A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00950859
First received: July 23, 2009
Last updated: January 9, 2014
Last verified: November 2013
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572 (Cohort I)
Drug: GSK1349572 (Cohort II)

  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
Participants recruited initially to Cohort I and subsequently to Cohort II. Recruitment to Cohort I was closed 9 months before recruitment to Cohort II was opened. Recruitment was not randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort I (DTG 50 mg OD) Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Cohort II (DTG 50 mg BID) Participants received DTG 50 mg twice a day (BID).

Participant Flow:   Overall Study
    Cohort I (DTG 50 mg OD)     Cohort II (DTG 50 mg BID)  
STARTED     27     24  
Ongoing     13     19  
COMPLETED     0     0  
NOT COMPLETED     27     24  
Adverse Event                 2                 2  
Insufficient Viral Load Response                 12                 2  
Protocol Violation                 0                 1  
Ongoing                 13                 19  



  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
Cohort I (DTG 50 mg OD) Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Cohort II (DTG 50 mg BID) Participants received DTG 50 mg twice a day (BID).
Total Total of all reporting groups

Baseline Measures
    Cohort I (DTG 50 mg OD)     Cohort II (DTG 50 mg BID)     Total  
Number of Participants  
[units: participants]
  27     24     51  
Age, Customized  
[units: Years]
Median ( Full Range )
     
Years     48  
  ( 19 to 61 )  
  47  
  ( 33 to 68 )  
  47  
  ( 19 to 68 )  
Gender  
[units: Participants]
     
Female     2     6     8  
Male     25     18     43  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     3     5     8  
White-Arabic/North African Heritage     1     1     2  
White-White/Caucasian/European Heritage     23     18     41  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11   [ Time Frame: Baseline (Day 1) and Day 11 ]

2.  Secondary:   Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, and 96   [ Time Frame: Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, and 96 ]

3.  Secondary:   Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.   [ Time Frame: Baseline; Weeks 4, 12, 24, 48, 72, and 96 ]

4.  Secondary:   Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, and 96   [ Time Frame: Baseline; Day 11; Weeks 4, 12, 24, 48, 72, and 96 ]

5.  Secondary:   Cmax, Cmin, and Ctau of DTG   [ Time Frame: Day 10 ]

6.  Secondary:   C0 Assessment of DTG   [ Time Frame: Day 10; Weeks 4 and 24 ]

7.  Secondary:   Tmax of DTG   [ Time Frame: Day 10 ]

8.  Secondary:   AUC0-24 Assessment of DTG   [ Time Frame: Day 10 ]

9.  Secondary:   Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences   [ Time Frame: From the day of the first dose of study drug to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II ]

10.  Secondary:   Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death   [ Time Frame: From the day of the first dose of study drug to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II ]

11.  Secondary:   Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, and 96   [ Time Frame: Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 ]

12.  Secondary:   Number of Participants With the Indicated Genotypic Resistance at Baseline   [ Time Frame: Baseline ]

13.  Secondary:   Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group   [ Time Frame: Baseline (Day 1) ]

14.  Secondary:   Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance   [ Time Frame: From Baseline (Day 1) to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]

15.  Secondary:   Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance   [ Time Frame: From Baseline (Day 1) to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]

16.  Secondary:   Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities   [ Time Frame: From the day of the first dose of study drug to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]

17.  Secondary:   Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities   [ Time Frame: From Baseline (Day 1) to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]


  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: ViiV Healthcare
phone: 866-435-7343


Publications:
Eron JJ, Clotet B, Durant J, et al. Safety and efficacy of dolutegravir (DTG) in HIV-1 treatment-experienced subjects with raltegravir-resistant virus: 24-week results of the VIKING study. J Infect Dis. 2013;207(5):740-8.


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00950859     History of Changes
Other Study ID Numbers: 112961
Study First Received: July 23, 2009
Results First Received: August 15, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration