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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01227824
First received: October 14, 2010
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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 who met eligibility criteria at Screening were then randomized to a 96-week treatment period. A total of 1035 participants were screened; 827 participants were randomized, and 822 participants entered the treatment period.

Reporting Groups
  Description
DTG 50 mg OD Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) 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 OD 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.

Participant Flow for 2 periods

Period 1:   Double-blind Phase
    DTG 50 mg OD     RTG 400 mg BID  
STARTED     411     411  
COMPLETED     349     332  
NOT COMPLETED     62     79  
Adverse Event                 8                 7  
Lack of Efficacy                 17                 25  
Protocol Violation                 13                 16  
Met Protocol-defined Stopping Criteria                 2                 3  
Study Closed/Terminated                 6                 4  
Lost to Follow-up                 6                 10  
Withdrawal by Subject                 10                 14  

Period 2:   Open-label Phase
    DTG 50 mg OD     RTG 400 mg BID  
STARTED     338 [1]   0  
Ongoing     337     0  
COMPLETED     0     0  
NOT COMPLETED     338     0  
Protocol Violation                 1                 0  
Ongoing                 337                 0  
[1] Eleven participant completing the Double-blind Phase did not continue into 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 a day (OD) 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 OD 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.
Total Total of all reporting groups

Baseline Measures
    DTG 50 mg OD     RTG 400 mg BID     Total  
Number of Participants  
[units: participants]
  411     411     822  
Age  
[units: Years]
Mean ± Standard Deviation
  37.3  ± 9.19     36.6  ± 10.02     37.0  ± 9.61  
Gender  
[units: Participants]
     
Female     63     56     119  
Male     348     355     703  
Race/Ethnicity, Customized  
[units: 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 & Asian & White     1     0     1  
Asian & White     0     1     1  



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1RNA <50 Copies (c)/Milliliter (mL) Through Week 48.   [ Time Frame: Baseline 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, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96 ]

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

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

8.  Secondary:   Absolute Values in CD4+ Cell Counts Over Time   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 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:   AUC(0-tau) of DTG   [ Time Frame: Week 4, Week 24, and Week 48 ]

12.  Secondary:   Cmax and Ctau of DTG   [ Time Frame: Week 4, Week 24, and Week 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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  More Information
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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


Publications:
Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01227824     History of Changes
Other Study ID Numbers: 113086
Study First Received: October 14, 2010
Results First Received: August 15, 2013
Last Updated: June 19, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
Australia: Human Research Ethics Committee
Russia: Federal Service of Surveillance in Healthcare and Social development of Russian federation
United States: Food and Drug Administration
Russia: Russian Ministry of Health
Canada: Health Canada
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Europe: European Medicines Agency