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Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults

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.
 
ClinicalTrials.gov Identifier: NCT03045861
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : May 29, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infection, Human Immunodeficiency Virus
HIV Infections
Interventions Drug: GSK2838232
Drug: Cobicistat
Enrollment 33
Recruitment Details This was a dose ranging study to evaluate the antiviral effect, safety, tolerability and pharmacokinetics of cobicistat-boosted GSK2838232 monotherapy over 10 days in human immunodeficiency virus-1 (HIV-1) infected participants.
Pre-assignment Details A total of 85 participants were screened across 21 sites in the United States and Canada of which 52 participants failed screening. Thirty three participants were enrolled from 15 sites in the United States and Canada.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Period Title: Part A (Up to 10 Days)
Started 0 0 10 0
Completed 0 0 10 0
Not Completed 0 0 0 0
Period Title: Part B (Up to 10 Days)
Started 7 8 0 8
Completed 7 8 0 8
Not Completed 0 0 0 0
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg Total
Hide Arm/Group Description Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Total of all reporting groups
Overall Number of Baseline Participants 7 8 10 8 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 8 participants 10 participants 8 participants 33 participants
25.4  (5.59) 25.4  (9.74) 31.8  (10.66) 35.8  (14.87) 29.8  (11.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 10 participants 8 participants 33 participants
Female
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
1
   3.0%
Male
7
 100.0%
8
 100.0%
9
  90.0%
8
 100.0%
32
  97.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race, customized Number Analyzed 7 participants 8 participants 10 participants 8 participants 33 participants
American Indian or Alaska native
1
  14.3%
0
   0.0%
1
  10.0%
0
   0.0%
2
   6.1%
Asian-South East Asian Heritage
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.0%
Black or African American
0
   0.0%
1
  12.5%
5
  50.0%
2
  25.0%
8
  24.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   3.0%
White-White/Caucasian/European Heritage
5
  71.4%
6
  75.0%
4
  40.0%
5
  62.5%
20
  60.6%
Multiple-Black or African American and White
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   3.0%
1.Primary Outcome
Title Maximum Decline From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
Hide Description Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. An HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies/milliliter (ultrasensitive assay) was used for post-baseline assessments. Baseline value was the value at latest pre-dose assessment. The maximum decline was determined using change from Baseline in plasma HIV-RNA values at each time point. The analysis was performed on Intent To Treat (ITT) Population which comprised of all participants who met study criteria and were enrolled into the study with documented evidence of having received at least 1 dose of treatment and at least one post-Baseline HIV-1 RNA measurement.
Time Frame Baseline (Day 1) to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Mean (Standard Deviation)
Unit of Measure: Copies per milliliter
-42095.14  (37575.520) -49065.88  (71339.743) -32947.50  (54291.492) -33149.13  (31785.663)
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as 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; is a congenital anomaly/birth defect; other important medical events; is associated with liver injury and impaired liver function. Safety Population comprised of all participants who received at least one dose of study treatment.
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
3
  42.9%
3
  37.5%
5
  50.0%
5
  62.5%
Any SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance
Hide Description Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: carbon dioxide/bicarbonate (low: <18 millimoles per liter [mmol/L] and high: >32 mmol/L); urea (high: >9 mmol/L); creatinine (high: change from Baseline >44.2 micromoles per liter [µmol/L]), glucose (low: <3 and high: >9 mmol/L); potassium (low: <3 and high: >5.5 mmol/L); troponin I (high: >=0.01 micrograms per liter [µg/L]) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for any visit post-Baseline is reported.
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
Carbon dioxide/bicarbonate; >32 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Carbon dioxide/bicarbonate; <18 mmol/L
0
   0.0%
0
   0.0%
3
  30.0%
0
   0.0%
Urea; >9 mmol/L
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; Change >44.2 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose; >9 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose; <3 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; >5.5 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
Potassium; <3 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; >150 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; <130 mmol/L
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Troponin I; >=0.01 µg/L
7
 100.0%
8
 100.0%
10
 100.0%
8
 100.0%
4.Primary Outcome
Title Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance
Hide Description Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: >0.54 proportion of red blood cells in blood); hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8x10^9 cells/L); neutrophil count (low: <1.5x10^9 cells/L); platelet count (low: <100x10^9 cells/L and high: >550x10^9 cells/L); white blood cells (low: <3x10^9 cells/L and high: >20x10^9cells/L). Data for any visit post-Baseline is reported.
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
Hematocrit; >0.54
0
   0.0%
0
   0.0%
1
  10.0%
1
  12.5%
Hematocrit; decline from Baseline >0.075
1
  14.3%
1
  12.5%
3
  30.0%
0
   0.0%
Hemoglobin; >180
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin; decline from Baseline >25
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
Lymphocytes; <0.8
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils; <1.5
1
  14.3%
0
   0.0%
3
  30.0%
1
  12.5%
Platelets; >550
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets; <100
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
White blood cells; >20
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White blood cells; <3
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
5.Primary Outcome
Title Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance
Hide Description Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: albumin (low: <30 g/L), total protein (low: <15 and high: >15 g/L), alanine aminotransferase (high: >=2 times upper limit of normal [ULN]); aspartate aminotransferase (high: >=2 times ULN); alkaline phosphatase (high: >=2 times ULN); total bilirubin (high: >=1.5 times ULN); direct bilirubin (high: >0.3 times ULN).
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
Albumin; <30
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Protein; ULN+15
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Protein; lower limit of normal (LLN)-15
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT; >=2 times ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST; >=2 times ULN
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
ALP; >=2 times ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total bilirubin; >=1.5 times ULN
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
Direct bilirubin; >=0.3 times ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Abnormal Urine Parameters
Hide Description Urine samples were collected for the assessment of following urine parameters by dipstick method: pH, glucose, protein, blood and ketones. The number of participants with abnormal urine parameters is presented.
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal ECG findings at worst-case post Baseline is presented.
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal-not clinically significant
5
  71.4%
6
  75.0%
8
  80.0%
4
  50.0%
Abnormal-clinically significant
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Vital Signs Data Outside Clinical Concern Range
Hide Description Vital signs were measured in a semi-supine position after 5 minutes rest and included temperature, systolic and diastolic blood pressure and pulse rate. The clinical concern range for vital signs were: systolic blood pressure (SBP) (low: <85 and high: >160 millimeters of mercury [mmHg]) and diastolic blood pressure (DBP) (low: <45 and high: >100 mmHg). Number of participants with vital signs data outside clinical concern range is presented.
Time Frame Day 1 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
SBP; >Clinical concern range
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
SBP; <Clinical concern range
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
DBP; >Clinical concern range
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
DBP; <Clinical concern range
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Participants Who Were Administered Concomitant Medications
Hide Description Concomitant medications (prescription and non-prescription) were administered only as medically necessary during the study. Number of participants who received any concomitant medications is presented.
Time Frame Up to Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
3
  37.5%
3
  30.0%
3
  37.5%
10.Primary Outcome
Title Area Under the Plasma Concentration Time Curve From Zero (Pre-dose) to 24 Hours (AUC[0 to 24]) for GSK2838232 on Day 1
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232. The analysis was performed on Pharmacokinetic Population which comprised of participants who received GSK2838232 and underwent plasma pharmacokinetic sampling during the study.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 9 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanograms per milliliter
187
(35.5%)
453
(60.4%)
966
(67.4%)
2752
(51.7%)
11.Primary Outcome
Title Maximum Observed Concentration (Cmax) for GSK2838232 on Day 1
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 9 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
12.65
(36.4%)
32.39
(61.0%)
65.62
(76.7%)
190.0
(44.3%)
12.Primary Outcome
Title Time to Maximum Observed Concentration (Tmax) for GSK2838232 on Day 1
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 9 9 8
Median (Full Range)
Unit of Measure: Hours
4.033
(3.00 to 8.00)
3.250
(2.00 to 8.00)
6.000
(3.00 to 8.00)
4.000
(2.00 to 6.00)
13.Primary Outcome
Title Absorption Lag Time (Tlag) for GSK2838232 on Day 1
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 9 9 8
Median (Full Range)
Unit of Measure: Hours
1.083
(0.50 to 1.58)
1.000
(0.00 to 1.53)
0.500
(0.00 to 1.50)
0.500
(0.00 to 1.00)
14.Primary Outcome
Title Concentration of GSK2838232 at 24 Hours Post-dose on Day 1
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame 24 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 9 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
5.890
(27.6%)
13.45
(87.3%)
30.72
(58.3%)
87.33
(54.6%)
15.Primary Outcome
Title Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0 to Tau]) for GSK2838232 on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanograms per milliliter
590
(33.4%)
1024
(40.8%)
2727
(53.1%)
5664
(67.1%)
16.Primary Outcome
Title Pre-dose Concentration (C0) of GSK2838232 on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
20.02
(28.8%)
36.66
(39.8%)
75.31
(57.0%)
155.5
(64.5%)
17.Primary Outcome
Title Concentration at End of Dosing Interval (Ctau) for GSK2838232 on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame 24 hours post-dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
19.24
(33.7%)
31.76
(53.8%)
78.98
(58.3%)
180.3
(79.8%)
18.Primary Outcome
Title Cmax for GSK2838232 on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter
32.65
(30.8%)
56.40
(33.0%)
157.9
(54.0%)
306.5
(59.2%)
19.Primary Outcome
Title Apparent Oral Clearance of GSK2838232 Following Administration on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
33.91
(33.4%)
48.84
(40.8%)
36.67
(53.1%)
35.31
(67.1%)
20.Primary Outcome
Title Terminal Elimination Half-life (T1/2) of GSK2838232 Following Administration on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 4 5 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
19.221
(17.1%)
16.298
(24.0%)
18.113
(18.3%)
16.351
(8.8%)
21.Primary Outcome
Title Tmax for GSK2838232 Following Administration on Day 10
Hide Description Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.
Time Frame Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Median (Full Range)
Unit of Measure: Hours
6.000
(4.00 to 8.00)
4.000
(2.00 to 8.05)
6.000
(3.00 to 8.10)
4.083
(2.00 to 6.00)
22.Secondary Outcome
Title Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 AUC (0 to Tau)
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Change from Baseline is the value at indicated time point minus Baseline value. Statistical analysis for relationship between pharmacokinetic parameters (AUC) and pharmacodynamic measures (Change from Baseline in plasma HIV-1 RNA) was explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), pharmacokinetic parameter value that attains 50% of the maximal effect (ED50) and residual variability (s2e). Pharmacokinetic/Pharmacodynamic Population comprised of participants who met criteria for Per-Protocol (all participants who met study criteria and are enrolled into the study with documented evidence of having received all doses and all post-baseline HIV-1 RNA measurement, with exceptions of those who have at least one major protocol deviation) and Pharmacokinetic Population analysis sets and who underwent pharmacodynamic sampling during study.
Time Frame Baseline (Day 1), Days 10 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic/Pharmacodynamic Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 8
Mean (Standard Deviation)
Unit of Measure: log10 copies per milliliter
-0.4979  (0.44873) -1.1671  (0.51996) -1.1745  (0.45005) -1.5994  (0.32718)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Emax
Estimated Value -1.822
Confidence Interval (2-Sided) 95%
-2.333 to 1.310
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ED50
Estimated Value 1020.755
Confidence Interval (2-Sided) 95%
100.786 to 1940.724
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter s2e
Estimated Value 0.200
Confidence Interval (2-Sided) 95%
0.095 to 0.306
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 Cmax
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Change from Baseline is the value at indicated time point minus Baseline value. Statistical analysis for the relationship between pharmacokinetic parameters (Cmax) and pharmacodynamic measures (change from Baseline in log10 plasma HIV-1 RNA) was explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), pharmacokinetic parameter value that attains the 50% of the maximal effect (ED50) and s2e.
