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

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ClinicalTrials.gov Identifier: NCT00920426
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

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
Enrollment 9
Recruitment Details This study was conducted at 4 centers in the United States from 09 June 2009 to 13 August 2009.
Pre-assignment Details 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.
Arm/Group Title GSK1265744 30 mg GSK1265744 5 mg Placebo Optimized Therapy
Hide Arm/Group Description 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. Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. 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.
Period Title: ITZ111451
Started 8 0 0 0
Completed 7 0 0 0
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Period Title: ITZ112929: Randomized Regimen
Started 0 7 2 0
Completed 0 7 2 0
Not Completed 0 0 0 0
Period Title: ITZ112929: Optimized Therapy (OT)
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.
Arm/Group Title GSK1265744 30 mg GSK1265744 5 mg Placebo Total
Hide Arm/Group Description 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. Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. Total of all reporting groups
Overall Number of Baseline Participants 8 7 2 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
27 to 51 Years Number Analyzed 8 participants 7 participants 2 participants 17 participants
8
 100.0%
7
 100.0%
2
 100.0%
17
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 2 participants 17 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 2 participants 17 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%
1.Primary Outcome
Title Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) to Day 11
Hide Description Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a lower limit of detection (LLOD) of 50 copies/milliliter (mL) (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population comprised of all participants who met study criteria and randomized into study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post-baseline HIV-1 RNA measurement. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.169  (0.2405) -0.092  (0.1499)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1265744 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.090
Confidence Interval (2-Sided) 95%
-2.547 to -1.632
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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])
Hide Description Blood samples for PK analysis of AUC(0-24) of GSK1265744 was collected on 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). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population included participants with evaluable PK profile of GSK1265744 on Day 10. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter (hr*µg/mL)
7.53
(23%)
3.Primary Outcome
Title GSK1265744 PK Parameters Following Dose Administration on Day 1: Concentration at 24 Hours Post Dose (C24)
Hide Description Blood samples for PK analysis of C24 of GSK1265744 was collected on 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). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (µg/mL)
0.23
(28%)
4.Primary Outcome
Title GSK1265744 PK Parameters Following Dose Administration on Day 10: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau])
Hide Description Blood samples for PK analysis of C24 of GSK1265744 was collected on 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). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*µg/mL
17.74
(31%)
5.Primary Outcome
Title 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)
Hide Description Blood samples for PK analysis of C0, Ctau and Cmin of GSK1265744 was collected on 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). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
C0
0.54
(36%)
Ctau
0.57
(33%)
Cmin
0.53
(35%)
6.Primary Outcome
Title GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Maximum Observed Concentration (Cmax)
Hide Description Blood samples for PK analysis of Cmax of GSK1265744 was collected at 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. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Day 1
0.52
(20%)
Day 10
1.02
(25%)
7.Primary Outcome
Title GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Time to Cmax (Tmax)
Hide Description Blood samples for PK analysis of tmax of GSK1265744 was collected at 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. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: Hour
Day 1
2.00
(1.00 to 4.08)
Day 10
2.00
(1.50 to 4.08)
8.Primary Outcome
Title GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Terminal Half-life (t1/2) and Absorption Lag Time (Tlag)
Hide Description PK sampling was planned to be collected up to 24 hours only on Day 1 and Day 10. The data for this outcome measure was however not collected.
Time Frame Day 1 and Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population. Data for this outcome measure was not collected. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title GSK1265744 PK Parameters Following Last Repeat Administration on Day 10: Apparent Clearance Following Oral Dosing (CL/F)
Hide Description Blood samples for PK analysis of CL/F of GSK1265744 was collected on 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). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter per hour (L/hr)
0.28
(31%)
10.Primary Outcome
Title Number of Participants With Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or is associated with liver injury and impaired liver function.
Time Frame Day 1 to Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who were randomized into the study with documented evidence of having received at least 1 dose of randomized treatment. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo Optimized Therapy
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
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.
