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A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily (SPRING-2)

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ClinicalTrials.gov Identifier: NCT01227824
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : June 23, 2014
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus I
Interventions: Drug: GSK1349572 (dolutegravir)
Drug: raltegravir
Other: GSK1349572 Placebo
Other: ABC/3TC
Other: TDF/FTC
Other: raltegravir 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
This was a randomized, parallel group, non-inferiority study to demonstrate the antiviral activity of Dolutegravir. Participants were enrolled from 9 countries. Participants in Dolutegravir arm who completed 96 Weeks double-blind phase continued to receive Dolutegravir in open-label phase, until dolutegravir was locally available commercially.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 1035 participants were screened; 827 participants were randomized, and 822 participants entered the treatment period. Of the 5 participants who were randomized but not treated with investigational product, 4 withdrew consent and 1 was randomized in error. 338 participants were enrolled in open label phase to receive Dolutegravir.

Reporting Groups
  Description
DTG 50 mg Once a Day Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
RTG 400 mg BID Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
DTG 50 mg Once a Day (Open-label) Participants who successfully completed 96 weeks of double blind phase continued to receive DTG 50 mg once a day during open label phase, until dolutegravir was locally available commercially. Participants received DTG 50 mg once a day in combination with NRTI therapy, with either ABC/3TC or TDF/FTC.

Participant Flow for 2 periods

Period 1:   Double-blind Phase: 96 Weeks Duration
    DTG 50 mg Once a Day   RTG 400 mg BID   DTG 50 mg Once a Day (Open-label)
STARTED   411   411   0 
COMPLETED   304   332   0 
NOT COMPLETED   107   79   0 
Adverse Event                12                7                0 
Lack of Efficacy                22                25                0 
Protocol Violation                18                16                0 
Met Protocol-defined Stopping Criteria                6                3                0 
Study Closed/Terminated                6                4                0 
Lost to Follow-up                22                10                0 
Withdrawal by Subject                18                14                0 
Physician Decision                3                0                0 

Period 2:   Open-label Phase: Median of 1267 Days
    DTG 50 mg Once a Day   RTG 400 mg BID   DTG 50 mg Once a Day (Open-label)
STARTED   0   0   338 [1] 
COMPLETED   0   0   294 
NOT COMPLETED   0   0   44 
Adverse Event                0                0                4 
Lack of Efficacy                0                0                5 
Protocol Violation                0                0                5 
Met Protocol-defined Stopping Criteria                0                0                4 
Lost to Follow-up                0                0                15 
Withdrawal by Subject                0                0                8 
Physician Decision                0                0                3 
[1] 338 participants continued into the Open-label phase on completing the Double-blind 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
DTG 50 mg Once a Day Participants received DTG 50 mg once a day in combination with NRTI therapy, either with ABC/3TC or TDF)/FTC. Participants were given the opportunity to receive DTG 50 mg once a day during an Open-label Phase of the study.
RTG 400 mg BID Participants received RTG 400 mg BID in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
Total Total of all reporting groups

Baseline Measures
   DTG 50 mg Once a Day   RTG 400 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 411   411   822 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (9.19)   36.6  (10.02)   37.0  (9.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      63  15.3%      56  13.6%      119  14.5% 
Male      348  84.7%      355  86.4%      703  85.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
African American/African Heritage (Her)   49   39   88 
American Indian or Alaska Native   7   9   16 
Central/South Asian Her   2   0   2 
Japanese/East Asian Her/South East Asian Her   4   10   14 
Native Hawaiian or other Pacific Islander   2   0   2 
White   346   352   698 
African American/African Her and Asian and White   1   0   1 
Asian and White   0   1   1 


  Outcome Measures

1.  Primary:   Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48   [ Time Frame: Baseline up to Week 48 ]

2.  Secondary:   Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.   [ Time Frame: Week 48 and Week 96 ]

3.  Secondary:   Number of Participants With Plasma HIV-1 RNA <50 c/mL   [ Time Frame: Week 96 ]

4.  Secondary:   Number of Participants With Plasma HIV-1 RNA <400 c/mL   [ Time Frame: Week 48 and Week 96 ]

5.  Secondary:   Change From Baseline in Plasma HIV-1 RNA Over Time   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96 ]

6.  Secondary:   Absolute Values in Plasma HIV-1 RNA Over Time   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96 ]

7.  Secondary:   Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96 ]

8.  Secondary:   Absolute Values in CD4+ Cell Counts Over Time   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96 ]

9.  Secondary:   Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences   [ Time Frame: From Baseline until Week 96 ]

10.  Secondary:   Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)   [ Time Frame: From Baseline until Week 96 ]

11.  Secondary:   Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG   [ Time Frame: Week 4, Week 24, and Week 48 ]

12.  Secondary:   Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG   [ Time Frame: Week 4, Week 24, and Week 48 ]


  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
No text entered.


  More Information

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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01227824     History of Changes
Other Study ID Numbers: 113086
First Submitted: October 14, 2010
First Posted: October 25, 2010
Results First Submitted: August 15, 2013
Results First Posted: June 23, 2014
Last Update Posted: January 16, 2018