Time Frame Baseline (Day 1), Days 10 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic/Pharmacodynamic Population.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 8
Mean (Standard Deviation)
Unit of Measure: log10 copies per milliliter
-0.4979  (0.44873) -1.1671  (0.51996) -1.1745  (0.45005) -1.5994  (0.32718)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Emax
Estimated Value -1.801
Confidence Interval (2-Sided) 95%
-2.319 to -1.283
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ED50
Estimated Value 55.572
Confidence Interval (2-Sided) 95%
3.565 to 107.579
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter s2e
Estimated Value 0.206
Confidence Interval (2-Sided) 95%
0.097 to 0.314
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 Ctau
Hide Description Plasma samples were collected for quantitative analysis of HIV-1 RNA. Change from Baseline is the value at indicated time point minus Baseline value. Statistical analysis for the relationship between pharmacokinetic parameters (Ctau) and pharmacodynamic measures (change from Baseline in log10 plasma HIV-1 RNA) was explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), pharmacokinetic parameter value that attains the 50% of the maximal effect (ED50) and s2e.
Time Frame Baseline (Day 1), Days 10 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic/Pharmacodynamic Population.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 8
Mean (Standard Deviation)
Unit of Measure: log10 copies per milliliter
-0.4979  (0.44873) -1.1671  (0.51996) -1.1745  (0.45005) -1.5994  (0.32718)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Emax
Estimated Value -1.846
Confidence Interval (2-Sided) 95%
-2.352 to -1.340
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ED50
Estimated Value 32.415
Confidence Interval (2-Sided) 95%
4.687 to 60.143
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2838232 20 mg, GSK2838232 50 mg, GSK2838232 100 mg, GSK2838232 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter s2e
Estimated Value 0.200
Confidence Interval (2-Sided) 95%
0.094 to 0.305
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count to Day 11
Hide Description CD4+ cell counts were assessed by flow cytometry. Baseline value is the latest pre-dose assessment value. Change from Baseline is calculated as the post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1) and Day 11
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ITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 8
Mean (Standard Deviation)
Unit of Measure: Cells per microliter
-1.4  (95.26) 52.0  (145.36) 40.7  (94.47) 11.1  (75.15)
26.Secondary Outcome
Title Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 AUC (0 to Tau)
Hide Description The relationship between pharmacokinetic parameters (AUC) and pharmacodynamic measures (change from Baseline CD4+ cell count) was explored using a frequentist linear model. The model parameters estimated included slope and intercept. The estimate (slope) along with 95% confidence interval is presented.
Time Frame Baseline (Day 1), Days 10 and 11
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Hide Analysis Population Description
Pharmacokinetic/Pharmacodynamic Population
Arm/Group Title Participants Receiving GSK2838232
Hide Arm/Group Description:
Participants who received GSK2838232 at doses of 20 mg, 50 mg, 100 mg and 200 mg were included.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cells/microliter/ng*h/mL
-0.003
(-0.016 to 0.010)
27.Secondary Outcome
Title Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 Cmax
Hide Description The relationship between pharmacokinetic parameters (Cmax) and pharmacodynamic measures (change from Baseline CD4+ cell count) was explored using a frequentist linear model. The model parameters estimated included slope and intercept. The estimate (slope) along with 95% confidence interval is presented
Time Frame Baseline (Day 1), Days 10 and 11
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Hide Analysis Population Description
Pharmacokinetic/Pharmacodynamic Population
Arm/Group Title Participants Receiving GSK2838232
Hide Arm/Group Description:
Participants who received GSK2838232 at doses of 20 mg, 50 mg, 100 mg and 200 mg were included.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cells/microliter/nanograms/milliliter
-0.067
(-0.320 to 0.187)
28.Secondary Outcome
Title Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 Ctau
Hide Description The relationship between pharmacokinetic parameters (Ctau) and pharmacodynamic measures (change from Baseline CD4+ cell count) was explored using a frequentist linear model. The model parameters estimated included slope and intercept. The estimate (slope) along with 95% confidence interval is presented.