Overall Number of Participants Analyzed 7 2 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
0
   0.0%
2
 100.0%
3
  37.5%
Any SAEs
0
   0.0%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC- Absolute Neutrophil Count), White Blood Cell Count
Hide Description Blood samples for assessment of hematology parameters of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC- absolute neutrophil count) and white blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Thousand cells per microliter
Basophils, Day 3 0.017  (0.0287) 0.005  (0.0071)
Basophils, Day 7 0.007  (0.0125) 0.015  (0.0071)
Basophils, Day 10 0.009  (0.0146) 0.020  (0.0000)
Eosinophils, Day 3 -0.024  (0.0408) 0.250  (0.4101)
Eosinophils, Day 7 -0.039  (0.0498) 0.325  (0.5869)
Eosinophils, Day 10 -0.009  (0.0628) -0.055  (0.1485)
Lymphocytes, Day 3 0.197  (0.2870) -0.500  (0.3111)
Lymphocytes, Day 7 0.190  (0.2514) -0.525  (0.1485)
Lymphocytes, Day 10 0.229  (0.2738) -0.720  (0.5515)
Monocytes, Day 3 -0.030  (0.0876) 0.170  (0.2121)
Monocytes, Day 7 -0.039  (0.1126) 0.035  (0.1626)
Monocytes, Day 10 0.056  (0.0774) -0.005  (0.2192)
Total Neutrophils, Day 3 0.181  (0.6097) -0.080  (0.1273)
Total Neutrophils, Day 7 -0.003  (0.6304) -0.155  (0.2192)
Total Neutrophils, Day 10 0.831  (1.6043) 0.405  (1.1384)
White blood cell count, Day 3 0.34  (0.282) -0.15  (1.061)
White blood cell count, Day 7 0.11  (0.782) -0.30  (1.131)
White blood cell count, Day 10 1.11  (1.508) -0.35  (1.626)
12.Primary Outcome
Title Change From Baseline in Hematology Parameters: Hemoglobin
Hide Description Blood samples for assessment of hematology parameter of hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Grams per deciliter
Day 3 0.13  (0.637) -0.30  (0.424)
Day 7 0.06  (0.519) 0.00  (0.424)
Day 10 -0.17  (0.446) -0.15  (0.354)
13.Primary Outcome
Title Change From Baseline in Hematology Parameters: Mean Corpuscle Hemoglobin
Hide Description Blood samples for assessment of hematology parameter of mean corpuscle hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Picogram
Day 3 -0.03  (0.198) 0.25  (0.495)
Day 7 0.37  (0.411) 0.30  (0.141)
Day 10 0.00  (0.306) 0.40  (0.424)
14.Primary Outcome
Title Change From Baseline in Hematology Parameters: Mean Corpuscle Volume
Hide Description Blood samples for assessment of hematology parameter of mean corpuscle volume was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Femtoliter
Day 3 1.0  (1.15) 0.5  (0.71)
Day 7 1.0  (1.63) -0.5  (0.71)
Day 10 1.7  (1.11) 0.0  (1.41)
15.Primary Outcome
Title Change From Baseline in Hematology Parameters: Platelet Count
Hide Description Blood samples for assessment of hematology parameter of platelet count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
Day 3 10428.6  (8847.92) 5000.0  (21213.20)
Day 7 15142.9  (29299.76) 2500.0  (2121.32)
Day 10 8000.0  (23860.71) 9500.0  (37476.66)
16.Primary Outcome
Title Change From Baseline in Hematology Parameters: Red Blood Cell Count
Hide Description Blood samples for assessment of hematology parameter of red blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Million cells per microliter
Day 3 0.03  (0.221) -0.15  (0.071)
Day 7 -0.06  (0.151) -0.05  (0.071)
Day 10 -0.09  (0.135) -0.10  (0.141)
17.Primary Outcome
Title Change From Baseline in Hematology Parameters: Reticulocytes
Hide Description Blood samples for assessment of hematology parameter of reticulocytes was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Giga cells per liter
Day 3 5.51  (9.971) 9.45  (1.768)
Day 7 13.79  (27.361) -6.50  (0.849)
Day 10 13.79  (16.419) 21.30  (35.497)
18.Primary Outcome
Title Change From Baseline in Clinical Chemistry Data: Albumin, Total Protein
Hide Description Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Grams per deciliter
Albumin, Day 3 Number Analyzed 7 participants 2 participants
0.16  (0.162) 0.00  (0.000)
