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

This study is ongoing, but not recruiting participants.
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
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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


  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 ]

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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