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A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults (SAILING)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by ViiV Healthcare.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01231516
First received: October 21, 2010
Last updated: March 20, 2014
Last verified: March 2014
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572
Drug: Raltegravir
Drug: GSK1349572 Placebo
Drug: Raltegravir Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1441 participants were screened; 724 were randomized. A total of 719 participants received at least 1 dose of study medication and comprised the intent-to-treat exposed (ITT-E) population. Four participants from one closed site were removed from the ITT-E population creating the modified ITT-E population with 715 participants.

Reporting Groups
  Description
DTG 50 mg OD Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
RAL 400 mg BID Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.

Participant Flow for 2 periods

Period 1:   48 Week Double-blind Phase
    DTG 50 mg OD   RAL 400 mg BID
STARTED   357   362 
COMPLETED   299   283 
NOT COMPLETED   58   79 
Adverse Event                4                11 
Lack of Efficacy                20                42 
Protocol Violation                9                6 
Met Protocol-Defined Stopping Criteria                5                3 
Lost to Follow-up                5                10 
Physician Decision                1                1 
Withdrawal by Subject                11                5 
Site Closed                3                1 

Period 2:   Open-label Phase
    DTG 50 mg OD   RAL 400 mg BID
STARTED   295 [1]   27 [2] 
Ongoing at the Time of Analysis   282   23 
COMPLETED   0   1 
NOT COMPLETED   295   26 
Lack of Efficacy                7                3 
Protocol Violation                2                0 
Lost to Follow-up                3                0 
Withdrawal by Subject                1                0 
Ongoing at the time of analysis                282                23 
[1] 4 participants completed the Double-blind Phase but did not enter the Open-label Phase.
[2] 256 participants completed the Double-blind Phase but 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 OD Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
RAL 400 mg BID Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
Total Total of all reporting groups

Baseline Measures
   DTG 50 mg OD   RAL 400 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 354   361   715 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 42.6  (10.45)   42.5  (9.81)   42.5  (10.13) 
[1] Baseline Characteristic data are reported for members of the modified Intent-To-Treat Exposed Population, all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.
Gender [1] 
[Units: Participants]
     
Female   107   123   230 
Male   247   238   485 
[1] Baseline Characteristic data are reported for members of the modified Intent-To-Treat Exposed Population, all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
African American/African Heritage   143   160   303 
American Indian or Alaska Native   10   17   27 
Asian-Central/South Asian Heritage   2   2   4 
Asian-East Asian Heritage   6   4   10 
Asian-South East Asian Heritage   1   0   1 
Native Hawaiian or Other Pacific Islander   1   0   1 
White-Arabic/North African Heritage   3   3   6 
White-White/Caucasian/European Heritage   175   172   347 
Mixed Race   12   2   14 
Unknown   1   1   2 
[1] Baseline Characteristic data are reported for members of the modified Intent-To-Treat Exposed Population, all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.


  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent INI Resistance at Time of Protocol Defined Virology Failure (PDVF)   [ Time Frame: Baseline until PDVF up to Week 48 ]

3.  Secondary:   Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48   [ Time Frame: Week 24, Week 48 ]

5.  Secondary:   Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48   [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Measure Description The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 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.
mITT-E Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each visit is indicated by "n=X, X".

Reporting Groups
  Description
DTG 50 mg OD Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
RAL 400 mg BID Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.

Measured Values
   DTG 50 mg OD   RAL 400 mg BID 
Participants Analyzed 
[Units: Participants]
 354   361 
Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
   
Absolute value, BL, n=354, 361   204.5 
 (88 to 368) 
 193.0 
 (96 to 365) 
Absolute value, Week 4, n=341, 351   266.0 
 (164 to 416) 
 253.0 
 (153 to 425) 
Absolute value, Week 8, n=338, 346   280.0 
 (179 to 423) 
 268.0 
 (163 to 445) 
Absolute value, Week 12, n=335, 345   296.0 
 (188 to 451) 
 289.0 
 (174 to 443) 
Absolute value, Week 16, n=327, 338   299.0 
 (179 to 462) 
 293.0 
 (186 to 460) 
Absolute value, Week 24, n=326, 326   334.5 
 (201 to 488) 
 326.5 
 (198 to 473) 
Absolute value, Week 32, n=309, 309   332.0 
 (229 to 482) 
 338.0 
 (215 to 484) 
Absolute value, Week 40, n=299, 292   376.0 
 (239 to 523) 
 349.0 
 (227 to 500) 
Absolute value, Week 48, n=294, 283   385.0 
 (244 to 565) 
 379.0 
 (250 to 521) 
Change from BL, Week 4, n=341, 351   53.0 
 (0 to 109) 
 45.0 
 (5 to 99) 
Change from BL, Week 8, n=338, 346   60.5 
 (15 to 117) 
 59.0 
 (12 to 124) 
Change from BL, Week 12, n=335, 345   74.0 
 (25 to 135) 
 75.0 
 (22 to 141) 
Change from BL, Week 16, n=327, 338   76.0 
 (20 to 156) 
 79.5 
 (28 to 158) 
Change from BL, Week 24, n=326, 326   99.0 
 (34 to 184) 
 93.0 
 (46 to 166) 
Change from BL, Week 32, n=309, 309   107.0 
 (49 to 188) 
 116.0 
 (52 to 173) 
Change from BL, Week 40, n=299, 292   125.0 
 (57 to 212) 
 117.5 
 (52 to 192) 
Change from BL, Week 48, n=294, 283   144.0 
 (73 to 242) 
 137.0 
 (67 to 224) 

No statistical analysis provided for Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48



6.  Secondary:   Number of Participants With Indicated Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions   [ Time Frame: From Baseline (Day 1) until Week 48 ]

7.  Secondary:   Number of Participants With the Indicated Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)   [ Time Frame: From Baseline until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study ]

8.  Secondary:   DTG PK Parameters Including Cmax, Cmin, C0, and C0_avg   [ Time Frame: Week 4, Week 24, and Week 48 ]

9.  Secondary:   DTG PK Parameters Including AUC(0-tau)   [ Time Frame: Week 4, Week 24, and Week 48 ]

10.  Other Pre-specified:   Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48   [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]


  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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