Albumin, Day 7 Number Analyzed 6 participants 2 participants
0.08  (0.117) 0.05  (0.071)
Albumin, Day 10 Number Analyzed 7 participants 2 participants
0.06  (0.098) 0.15  (0.071)
Total protein, Day 3 Number Analyzed 7 participants 2 participants
0.24  (0.447) 0.05  (0.212)
Total protein, Day 7 Number Analyzed 6 participants 2 participants
0.03  (0.294) 0.10  (0.424)
Total protein, Day 10 Number Analyzed 7 participants 2 participants
-0.10  (0.342) 0.10  (0.000)
19.Primary Outcome
Title Change From Baseline in Clinical Chemistry Data: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Lipase
Hide Description Blood samples for assessment of clinical chemistry parameters of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and lipase was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Units per liter
Alkaline phosphatase, Day 3 Number Analyzed 7 participants 2 participants
1.6  (3.10) -3.5  (4.95)
Alkaline phosphatase, Day 7 Number Analyzed 6 participants 2 participants
0.5  (3.89) -5.0  (0.00)
Alkaline phosphatase, Day 10 Number Analyzed 7 participants 2 participants
-2.4  (6.55) -4.0  (2.83)
Alanine amino transferase, Day 3 Number Analyzed 7 participants 2 participants
2.9  (6.41) -4.0  (2.83)
Alanine amino transferase, Day 7 Number Analyzed 6 participants 2 participants
-0.2  (4.02) -1.5  (9.19)
Alanine amino transferase, Day 10 Number Analyzed 7 participants 2 participants
2.0  (4.12) -2.5  (7.78)
Aspartate amino transferase, Day 3 Number Analyzed 7 participants 2 participants
-1.0  (4.28) -2.0  (8.49)
Aspartate amino transferase, Day 7 Number Analyzed 6 participants 2 participants
-1.0  (3.52) -3.5  (7.78)
Aspartate amino transferase, Day 10 Number Analyzed 7 participants 2 participants
0.4  (5.32) -2.0  (5.66)
Creatine kinase, Day 3 Number Analyzed 7 participants 2 participants
-0.1  (11.42) -29.5  (10.61)
Creatine kinase, Day 7 Number Analyzed 6 participants 2 participants
27.7  (77.11) -48.0  (42.43)
Creatine kinase, Day 10 Number Analyzed 7 participants 2 participants
20.6  (42.97) -40.5  (43.13)
Lipase, Day 3 Number Analyzed 7 participants 2 participants
0.9  (8.91) 4.0  (2.83)
Lipase, Day 7 Number Analyzed 7 participants 2 participants
-0.9  (17.22) -1.0  (8.49)
Lipase, Day 10 Number Analyzed 7 participants 2 participants
0.3  (14.42) -2.0  (2.83)
20.Primary Outcome
Title 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
Hide Description Blood samples for assessment of clinical chemistry parameters of direct bilirubin, total bilirubin, calcium, cholesterol, creatinine, glucose, HDL cholesterol direct, LDL cholesterol calculation, triglycerides,Urea/BUN was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter
Direct bilirubin, Day 3 Number Analyzed 7 participants 2 participants
-0.04  (0.113) -0.05  (0.071)
Direct bilirubin, Day 7 Number Analyzed 6 participants 2 participants
-0.10  (0.126) -0.05  (0.071)
Direct bilirubin, Day 10 Number Analyzed 7 participants 2 participants
-0.06  (0.053) 0.00  (0.000)
Total bilirubin, Day 3 Number Analyzed 7 participants 2 participants
-0.06  (0.207) -0.25  (0.354)
Total bilirubin, Day 7 Number Analyzed 6 participants 2 participants
-0.03  (0.186) -0.40  (0.566)
Total bilirubin, Day 10 Number Analyzed 7 participants 2 participants
0.00  (0.216) -0.10  (0.141)
Calcium, Day 3 Number Analyzed 7 participants 2 participants
0.13  (0.198) 0.00  (0.141)
Calcium, Day 7 Number Analyzed 6 participants 2 participants
0.17  (0.207) 0.05  (0.495)
Calcium, Day 10 Number Analyzed 7 participants 2 participants
-0.09  (0.254) 0.20  (0.000)
Cholesterol, Day 3 Number Analyzed 7 participants 2 participants
5.7  (8.90) -7.5  (9.19)
Cholesterol, Day 7 Number Analyzed 6 participants 2 participants
16.2  (32.60) 0.0  (1.41)
Cholesterol, Day 10 Number Analyzed 7 participants 2 participants
4.0  (13.17) 1.0  (2.83)
Creatinine, Day 3 Number Analyzed 7 participants 2 participants