Time Frame Baseline (Day 1), Days 10 and 11
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Hide Analysis Population Description
Pharmacokinetic/Pharmacodynamic Population
Arm/Group Title Participants Receiving GSK2838232
Hide Arm/Group Description:
Participants who received GSK2838232 at doses of 20 mg, 50 mg, 100 mg and 200 mg were included.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cells/microliter/nanograms/milliliter
-0.079
(-0.451 to 0.292)
29.Secondary Outcome
Title Number of Participants With Emergent Drug Resistance Mutations
Hide Description Plasma samples were collected to evaluate treatment-emergent genotypic mutations in Gag, reverse transcriptase (RT) and protease (PR) and to assess phenotypic resistance to GSK2838232 and RT and PR drugs. Number of participants with treatment emergent RT/PR mutations, reduced susceptibility to nucleoside/nucleotide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI), treatment emergent maturation inhibitor A364A/V and GSK2838232 phenotypic resistance is presented.
Time Frame Up to Day 11
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Hide Analysis Population Description
ITT Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
RT/PR mutations
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reduced susceptibility to NRTIs, NNRTIs, PIs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
GSK2838232 phenotypic resistance
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
Treatment emergent A364A/V
0
   0.0%
1
  12.5%
1
  10.0%
0
   0.0%
30.Secondary Outcome
Title Accumulation Ratio for GSK2838232
Hide Description Serial blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232. The accumulation ratios were calculated as R_AUC=AUC(0-tau) Day 10/AUC(0-24) Day 1; R_Cmax=Cmax Day 10/Cmax Day 1 and R_Ctau=Ctau Day 10/C24 Day 1.
Time Frame pre dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Days 1 and 10; pre-dose on Days 3, 4, 5, 8 and 9; Days 12 and 14
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Hide Analysis Population Description
Pharmacokinetic Population. Only participants with data available at the specified time points were analyzed.
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 7 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
R_AUC
3.149
(42.2%)
2.004
(34.4%)
3.229
(46.1%)
2.211
(27.2%)
R_Cmax
2.580
(45.1%)
1.498
(40.0%)
2.753
(43.4%)
1.668
(26.5%)
R_Ctau
3.267
(41.2%)
2.118
(43.9%)
3.038
(64.8%)
2.210
(45.1%)
31.Secondary Outcome
Title Dose Proportionality of GSK2838232
Hide Description Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232. Dose proportionality was assessed using a fixed effects power model. Estimated slope and 90% confidence interval is presented.
Time Frame pre dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Days 1 and 10
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category )
Arm/Group Title Participants Receiving GSK2838232
Hide Arm/Group Description:
Participants who received GSK2838232 at doses of 20 mg, 50 mg, 100 mg and 200 mg were included.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: slope of log dose
AUC(0-24); Day 1
1.157
(0.971 to 1.343)
Cmax; Day 1
1.158
(0.968 to 1.349)
C24; Day 1
1.170
(0.968 to 1.371)
AUC (0 to tau); Day 10
1.012
(0.835 to 1.190)
Cmax; Day 10
1.013
(0.845 to 1.181)
Ctau; Day 10
0.988
(0.787 to 1.190)
32.Secondary Outcome
Title Pre-morning Dose Concentrations (C0) on Day 2 Through 11
Hide Description Blood samples were collected for pharmacokinetic analysis of GSK2838232. The pre-morning dose concentrations for Days 2 to 11 is presented. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Days 1 and 2 and with GSK2838232 100 mg for Days 3 to 10.
