Trial Outcomes & Findings for Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults (NCT NCT03045861)

NCT ID: NCT03045861

Last Updated: 2020-03-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline (Day 1) to Day 21
• Results posted on: 2020-03-11

Participant Flow

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.

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.

Participant milestones

Measure	GSK2838232 20 mg 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.	GSK2838232 50 mg 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.	GSK2838232 100 mg 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.	GSK2838232 200 mg 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.
Part A (Up to 10 Days) STARTED	0	0	10	0
Part A (Up to 10 Days) COMPLETED	0	0	10	0
Part A (Up to 10 Days) NOT COMPLETED	0	0	0	0
Part B (Up to 10 Days) STARTED	7	8	0	8
Part B (Up to 10 Days) COMPLETED	7	8	0	8
Part B (Up to 10 Days) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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 n=33 Participants Total of all reporting groups
Age, Continuous	25.4 Years STANDARD_DEVIATION 5.59 • n=93 Participants	25.4 Years STANDARD_DEVIATION 9.74 • n=4 Participants	31.8 Years STANDARD_DEVIATION 10.66 • n=27 Participants	35.8 Years STANDARD_DEVIATION 14.87 • n=483 Participants	29.8 Years STANDARD_DEVIATION 11.23 • n=36 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	8 Participants n=4 Participants	9 Participants n=27 Participants	8 Participants n=483 Participants	32 Participants n=36 Participants
Race/Ethnicity, Customized Race, customized · American Indian or Alaska native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized Race, customized · Asian-South East Asian Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Race, customized · Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	8 Participants n=36 Participants
Race/Ethnicity, Customized Race, customized · Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Race, customized · White-White/Caucasian/European Heritage	5 Participants n=93 Participants	6 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants	20 Participants n=36 Participants
Race/Ethnicity, Customized Race, customized · Multiple-Black or African American and White	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 21

Population: ITT Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Maximum Decline From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)	-42095.14 Copies per milliliter Standard Deviation 37575.520	-49065.88 Copies per milliliter Standard Deviation 71339.743	-32947.50 Copies per milliliter Standard Deviation 54291.492	-33149.13 Copies per milliliter Standard Deviation 31785.663

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AEs	3 Participants	3 Participants	5 Participants	5 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any SAEs	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Carbon dioxide/bicarbonate; >32 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Carbon dioxide/bicarbonate; <18 mmol/L	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Urea; >9 mmol/L	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Creatinine; Change >44.2 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Glucose; >9 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Glucose; <3 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Potassium; >5.5 mmol/L	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Potassium; <3 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Sodium; >150 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Sodium; <130 mmol/L	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Troponin I; >=0.01 µg/L	7 Participants	8 Participants	10 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Hematocrit; >0.54	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Hematocrit; decline from Baseline >0.075	1 Participants	1 Participants	3 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Hemoglobin; >180	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Hemoglobin; decline from Baseline >25	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Lymphocytes; <0.8	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Neutrophils; <1.5	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Platelets; >550	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance Platelets; <100	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance White blood cells; >20	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance White blood cells; <3	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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).

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance Albumin; <30	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance Total Protein; ULN+15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance Total Protein; lower limit of normal (LLN)-15	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance ALT; >=2 times ULN	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance AST; >=2 times ULN	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance ALP; >=2 times ULN	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance Total bilirubin; >=1.5 times ULN	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance Direct bilirubin; >=0.3 times ULN	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Abnormal Urine Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Abnormal-clinically significant	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Abnormal-not clinically significant	5 Participants	6 Participants	8 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 1 (pre-dose)

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Vital Signs Data Outside Clinical Concern Range SBP; >Clinical concern range	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Data Outside Clinical Concern Range SBP; <Clinical concern range	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vital Signs Data Outside Clinical Concern Range DBP; >Clinical concern range	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vital Signs Data Outside Clinical Concern Range DBP; <Clinical concern range	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 22

Population: Safety Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants Who Were Administered Concomitant Medications	2 Participants	3 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1

Population: 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

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=9 Participants 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.	GSK2838232 100 mg n=9 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Area Under the Plasma Concentration Time Curve From Zero (Pre-dose) to 24 Hours (AUC[0 to 24]) for GSK2838232 on Day 1	187 Hours*nanograms per milliliter Geometric Coefficient of Variation 35.5	453 Hours*nanograms per milliliter Geometric Coefficient of Variation 60.4	966 Hours*nanograms per milliliter Geometric Coefficient of Variation 67.4	2752 Hours*nanograms per milliliter Geometric Coefficient of Variation 51.7

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1

Population: 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

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=9 Participants 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.	GSK2838232 100 mg n=9 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Maximum Observed Concentration (Cmax) for GSK2838232 on Day 1	12.65 Nanograms per milliliter Geometric Coefficient of Variation 36.4	32.39 Nanograms per milliliter Geometric Coefficient of Variation 61.0	65.62 Nanograms per milliliter Geometric Coefficient of Variation 76.7	190.0 Nanograms per milliliter Geometric Coefficient of Variation 44.3

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1

Population: 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

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=9 Participants 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.	GSK2838232 100 mg n=9 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Time to Maximum Observed Concentration (Tmax) for GSK2838232 on Day 1	4.033 Hours Interval 3.0 to 8.0	3.250 Hours Interval 2.0 to 8.0	6.000 Hours Interval 3.0 to 8.0	4.000 Hours Interval 2.0 to 6.0