0.03  (0.049) 0.05  (0.071)
Creatinine, Day 7 Number Analyzed 6 participants 2 participants
0.05  (0.105) 0.05  (0.071)
Creatinine, Day 10 Number Analyzed 7 participants 2 participants
0.03  (0.076) 0.05  (0.071)
Glucose, Day 3 Number Analyzed 7 participants 2 participants
16.1  (28.35) 2.0  (1.41)
Glucose, Day 7 Number Analyzed 6 participants 2 participants
-16.5  (45.62) 4.5  (3.54)
Glucose, Day 10 Number Analyzed 7 participants 2 participants
0.1  (5.81) -4.0  (0.00)
HDL cholesterol, direct, Day 3 Number Analyzed 7 participants 2 participants
-0.6  (2.44) -1.5  (2.12)
HDL cholesterol, direct, Day 7 Number Analyzed 6 participants 2 participants
-0.2  (9.62) 0.5  (0.71)
HDL cholesterol, direct, Day 10 Number Analyzed 7 participants 2 participants
1.9  (4.56) -2.0  (1.41)
LDL cholesterol calculation, Day 3 Number Analyzed 7 participants 2 participants
6.7  (9.21) -7.0  (12.73)
LDL cholesterol calculation, Day 7 Number Analyzed 5 participants 2 participants
-0.2  (9.93) 3.5  (6.36)
LDL cholesterol calculation, Day 10 Number Analyzed 7 participants 2 participants
1.6  (10.42) -2.5  (16.26)
Triglycerides, Day 3 Number Analyzed 7 participants 2 participants
-1.9  (49.69) 5.0  (4.24)
Triglycerides, Day 7 Number Analyzed 6 participants 2 participants
258.3  (636.46) -20.5  (21.92)
Triglycerides, Day 10 Number Analyzed 7 participants 2 participants
3.6  (39.59) 28.5  (72.83)
Urea/BUN, Day 3 Number Analyzed 7 participants 2 participants
1.4  (2.15) -1.0  (5.66)
Urea/BUN, Day 7 Number Analyzed 6 participants 2 participants
1.3  (3.27) -2.5  (4.95)
Urea/BUN, Day 10 Number Analyzed 7 participants 2 participants
0.7  (2.81) -2.0  (0.00)
21.Primary Outcome
Title Change From Baseline in Clinical Chemistry Data: Chloride, Carbon Dioxide Content/Bicarbonate, Magnesium, Sodium, Potassium
Hide Description Blood samples for assessment of clinical chemistry parameters of chloride, carbon dioxide content/bicarbonate, magnesium, sodium and potassium was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 3, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Milliequivalents per liter
Chloride, Day 3 Number Analyzed 7 participants 2 participants
0.0  (0.82) 2.0  (0.00)
Chloride, Day 7 Number Analyzed 6 participants 2 participants
-0.2  (2.79) 2.0  (0.00)
Chloride, Day 10 Number Analyzed 7 participants 2 participants
-0.7  (2.69) 2.0  (4.24)
Carbon dioxide content/Bicarbonate, Day 3 Number Analyzed 7 participants 2 participants
-0.9  (2.41) -1.0  (0.00)
Carbon dioxide content/Bicarbonate, Day 7 Number Analyzed 6 participants 2 participants
-1.3  (1.63) -2.0  (2.83)
Carbon dioxide content/Bicarbonate, Day 10 Number Analyzed 7 participants 2 participants
0.6  (2.76) -2.0  (2.83)
Potassium, Day 3 Number Analyzed 7 participants 2 participants
0.20  (0.200) 0.30  (0.141)
Potassium, Day 7 Number Analyzed 6 participants 2 participants
0.00  (0.245) 0.20  (0.283)
Potassium, Day 10 Number Analyzed 7 participants 2 participants
0.07  (0.368) 0.05  (0.212)
Magnesium, Day 3 Number Analyzed 7 participants 2 participants
-0.04  (0.098) 0.10  (0.000)
Magnesium, Day 7 Number Analyzed 6 participants 2 participants
-0.00  (0.089) 0.10  (0.141)
Magnesium, Day 10 Number Analyzed 7 participants 2 participants
-0.04  (0.098) 0.00  (0.141)
Sodium, Day 3 Number Analyzed 7 participants 2 participants
-0.4  (1.62) 0.5  (0.71)
Sodium, Day 7 Number Analyzed 6 participants 2 participants
0.3  (2.50) 0.5  (0.71)
Sodium, Day 10 Number Analyzed 7 participants 2 participants
-0.4  (1.62) 0.5  (2.12)
22.Primary Outcome
Title Number of Participants With Urinalysis Data
Hide Description Samples for urinalysis assessment was collected on Day 1, Day 3 and Day 10. Urinalysis parameters included urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine pH, urine protein, urine specific gravity and urine leukocyte esterase test for detecting white blood cell.
