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Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00920426
First Posted: June 15, 2009
Last Update Posted: December 6, 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.
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
Results First Submitted: July 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1265744 30mg
Drug: Placebo
Drug: GSK1265744 5mg

  Participant Flow
  Hide 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 study was conducted at 4 centers in the United States from 09 June 2009 to 13 August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 9 participants were randomized in the current study to receive 5 milligrams (mg) of GSK1265744 or Placebo. A total of 8 participants were previously randomized in study ITZ111451 part C HIV cohort, NCT00659191 to receive 30 mg of GSK1265744 once daily.

Reporting Groups
  Description
GSK1265744 30 mg GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
GSK1265744 5 mg Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Placebo Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Optimized Therapy Participants were given investigator chosen optimized therapy for 14 days after being dosed with the randomized regimen (either 5 mg GSK1265744 or Placebo) for 10 days. Participants were unblinded on Day 11 so that the participants receiving Placebo could decline optimized therapy.

Participant Flow for 3 periods

Period 1:   ITZ111451
    GSK1265744 30 mg   GSK1265744 5 mg   Placebo   Optimized Therapy
STARTED   8   0   0   0 
COMPLETED   7   0   0   0 
NOT COMPLETED   1   0   0   0 
Adverse Event                1                0                0                0 

Period 2:   ITZ112929: Randomized Regimen
    GSK1265744 30 mg   GSK1265744 5 mg   Placebo   Optimized Therapy
STARTED   0   7   2   0 
COMPLETED   0   7   2   0 
NOT COMPLETED   0   0   0   0 

Period 3:   ITZ112929: Optimized Therapy (OT)
    GSK1265744 30 mg   GSK1265744 5 mg   Placebo   Optimized Therapy
STARTED   0   0   0   8 [1] 
COMPLETED   0   0   0   8 
NOT COMPLETED   0   0   0   0 
[1] Out of 9 participants receiving randomized regimen, 8 participants continued to receive OT.



  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
GSK1265744 30 mg GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.
GSK1265744 5 mg Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Placebo Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Total Total of all reporting groups

Baseline Measures
   GSK1265744 30 mg   GSK1265744 5 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   2   17 
Age, Customized 
[Units: Participants]
Count of Participants
       
27 to 51 Years   8   7   2   17 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      2  28.6%      0   0.0%      2  11.8% 
Male      8 100.0%      5  71.4%      2 100.0%      15  88.2% 
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      0   0.0%      2  28.6%      0   0.0%      2  11.8% 
White      8 100.0%      5  71.4%      2 100.0%      15  88.2% 
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:   Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) to Day 11   [ Time Frame: Baseline (Day 1) and Day 11 ]

2.  Primary:   GSK1265744 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments(AUC[0-24])   [ Time Frame: Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) ]

3.  Primary:   GSK1265744 PK Parameters Following Dose Administration on Day 1: Concentration at 24 Hours Post Dose (C24)   [ Time Frame: Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) ]

4.  Primary:   GSK1265744 PK Parameters Following Dose Administration on Day 10: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau])   [ Time Frame: Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) ]

5.  Primary:   GSK1265744 PK Parameters Following Dose Administration on Day 10: Predose Concentration (C0), Concentration at End of Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin)   [ Time Frame: Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) ]

6.  Primary:   GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Maximum Observed Concentration (Cmax)   [ Time Frame: Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10 ]

7.  Primary:   GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Time to Cmax (Tmax)   [ Time Frame: Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10 ]

8.  Primary:   GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Terminal Half-life (t1/2) and Absorption Lag Time (Tlag)   [ Time Frame: Day 1 and Day 10 ]

9.  Primary:   GSK1265744 PK Parameters Following Last Repeat Administration on Day 10: Apparent Clearance Following Oral Dosing (CL/F)   [ Time Frame: Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) ]

10.  Primary:   Number of Participants With Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Day 1 to Day 11 ]

11.  Primary:   Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC- Absolute Neutrophil Count), White Blood Cell Count   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

