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Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection (SONNET)

This study has been terminated.
(The study was stopped due to safety concerns)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01199731
First Posted: September 13, 2010
Last Update Posted: November 17, 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 17, 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: Etravirine

  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
A total of 17 investigational sites enrolled participants in this multicenter study: 1 center in Romania and 16 in the United States. The study was initiated on 04 October 2010 and was terminated on 01 April 2011 with last participant visit on 19 July 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment in this study was terminated prematurely due to a safety finding (convulsions) in 5/20 participants who received GSK2248761. At time of enrollment termination, 30/150 planned participants were enrolled.

Reporting Groups
  Description
GSK2248761 100 Milligram (mg) Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, Darunavir (DRV) 1 x 600 mg tablet twice daily with food orally, Ritonavir (RTV) 1 x 100 mg tablet twice daily orally and Raltegravir(RAL) 1 x 400 mg tablet twice daily orally up to 48 weeks.
GSK2248761 200 mg Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
Etravirine (ETV) Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.

Participant Flow:   Overall Study
    GSK2248761 100 Milligram (mg)   GSK2248761 200 mg   Etravirine (ETV)
STARTED   9   11   10 
COMPLETED   0   0   0 
NOT COMPLETED   9   11   10 
Adverse Event                0                1                0 
Study closed/terminated                7                9                7 
Lost to Follow-up                0                0                2 
Physician Decision                0                1                1 
Withdrawal by Subject                2                0                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 Participants received GSK2248761 1 x 100 mg capsule once daily orally, 1 x Placebo to match GSK2248761 capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
GSK2248761 200 mg Participants received GSK2248761 2 x 100 mg capsule once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
ETV 200 mg Participants received ETV 2 x 100 mg tablet once daily orally, DRV 1 x 600 mg tablet twice daily with food orally, RTV 1 x 100 mg tablet twice daily orally and RAL 1 x 400 mg tablet twice daily orally up to 48 weeks.
Total Total of all reporting groups

Baseline Measures
   GSK2248761 100 mg   GSK2248761 200 mg   ETV 200 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   11   10   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (9.11)   42.4  (11.60)   43.2  (8.75)   43.6  (9.74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2  22.2%      2  18.2%      5  50.0%      9  30.0% 
Male      7  77.8%      9  81.8%      5  50.0%      21  70.0% 
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      1  11.1%      0   0.0%      0   0.0%      1   3.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  33.3%      5  45.5%      6  60.0%      14  46.7% 
White      5  55.6%      5  45.5%      4  40.0%      14  46.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   9.1%      0   0.0%      1   3.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies Per Milliliter (/mL) at Week 16   [ Time Frame: At Week 16 ]

2.  Secondary:   Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011) ]

3.  Secondary:   Number of Participants With Abnormal Clinical Chemistry Laboratory Data With Grade 3 or 4 Treatment-Emergent (TE) Toxicities   [ Time Frame: Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011) ]

4.  Secondary:   Number of Participants With Abnormal Hematology Laboratory Data With Grade 3 or 4 TE Toxicities   [ Time Frame: Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011) ]

5.  Secondary:   Change From Baseline in Plasma HIV-1 RNA Prior to Switch of GSK2248761   [ Time Frame: Baseline (Day 1) and Week 2, 4, 8, 12 and 16 ]

6.  Secondary:   Change From Baseline in Plasma HIV-1 RNA After Switch of GSK2248761   [ Time Frame: Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and follow-up Week 4, 8, 12 ]

7.  Secondary:   Number of Participants Who Experienced Disease Progression (HIV-associated Conditions, AIDS and Death)   [ Time Frame: Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011) ]

8.  Secondary:   Absolute Values of CD4+ Cell Counts After Switch of GSK2248761   [ Time Frame: Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and Follow-up Week 4, 8, 12 ]

9.  Secondary:   Change From Baseline in CD4+ Cell Counts Prior to Switch of GSK2248761   [ Time Frame: Baseline (Day 1) and Week 2, 4, 8, 12 and 16 ]

10.  Secondary:   Change From Baseline in CD4+ Cell Counts After Switch of GSK2248761   [ Time Frame: Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and Follow-up Week 4, 8, 12 ]

11.  Secondary:   Number of Participants Who Discontinued Treatment Due to AEs   [ Time Frame: Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011) ]

12.  Secondary:   Number of Participants With Electrocardiograph (ECG) With Values of Potential Critical Concern (PCI)   [ Time Frame: Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011) ]


  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
Enrollment in this study was terminated prematurely on 01 April 2011 due to a safety finding (convulsion) in 5/20 participants receiving GSK2248761.


  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



Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01199731     History of Changes
Other Study ID Numbers: 113399
First Submitted: September 9, 2010
First Posted: September 13, 2010
Results First Submitted: August 17, 2017
Results First Posted: October 12, 2017
Last Update Posted: November 17, 2017