Time Frame Day 1 to Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1, Urine Bilirubin, Negative
7
 100.0%
2
 100.0%
Day 1, Urine Occult Blood, Negative
7
 100.0%
2
 100.0%
Day 1, Urine Glucose, Negative
7
 100.0%
2
 100.0%
Day 1, Urine Ketones, Negative
7
 100.0%
2
 100.0%
Day 1, Urine Nitrite, Negative
6
  85.7%
2
 100.0%
Day 1, Urine Nitrite, Positive
1
  14.3%
0
   0.0%
Day 1, Urine pH, 5.5
2
  28.6%
1
  50.0%
Day 1, Urine pH, 6
4
  57.1%
1
  50.0%
Day 1, Urine pH, 6.5
1
  14.3%
0
   0.0%
Day 1, Urine Protein, Negative
7
 100.0%
2
 100.0%
Day 1, Urine Specific Gravity, 1.006
1
  14.3%
0
   0.0%
Day 1, Urine Specific Gravity, 1.014
0
   0.0%
1
  50.0%
Day 1, Urine Specific Gravity, 1.015
0
   0.0%
1
  50.0%
Day 1, Urine Specific Gravity, 1.017
1
  14.3%
0
   0.0%
Day 1, Urine Specific Gravity, 1.019
2
  28.6%
0
   0.0%
Day 1, Urine Specific Gravity, 1.021
1
  14.3%
0
   0.0%
Day 1, Urine Specific Gravity, 1.025
1
  14.3%
0
   0.0%
Day 1, Urine Specific Gravity, 1.03
1
  14.3%
0
   0.0%
Day 1, ULET for white blood cell, Negative
7
 100.0%
2
 100.0%
Day 3, Urine Bilirubin, Negative
7
 100.0%
2
 100.0%
Day 3, Urine Occult Blood, Negative
6
  85.7%
2
 100.0%
Day 3, Urine Occult Blood, 1+
1
  14.3%
0
   0.0%
Day 3, Urine Glucose, 3+
1
  14.3%
0
   0.0%
Day 3, Urine Glucose, Negative
6
  85.7%
2
 100.0%
Day 3, Urine Ketones, Negative
7
 100.0%
2
 100.0%
Day 3, Urine Nitrite, Negative
6
  85.7%
2
 100.0%
Day 3, Urine Nitrite, Positive
1
  14.3%
0
   0.0%
Day 3, Urine pH, 5.5
4
  57.1%
1
  50.0%
Day 3, Urine pH, 6
2
  28.6%
1
  50.0%
Day 3, Urine pH, 6.5
1
  14.3%
0
   0.0%
Day 3, Urine Protein, Negative
6
  85.7%
2
 100.0%
Day 3, Urine Protein, Trace
1
  14.3%
0
   0.0%
Day 3, Urine Specific Gravity, 1.016
1
  14.3%
0
   0.0%
Day 3, Urine Specific Gravity, 1.017
1
  14.3%
1
  50.0%
Day 3, Urine Specific Gravity, 1.018
0
   0.0%
1
  50.0%
Day 3, Urine Specific Gravity, 1.021
2
  28.6%
0
   0.0%
Day 3, Urine Specific Gravity, 1.022
1
  14.3%
0
   0.0%
Day 3, Urine Specific Gravity, 1.027
1
  14.3%
0
   0.0%
Day 3, Urine Specific Gravity, 1.03
1
  14.3%
0
   0.0%
Day 3, ULET for white blood cell, 2+
1
  14.3%
0
   0.0%
Day 3, ULET for white blood cell, Negative
6
  85.7%
2
 100.0%
Day 10, Urine Bilirubin, Negative
7
 100.0%
2
 100.0%
Day 10, Urine Occult Blood, 2+
1
  14.3%
0
   0.0%
Day 10, Urine Occult Blood, Negative
6
  85.7%
2
 100.0%
Day 10, Urine Glucose, Negative
7
 100.0%
2
 100.0%
Day 10, Urine Ketones, Negative
7
 100.0%
2
 100.0%
Day 10, Urine Nitrite, Negative
6
  85.7%
2
 100.0%
Day 10, Urine Nitrite, Positive
1
  14.3%
0
   0.0%
Day 10, Urine pH, 5.5
0
   0.0%
1
  50.0%
Day 10, Urine pH, 6
4
  57.1%
1
  50.0%
Day 10, Urine pH, 6.5
3
  42.9%
0
   0.0%
Day 10, Urine Protein, Negative
5
  71.4%
2
 100.0%
Day 10, Urine Protein, Trace
2
  28.6%
0
   0.0%
Day 10, Urine Specific Gravity, 1.009
0
   0.0%
1
  50.0%
Day 10, Urine Specific Gravity, 1.016
0
   0.0%
1
  50.0%
Day 10, Urine Specific Gravity, 1.02
1
  14.3%
0
   0.0%
Day 10, Urine Specific Gravity, 1.021
1
  14.3%
0
   0.0%
Day 10, Urine Specific Gravity, 1.023
1
  14.3%
0
   0.0%
Day 10, Urine Specific Gravity, 1.025
2
  28.6%
0
   0.0%
Day 10, Urine Specific Gravity, 1.027
1
  14.3%
0
   0.0%
Day 10, Urine Specific Gravity, 1.03
1
  14.3%
0
   0.0%
Day 10, ULET for white blood cell, Negative
7
 100.0%
2
 100.0%
23.Primary Outcome
Title Change From Baseline in Vital Sign: Systolic and Diastolic Blood Pressure
Hide Description Systolic and diastolic blood pressure was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Systolic blood pressure, Day 1, 2 Hours 1.2  (8.59) 5.8  (0.35)