Time Frame Pre-dose on Days 2, 3, 4, 5, 8, 9, 10 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 9 10 8
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter
Day 2; n=7, 9, 9, 8 Number Analyzed 7 participants 9 participants 9 participants 8 participants
6.08  (1.695) 16.39  (9.002) 34.17  (13.990) 96.94  (44.319)
Day 3; n=7, 8, 10, 8 Number Analyzed 7 participants 8 participants 10 participants 8 participants
13.99  (5.576) 29.03  (11.870) 51.27  (25.971) 163.98  (91.368)
Day 4; n=7, 7, 10, 8 Number Analyzed 7 participants 7 participants 10 participants 8 participants
14.66  (5.771) 31.80  (13.319) 64.49  (26.710) 176.28  (96.684)
Day 5; n=4, 6, 10, 7 Number Analyzed 4 participants 6 participants 10 participants 7 participants
15.03  (3.308) 34.35  (15.626) 76.14  (35.179) 206.29  (69.533)
Day 8; n=7, 8, 10, 8 Number Analyzed 7 participants 8 participants 10 participants 8 participants
19.72  (7.139) 43.14  (16.664) 86.39  (43.382) 187.16  (110.304)
Day 9; n=7, 6, 10, 8 Number Analyzed 7 participants 6 participants 10 participants 8 participants
20.53  (6.760) 43.83  (18.691) 89.32  (40.407) 206.75  (124.166)
Day 10; n=7, 7, 10, 8 Number Analyzed 7 participants 7 participants 10 participants 8 participants
20.76  (6.426) 39.19  (16.502) 84.52  (39.940) 189.05  (107.636)
Day 11; n=7, 7, 10, 8 Number Analyzed 7 participants 7 participants 10 participants 8 participants
20.16  (6.828) 35.09  (16.038) 89.87  (49.195) 219.23  (133.552)
33.Secondary Outcome
Title Steady State Assessment of Plasma Pre-dose Concentrations by Treatment
Hide Description A linear mixed model using Day, treatment and Day by treatment as fixed effects and participant as a random effect on the log-transformed pre-dose values was performed to evaluate if steady state was achieved using the Helmert transformation approach. The comparison was done as Day 8 versus the average of Days 9 and 10 values. The ratio of geometric least square mean for Day 8 versus average of Days 9 and 10 values is presented along with 95% confidence interval.
Time Frame Pre-dose on Days 8, 9 and 10
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Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description:
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
Overall Number of Participants Analyzed 7 8 10 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
0.924
(0.778 to 1.097)
0.999
(0.839 to 1.189)
0.958
(0.830 to 1.106)
0.961
(0.818 to 1.128)
Time Frame SAEs and non-serious AEs were collected from the start of study treatment until Day 22
Adverse Event Reporting Description SAEs and non-serious AEs were collected in the Safety Population
 
Arm/Group Title GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Hide Arm/Group Description Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 20 milligrams (mg) and 150 mg cobicistat once daily with a light breakfast meal and 240 milliliters (mL) of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 50 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 100 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10. Eligible HIV-1 infected participants were administered a single oral dose of GSK2838232 200 mg and 150 mg cobicistat once daily with a light breakfast meal and 240 mL of water from Day 1 to Day 10.
All-Cause Mortality
GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/8 (0.00%)      0/10 (0.00%)      0/8 (0.00%)    
Hide Serious Adverse Events
GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/8 (0.00%)      0/10 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GSK2838232 20 mg GSK2838232 50 mg GSK2838232 100 mg GSK2838232 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      3/8 (37.50%)      5/10 (50.00%)      5/8 (62.50%)    
Blood and lymphatic system disorders         
Lymphadenopathy  1  0/7 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Toothache  1  0/7 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0
General disorders         
Fatigue  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Medical device site dermatitis  1  0/7 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0
Medical device site reaction  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  0/7 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0
Urinary tract infection  1  0/7 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1
Viral upper respiratory tract infection  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Myalgia  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Pain in extremity  1  0/7 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders         
Headache  1  0/7 (0.00%)  0 0/8 (0.00%)  0 2/10 (20.00%)  2 0/8 (0.00%)  0
Dizziness  1  0/7 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1
Head discomfort  1  0/7 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1
Presyncope  1  0/7 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1
Somnolence  1  0/7 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0
Psychiatric disorders         
Abnormal dreams  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Anxiety  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/7 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0
Nasal congestion  1  0/7 (0.00%)  0 0/8 (0.00%)  0 0/10 (0.00%)  0 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders         
Acne  1  0/7 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0
Night sweats  1  0/7 (0.00%)  0 1/8 (12.50%)  1 0/10 (0.00%)  0 0/8 (0.00%)  0
Pruritus  1  1/7 (14.29%)  1 0/8 (0.00%)  0 0/10 (0.00%)  0 0/8 (0.00%)  0
Rash  1  0/7 (0.00%)  0 0/8 (0.00%)  0 1/10 (10.00%)  1 0/8 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03045861    
Other Study ID Numbers: 200911
First Submitted: January 12, 2017
First Posted: February 8, 2017
Results First Submitted: April 1, 2019
Results First Posted: May 29, 2019
Last Update Posted: March 11, 2020