12.  Primary:   Change From Baseline in Hematology Parameters: Hemoglobin   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

13.  Primary:   Change From Baseline in Hematology Parameters: Mean Corpuscle Hemoglobin   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

14.  Primary:   Change From Baseline in Hematology Parameters: Mean Corpuscle Volume   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

15.  Primary:   Change From Baseline in Hematology Parameters: Platelet Count   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

16.  Primary:   Change From Baseline in Hematology Parameters: Red Blood Cell Count   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

17.  Primary:   Change From Baseline in Hematology Parameters: Reticulocytes   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

18.  Primary:   Change From Baseline in Clinical Chemistry Data: Albumin, Total Protein   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

19.  Primary:   Change From Baseline in Clinical Chemistry Data: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Lipase   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

20.  Primary:   Change From Baseline in Direct Bilirubin, Total Bilirubin, Calcium, Cholesterol, Creatinine, Glucose, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, Triglycerides, Urea/Blood Urea Nitrogen   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

21.  Primary:   Change From Baseline in Clinical Chemistry Data: Chloride, Carbon Dioxide Content/Bicarbonate, Magnesium, Sodium, Potassium   [ Time Frame: Baseline (Day 1) and Day 3, 7, 10 ]

22.  Primary:   Number of Participants With Urinalysis Data   [ Time Frame: Day 1 to Day 10 ]

23.  Primary:   Change From Baseline in Vital Sign: Systolic and Diastolic Blood Pressure   [ Time Frame: Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10 ]

24.  Primary:   Change From Baseline in Vital Sign: Heart Rate   [ Time Frame: Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10 ]

25.  Primary:   Change From Baseline in Electrocardiogram (ECG) Parameters   [ Time Frame: Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10 ]

26.  Secondary:   Change From Baseline in Plasma HIV-1 RNA   [ Time Frame: Baseline (Day 1 pre-dose) and Day 1 (post dose), 2, 3, 4, 7, 8, 9, 10 ]

27.  Secondary:   Change From Baseline in Plasma HIV-1 RNA to Nadir Over 11 Days   [ Time Frame: Baseline (Day 1) and Day 11 ]

28.  Secondary:   Plasma HIV-1 RNA Rate of Decline (Slope) Over 11 Days   [ Time Frame: Up to Day 10 ]

29.  Secondary:   Number of Participants With HIV-1 RNA<400 Copies/mL   [ Time Frame: Up to Day 11 ]

30.  Secondary:   Number of Participants With HIV-1 RNA<50 Copies/mL   [ Time Frame: Up to Day 11 ]

31.  Secondary:   Change From Baseline in CD4+ Cell Count to Day 11   [ Time Frame: Baseline (Day 1) and Day 11 ]

32.  Secondary:   Pre-morning Dose Concentrations (C0) on Day 2 Through 10 to Assess the Achievement of Steady State of GSK1265744 Following Repeat Administration   [ Time Frame: Day 1 24 hours (Day 2), Pre-dose on Days 3, 4, 7, 8, 9 and 10 ]

33.  Secondary:   Accumulation Ratios for AUC, Cmax, and Ctau   [ Time Frame: Days 1 and 10 ]

34.  Secondary:   Day 1 AUC(0-24) at Different Doses for the Assessment of Dose Proportionality Using Power Model   [ Time Frame: Day 1 ]

35.  Secondary:   Day 1 Cmax and C24 at Different Doses for the Assessment of Dose Proportionality Using Power Model   [ Time Frame: Day 1 ]

36.  Secondary:   Day 10 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality Using Power Model   [ Time Frame: Day 10 ]

37.  Secondary:   Day 10 Cmax, C0 and Ctau at Different Doses for the Assessment of Dose Proportionality Using Power Model   [ Time Frame: Day 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: NCT00920426     History of Changes
Other Study ID Numbers: 112929
First Submitted: June 12, 2009
First Posted: June 15, 2009
Results First Submitted: July 18, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017