Systolic blood pressure, Day 4, Pre dose 1.8  (9.16) 5.8  (3.18)
Systolic blood pressure, Day 7, Pre dose -2.5  (11.22) -4.3  (8.84)
Systolic blood pressure, Day 10, Pre dose 0.6  (19.19) 19.8  (14.50)
Systolic blood pressure, Day 10, 2 Hours -0.2  (10.59) 13.3  (4.60)
Diastolic blood pressure, Day 1, 2 Hours -5.7  (5.76) -0.5  (2.12)
Diastolic blood pressure, Day 4, Pre dose -2.4  (8.91) -2.5  (10.61)
Diastolic blood pressure, Day 7, Pre dose -1.6  (9.28) -5.0  (15.56)
Diastolic blood pressure, Day 10, Pre dose -5.4  (13.85) 8.5  (14.85)
Diastolic blood pressure, Day 10, 2 Hours -2.4  (6.82) 6.5  (9.19)
24.Primary Outcome
Title Change From Baseline in Vital Sign: Heart Rate
Hide Description Heart rate was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1, 2 Hours -7.0  (2.10) -5.8  (4.60)
Day 4, Pre dose 5.3  (6.24) -5.8  (1.06)
Day 7, Pre dose 6.3  (5.71) -1.8  (1.77)
Day 10, Pre dose 0.0  (6.74) 5.8  (4.60)
Day 10, 2 Hours -7.6  (5.12) -10.8  (3.18)
25.Primary Outcome
Title Change From Baseline in Electrocardiogram (ECG) Parameters
Hide Description All ECGs were obtained after a minimum 10 minute rest in a semi-supine position. The 12-lead ECGs were obtained at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10 using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and Bazett’s correction (QTcB) and Fridericia correction (QTcF) intervals. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Milliseconds (msec)
PR, Day 1, 2 Hours 0.0  (1.83) 1.0  (2.83)
PR, Day 4, Pre dose 4.0  (5.42) 5.0  (11.31)
PR, Day 7, Pre dose -0.9  (4.67) 0.0  (12.73)
PR, Day 10, Pre dose -1.7  (3.04) 0.0  (9.90)
PR, Day 10, 2 Hours 4.3  (10.09) 4.0  (12.73)
QRS, Day 1, 2 Hours -0.7  (3.68) 1.5  (0.71)
QRS, Day 4, Pre dose 0.7  (2.36) -3.5  (12.02)
QRS, Day 7, Pre dose -0.1  (4.26) 3.5  (2.12)
QRS, Day 10, Pre dose 1.0  (5.07) 0.5  (3.54)
QRS, Day 10, 2 Hours -0.7  (8.99) 5.5  (4.95)
QT, Day 1, 2 Hours 18.1  (8.07) 27.0  (24.04)
QT, Day 4, Pre dose -10.7  (20.93) 5.0  (7.07)
QT, Day 7, Pre dose -13.6  (13.13) 11.0  (1.41)
QT, Day 10, Pre dose -3.3  (14.14) -11.0  (24.04)
QT, Day 10, 2 Hours 19.0  (22.15) 25.0  (24.04)
QTcB, Day 1, 2 Hours 0.2  (13.50) 6.0  (4.09)
QTcB, Day 4, Pre dose 2.0  (16.15) -17.9  (2.20)
QTcB, Day 7, Pre dose -0.0  (16.95) -9.0  (25.73)
QTcB, Day 10, Pre dose 1.4  (16.59) -15.6  (10.35)
QTcB, Day 10, 2 Hours -2.4  (12.35) -18.1  (0.42)
QTcF, Day 1, 2 Hours 6.4  (11.45) 13.3  (11.06)
QTcF, Day 4, Pre dose -2.4  (14.27) -10.0  (4.05)
QTcF, Day 7, Pre dose -4.7  (13.05) -2.0  (16.30)
QTcF, Day 10, Pre dose -0.2  (13.17) -13.9  (15.19)
QTcF, Day 10, 2 Hours 4.9  (13.62) -3.4  (7.99)
26.Secondary Outcome
Title Change From Baseline in Plasma HIV-1 RNA
Hide Description Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA were collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1 pre-dose) and Day 1 (post dose), 2, 3, 4, 7, 8, 9, 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Day 1 Number Analyzed 7 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
Day 2 Number Analyzed 7 participants 2 participants
-0.126  (0.2255) 0.058  (0.2303)
Day 3 Number Analyzed 7 participants 2 participants
-0.618  (0.1341) -0.299  (0.2737)
Day 4 Number Analyzed 7 participants 2 participants
-0.830  (0.2424) -0.146  (0.0580)
Day 7 Number Analyzed 7 participants 2 participants
-1.577  (0.5498) -0.168  (0.1264)
Day 8 Number Analyzed 7 participants 2 participants
-1.935  (0.4717) -0.146  (0.2779)
Day 9 Number Analyzed 7 participants 2 participants
-2.013  (0.4192) -0.007  (0.1960)
