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Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET) (SIGNET)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01231555
First Posted: November 1, 2010
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
Results First Submitted: August 28, 2017  
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
Interventions: Drug: GSK2248761 100 mg once daily
Drug: GSK2248761 200 mg once daily
Drug: Efavirenz 600 mg once 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
This study was conducted from 18 November 2010 to 04 July 2011. A total of 150 human immunodeficiency virus (HIV)-1 infected adult participants naïve to antiretroviral therapy (ART) were planned to be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment was terminated prematurely due to safety findings. At the time of enrollment termination, 23 participants were enrolled who continued into this study. At least 5 interim analyses were planned up to Week 48, however, the study was terminated prior to any of these analyses being conducted.

Reporting Groups
  Description
GSK2248761 100 mg Once Daily Eligible participants were planned to receive oral GSK2248761 100 milligrams (mg) capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 mg once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received antiretroviral therapy (ART) of Tenofovir disoproxil fumarate/ Emtricitabine (TDF/FTC) 300 mg/200 mg or Abacavir/ Lamivudine (ABC/3TC) 600 mg/300 mg along with the study drug.
GSK2248761 200 mg Once Daily Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
EFV 600 mg Once Daily Eligible participants were planned to receive oral Efavirenz (EFV) 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.

Participant Flow:   Overall Study
    GSK2248761 100 mg Once Daily   GSK2248761 200 mg Once Daily   EFV 600 mg Once Daily
STARTED   8   7   8 
COMPLETED   0   0   0 
NOT COMPLETED   8   7   8 
Study terminated                8                5                8 
Withdrawal by Subject                0                2                0 



  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
GSK2248761 100 mg Once Daily Eligible participants were planned to receive oral GSK2248761 100 mg capsule once daily and matching GSK2248761 Placebo capsule once daily up to 48 weeks, however, participants received GSK2248761 100 once daily and matching GSK2248761 Placebo capsule once daily up to 8 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
GSK2248761 200 mg Once Daily Eligible participants were planned to receive oral GSK2248761 200 mg (2x100 mg) capsule once daily up to 48 weeks, however, participants received GSK2248761 200 mg oral capsule once daily up to 8 weeks due early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
EFV 600 mg Once Daily Eligible participants were planned to receive oral EFV 600 mg tablet once daily up to 48 weeks, however participants received EFV 600 mg tablet once daily up to 16 weeks due to early termination. All participants received ART of TDF/FTC 300 mg/200 mg or ABC/3TC 600 mg/300 mg along with the study drug.
Total Total of all reporting groups

Baseline Measures
   GSK2248761 100 mg Once Daily   GSK2248761 200 mg Once Daily   EFV 600 mg Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   8   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.8  (8.01)   35.9  (6.47)   35.9  (7.97)   36.9  (7.35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      1  14.3%      0   0.0%      1   4.3% 
Male      8 100.0%      6  85.7%      8 100.0%      22  95.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  12.5%      0   0.0%      0   0.0%      1   4.3% 
White      7  87.5%      7 100.0%      8 100.0%      22  95.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Plasma HIV-1 RNA Below 50 Copies/mL as a Function of Viral Load   [ Time Frame: Up to Week 16 ]

2.  Primary:   Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)   [ Time Frame: Up to 20 Weeks ]

3.  Secondary:   Change From Baseline (Day 1) in Plasma HIV-1 RNA Over Period   [ Time Frame: Baseline (Day 1) up to Week 16 ]

4.  Secondary:   Number of Participants With HIV Associated Conditions   [ Time Frame: Up to 20 Weeks ]

5.  Secondary:   Number of Participants With HIV Disease Progression   [ Time Frame: Up to 20 Weeks ]

6.  Secondary:   Number of Participants Discontinuing the Study Drugs Due to AEs   [ Time Frame: Up to 20 weeks ]

7.  Secondary:   Number of Participants With Changes in Electrocardiogram (ECG) From Baseline (Day 1) Over 16 Weeks   [ Time Frame: Baseline (Day 1) to 16 weeks ]

8.  Secondary:   Minimum and Maximum Plasma GSK2248761 Concentration at Week 2   [ Time Frame: At Week 2 ]


  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
No text entered.


  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: ViiV Healthcare
phone: 866-435-7343


Publications:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01231555     History of Changes
Other Study ID Numbers: 113404
First Submitted: October 14, 2010
First Posted: November 1, 2010
Results First Submitted: August 28, 2017
Results First Posted: November 16, 2017
Last Update Posted: November 16, 2017