Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time
Measure Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline, Day 8, Day 28, and Week 8.
Time Frame Baseline, Day 8, Day 28, and Week 8  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time  
[units: Cells per cubic millimeters]
Median ( Inter-Quartile Range )
   
Baseline, n=14, 16     163.5  
  ( 111.0 to 231.0 )  
  90.5  
  ( 46.0 to 267.5 )  
Day 8, n=14, 15     198.5  
  ( 154.0 to 239.0 )  
  102.0  
  ( 50.0 to 310.0 )  
Day 28, n=13, 16     174.0  
  ( 168.0 to 335.0 )  
  234.0  
  ( 114.5 to 303.5 )  
Week 8, n=9, 14     192.0  
  ( 71.0 to 221.0 )  
  215.0  
  ( 100.0 to 368.0 )  

No statistical analysis provided for Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time



7.  Secondary:   Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time   [ Time Frame: Baseline, Day 8, Day 28, and Week 8 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time
Measure Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline, Day 8, Day 28, and Week 8. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline, Day 8, Day 28, and Week 8  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time  
[units: Cells per cubic millimeters]
Median ( Inter-Quartile Range )
   
Baseline, n=14, 16     163.5  
  ( 111.0 to 231.0 )  
  90.5  
  ( 46.0 to 267.5 )  
Day 8, n=14, 15     7.0  
  ( 0.0 to 94.0 )  
  0.0  
  ( -12.0 to 24.0 )  
Day 28, n=13, 16     14.0  
  ( 6.0 to 68.0 )  
  68.5  
  ( 5.0 to 140.5 )  
Week 8, n=9, 14     32.0  
  ( 10.0 to 56.0 )  
  83.0  
  ( 3.0 to 126.0 )  

No statistical analysis provided for Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time



8.  Secondary:   Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts at Baseline and Day 28   [ Time Frame: Baseline and Day 28 ]

Measure Type Secondary
Measure Title Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts at Baseline and Day 28
Measure Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline and Day 28.
Time Frame Baseline and Day 28  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts at Baseline and Day 28  
[units: Cells per cubic millimeter]
Median ( Inter-Quartile Range )
   
Baseline, n=14, 16     896.0  
  ( 589.0 to 1689.0 )  
  808.5  
  ( 436.5 to 1221.0 )  
Day 28, n=13, 16     1135.0  
  ( 598.0 to 1741.0 )  
  973.0  
  ( 675.0 to 1322.0 )  

No statistical analysis provided for Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts at Baseline and Day 28



9.  Secondary:   Median Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Day 28   [ Time Frame: Baseline and Day 28 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Day 28
Measure Description Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline and Day 28. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Time Frame Baseline and Day 28  
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.
ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Median Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Day 28  
[units: Cells per cubic millimeter]
Median ( Inter-Quartile Range )
   
Cells per cubic millimeter     896.0  
  ( 589.0 to 1689.0 )  
  808.5  
  ( 436.5 to 1221.0 )  
Day 28, n=13, 16     227.0  
  ( -135.0 to 301.0 )  
  177.0  
  ( 51.0 to 278.5 )  

No statistical analysis provided for Median Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Day 28



10.  Secondary:   Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])   [ Time Frame: From the day of the first dose of study drug until early withdrawal or the Day 8 analysis cut-off date (average of 14 study weeks) ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])
Measure Description The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Time Frame From the day of the first dose of study drug until early withdrawal or the Day 8 analysis cut-off date (average of 14 study 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.
ITT-E Population

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])  
[units: participants]
   
From CDC Class A to CDC Class C     0     0  
From CDC Class B to CDC Class C     0     0  
From CDC Class C to new CDC Class C     0     0  
From CDC Class A, B, or C to Death     1     0  

No statistical analysis provided for Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])



11.  Secondary:   Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade   [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks) ]

Measure Type Secondary
Measure Title Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade
Measure Description An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Time Frame From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study 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.
Safety Population: all randomized participants who received at least one dose of study medication

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade  
[units: participants]
   
Grade 1     1     5  
Grade 2     6     2  
Grade 3     2     0  
Grade 4     1     1  

No statistical analysis provided for Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade



12.  Secondary:   Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade   [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks) ]

Measure Type Secondary
Measure Title Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade
Measure Description Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Time Frame From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study 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.
Safety Population

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade  
[units: participants]
   
Grade 1     4     5  
Grade 2     4     4  
Grade 3     0     2  
Grade 4     0     1  

No statistical analysis provided for Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade



13.  Secondary:   Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade   [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks) ]

Measure Type Secondary
Measure Title Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade
Measure Description Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Time Frame From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study 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.
Safety Population

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  14     16  
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade  
[units: participants]
   
Grade 1     2     1  
Grade 2     2     5  
Grade 3     0     1  
Grade 4     0     0  

No statistical analysis provided for Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade



14.  Secondary:   Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24   [ Time Frame: Day 8, Day 28, and Week 24 ]

Measure Type Secondary
Measure Title Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24
Measure Description Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24
Time Frame Day 8, Day 28, and Week 24  
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.
PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  11     13  
Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24  
[units: µg/mL]
Geometric Mean ( Geometric Coefficient of Variation )
   
Day 8 C0, n=10, 0     3.095  
  ( 47% )  
  NA  
  ( NA% ) [1]
Day 28 C0, n=8, 13     1.000  
  ( 199% )  
  1.980  
  ( 88% )  
Week 24 C0, n=1, 0     1.960  
  ( NA% ) [2]
  NA  
  ( NA% ) [1]
C0_avg, n=11, 13     1.751  
  ( 210% )  
  1.980  
  ( 88% )  
[1] No participants in this treatment group were analyzed at this time point.
[2] The dispersion measure could not be calculated because only one participant was analyzed in this treatment group at this time point.

No statistical analysis provided for Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24



15.  Secondary:   Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days) ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
Measure Description For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.
Time Frame From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days)  
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.
PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  1     2  
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance  
[units: participants]
   
Any integrase mutation     1     1  
L74L/M and N155N/H     1     0  
T97A     0     1  

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance



16.  Secondary:   Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance   [ Time Frame: From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days) ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance
Measure Description For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.
Time Frame From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days)  
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.
PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.

Reporting Groups
  Description
DTG 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.

Measured Values
    DTG 50 mg BID     Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase  
Number of Participants Analyzed  
[units: participants]
  1     2  
Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance  
[units: participants]
   
4-<8 fold increase in DTG FC     0     1  
>=8 fold increase in DTG FC     1     0  

No statistical analysis provided for Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance



17.  Secondary:   AUC(0-tau) of DTG   [ Time Frame: Day 8, Day 28, and Week 24 ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No

18.  Secondary:   Cmax of DTG   [ Time Frame: Day 8, Day 28, and Week 24 ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No


  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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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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01568892     History of Changes
Other Study ID Numbers: 116529
Study First Received: March 29, 2012
Results First Received: August 15, 2013
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board