Day 10 Number Analyzed 7 participants 2 participants
-2.160  (0.2810) -0.158  (0.1930)
[1]
Only one participant was analyzed.
27.Secondary Outcome
Title Change From Baseline in Plasma HIV-1 RNA to Nadir Over 11 Days
Hide Description Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Nadir was the maximum change from Baseline in plasma HIV-1 RNA. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-2.199  (0.2491) -0.418  (0.1058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1265744 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.804
Confidence Interval (2-Sided) 95%
-2.173 to -1.436
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Plasma HIV-1 RNA Rate of Decline (Slope) Over 11 Days
Hide Description Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Estimated mean rate of decline (i.e., slope of day) with corresponding 90% confidence interval was provided for each treatment.
Time Frame Up to Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (90% Confidence Interval)
Unit of Measure: log10 copies per mL per day
-0.2313
(-0.2513 to -0.2113)
0.0013
(-0.0233 to 0.0259)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1265744 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
29.Secondary Outcome
Title Number of Participants With HIV-1 RNA<400 Copies/mL
Hide Description Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.
Time Frame Up to Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7
2
  28.6%
0
   0.0%
Day 8
4
  57.1%
0
   0.0%
Day 9
4
  57.1%
0
   0.0%
Day 10
5
  71.4%
0
   0.0%
Day 11
5
  71.4%
0
   0.0%
30.Secondary Outcome
Title Number of Participants With HIV-1 RNA<50 Copies/mL
Hide Description Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.
Time Frame Up to Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Measure Type: Count of Participants
Unit of Measure: Participants
Day 8
2
  28.6%
0
   0.0%
Day 9
3
  42.9%
0
   0.0%
Day 10
2
  28.6%
0
   0.0%
Day 11
2
  28.6%
0
   0.0%
31.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count to Day 11
Hide Description Whole venous blood samples was obtained from each participant for the analysis of lymphocyte subsets by flow cytometry on Day 1 and Day 11. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) and Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg Placebo
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7 2
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter
71.0  (56.62) -84.0  (145.66)
32.Secondary Outcome
Title Pre-morning Dose Concentrations (C0) on Day 2 Through 10 to Assess the Achievement of Steady State of GSK1265744 Following Repeat Administration
Hide Description Steady state is said to be reached, when the pre-dose concentration slope estimate is close to zero. The data for pre-dose concentration on Day 1 24 hours (Day 2) through Day 10 has been presented.
Time Frame Day 1 24 hours (Day 2), Pre-dose on Days 3, 4, 7, 8, 9 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: µg/mL
DAY 1, 24 hours (Day 2) 0.2363  (0.06884)
DAY 3, Pre-dose 0.3539  (0.12999)
DAY 4, Pre-dose 0.4128  (0.15566)
DAY 7, Pre-dose 0.5239  (0.11899)
DAY 8, Pre-dose 0.5744  (0.17622)
DAY 9, Pre-dose 0.5688  (0.16880)
DAY 10, Pre-dose 0.5654  (0.20609)
33.Secondary Outcome
Title Accumulation Ratios for AUC, Cmax, and Ctau
Hide Description The accumulation ratio was calculated as the ratio of AUC(0-τ), Cmax, and Ctau on Day 10 to AUC(0-24), Cmax, and C24 on Day 1 for each participant. The ratio of geometric least square means of each parameter on Day 10 to Day 1 was presented along with 90% confidence interval.
Time Frame Days 1 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK/ Pharmacodynamic (PD) Summary Population included participants who met the criteria for both ITT Population and PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.
Arm/Group Title GSK1265744 5 mg
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days.
Overall Number of Participants Analyzed 7
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: Ratio
Accumulation Ratio AUC
2.355
(2.086 to 2.658)
Accumulation Ratio Cmax
1.961
(1.684 to 2.283)
Accumulation Ratio Ctau
2.483
(2.141 to 2.880)
34.Secondary Outcome
Title Day 1 AUC(0-24) at Different Doses for the Assessment of Dose Proportionality Using Power Model
Hide Description Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (AUC[0-24]) using the power model. The mean slope and corresponding 90% confidence interval has been presented.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population.
Arm/Group Title Pooled GSK1265744
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
Overall Number of Participants Analyzed 15
Mean (90% Confidence Interval)
Unit of Measure: hr*µg/mL/mg
0.952
(0.802 to 1.101)
35.Secondary Outcome
Title Day 1 Cmax and C24 at Different Doses for the Assessment of Dose Proportionality Using Power Model
Hide Description Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (Cmax, and C24) using the power model. The mean slope and corresponding 90% confidence interval has been presented.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population.
Arm/Group Title Pooled GSK1265744
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
Overall Number of Participants Analyzed 15
Mean (90% Confidence Interval)
Unit of Measure: μg/mL/mg
Cmax
0.950
(0.812 to 1.088)
C24
0.949
(0.777 to 1.121)
36.Secondary Outcome
Title Day 10 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality Using Power Model
Hide Description Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (AUC[0-tau]) using the power model. The mean slope and corresponding 90% confidence interval has been presented.
Time Frame Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population.
Arm/Group Title Pooled GSK1265744
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
Overall Number of Participants Analyzed 15
Mean (90% Confidence Interval)
Unit of Measure: hr*µg/mL/mg
0.988
(0.841 to 1.135)
37.Secondary Outcome
Title Day 10 Cmax, C0 and Ctau at Different Doses for the Assessment of Dose Proportionality Using Power Model
Hide Description Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (Cmax, Ctau and C0) using the power model. The mean slope and corresponding 90% confidence interval has been presented.
Time Frame Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population.
Arm/Group Title Pooled GSK1265744
Hide Arm/Group Description:
Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451.
Overall Number of Participants Analyzed 15
Mean (90% Confidence Interval)
Unit of Measure: µg/mL/mg
Cmax
1.025
(0.903 to 1.147)
C0
0.936
(0.761 to 1.110)
Ctau
0.980
(0.808 to 1.151)
Time Frame Up to follow-up visit (Day 25±1)
Adverse Event Reporting Description Safety Population was used.
 
Arm/Group Title GSK1265744 30 mg GSK1265744 5 mg Placebo Optimized Therapy
Hide Arm/Group Description 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. Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days. Eligible participants received double-blind Placebo matching 5 mg GSK1265744 oral tablet once daily for 10 days. 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.
All-Cause Mortality
GSK1265744 30 mg GSK1265744 5 mg Placebo Optimized Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%)   0/2 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GSK1265744 30 mg GSK1265744 5 mg Placebo Optimized Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%)   0/2 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GSK1265744 30 mg GSK1265744 5 mg Placebo Optimized Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/8 (50.00%)   0/7 (0.00%)   2/2 (100.00%)   3/8 (37.50%) 
Eye disorders         
Ocular icterus  1  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders         
Nausea  1  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%)  1/8 (12.50%) 
Abdominal pain  1  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Constipation  1  0/8 (0.00%)  0/7 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Dyspepsia  1  2/8 (25.00%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
General disorders         
Fatigue  1  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Hepatobiliary disorders         
Jaundice  1  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Investigations         
Blood bilirubin increased  1  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  0/8 (0.00%)  0/7 (0.00%)  1/2 (50.00%)  0/8 (0.00%) 
Nervous system disorders         
Headache  1  2/8 (25.00%)  0/7 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Dizziness  1  3/8 (37.50%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Somnolence  1  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Psychiatric disorders         
Abnormal dreams  1  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Vascular disorders         
Hot flush  1  1/8 (12.50%)  0/7 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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