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1

Population: 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

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=9 Participants 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.	GSK2838232 100 mg n=9 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Absorption Lag Time (Tlag) for GSK2838232 on Day 1	1.083 Hours Interval 0.5 to 1.58	1.000 Hours Interval 0.0 to 1.53	0.500 Hours Interval 0.0 to 1.5	0.500 Hours Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 24 hours post-dose on Day 1

Population: 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

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=9 Participants 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.	GSK2838232 100 mg n=9 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Concentration of GSK2838232 at 24 Hours Post-dose on Day 1	5.890 Nanograms per milliliter Geometric Coefficient of Variation 27.6	13.45 Nanograms per milliliter Geometric Coefficient of Variation 87.3	30.72 Nanograms per milliliter Geometric Coefficient of Variation 58.3	87.33 Nanograms per milliliter Geometric Coefficient of Variation 54.6

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0 to Tau]) for GSK2838232 on Day 10	590 Hours*nanograms per milliliter Geometric Coefficient of Variation 33.4	1024 Hours*nanograms per milliliter Geometric Coefficient of Variation 40.8	2727 Hours*nanograms per milliliter Geometric Coefficient of Variation 53.1	5664 Hours*nanograms per milliliter Geometric Coefficient of Variation 67.1

PRIMARY outcome

Timeframe: Pre dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Pre-dose Concentration (C0) of GSK2838232 on Day 10	20.02 Nanograms per milliliter Geometric Coefficient of Variation 28.8	36.66 Nanograms per milliliter Geometric Coefficient of Variation 39.8	75.31 Nanograms per milliliter Geometric Coefficient of Variation 57.0	155.5 Nanograms per milliliter Geometric Coefficient of Variation 64.5

PRIMARY outcome

Timeframe: 24 hours post-dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Concentration at End of Dosing Interval (Ctau) for GSK2838232 on Day 10	19.24 Nanograms per milliliter Geometric Coefficient of Variation 33.7	31.76 Nanograms per milliliter Geometric Coefficient of Variation 53.8	78.98 Nanograms per milliliter Geometric Coefficient of Variation 58.3	180.3 Nanograms per milliliter Geometric Coefficient of Variation 79.8

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Cmax for GSK2838232 on Day 10	32.65 Nanograms per milliliter Geometric Coefficient of Variation 30.8	56.40 Nanograms per milliliter Geometric Coefficient of Variation 33.0	157.9 Nanograms per milliliter Geometric Coefficient of Variation 54.0	306.5 Nanograms per milliliter Geometric Coefficient of Variation 59.2

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Apparent Oral Clearance of GSK2838232 Following Administration on Day 10	33.91 Liters per hour Geometric Coefficient of Variation 33.4	48.84 Liters per hour Geometric Coefficient of Variation 40.8	36.67 Liters per hour Geometric Coefficient of Variation 53.1	35.31 Liters per hour Geometric Coefficient of Variation 67.1

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=4 Participants 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.	GSK2838232 50 mg n=5 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Terminal Elimination Half-life (T1/2) of GSK2838232 Following Administration on Day 10	19.221 Hours Geometric Coefficient of Variation 17.1	16.298 Hours Geometric Coefficient of Variation 24.0	18.113 Hours Geometric Coefficient of Variation 18.3	16.351 Hours Geometric Coefficient of Variation 8.8

PRIMARY outcome

Timeframe: Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.

Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Tmax for GSK2838232 Following Administration on Day 10	6.000 Hours Interval 4.0 to 8.0	4.000 Hours Interval 2.0 to 8.05	6.000 Hours Interval 3.0 to 8.1	4.083 Hours Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 10 and 11

Population: Pharmacokinetic/Pharmacodynamic Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 AUC (0 to Tau)	-0.4979 log10 copies per milliliter Standard Deviation 0.44873	-1.1671 log10 copies per milliliter Standard Deviation 0.51996	-1.1745 log10 copies per milliliter Standard Deviation 0.45005	-1.5994 log10 copies per milliliter Standard Deviation 0.32718

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 10 and 11

Population: Pharmacokinetic/Pharmacodynamic Population.

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 Cmax	-0.4979 log10 copies per milliliter Standard Deviation 0.44873	-1.1671 log10 copies per milliliter Standard Deviation 0.51996	-1.1745 log10 copies per milliliter Standard Deviation 0.45005	-1.5994 log10 copies per milliliter Standard Deviation 0.32718

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 10 and 11

Population: Pharmacokinetic/Pharmacodynamic Population.

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 Ctau	-0.4979 log10 copies per milliliter Standard Deviation 0.44873	-1.1671 log10 copies per milliliter Standard Deviation 0.51996	-1.1745 log10 copies per milliliter Standard Deviation 0.45005	-1.5994 log10 copies per milliliter Standard Deviation 0.32718

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 11

Population: ITT Population. Only those participants with data available at the specified time points were analyzed.

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count to Day 11	-1.4 Cells per microliter Standard Deviation 95.26	52.0 Cells per microliter Standard Deviation 145.36	40.7 Cells per microliter Standard Deviation 94.47	11.1 Cells per microliter Standard Deviation 75.15

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 10 and 11

Population: Pharmacokinetic/Pharmacodynamic Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=31 Participants 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.	GSK2838232 50 mg 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.	GSK2838232 100 mg 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.	GSK2838232 200 mg 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.
Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 AUC (0 to Tau)	-0.003 cells/microliter/ng*h/mL Interval -0.016 to 0.01	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 10 and 11

Population: Pharmacokinetic/Pharmacodynamic Population

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

Outcome measures

Measure	GSK2838232 20 mg n=31 Participants 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.	GSK2838232 50 mg 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.	GSK2838232 100 mg 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.	GSK2838232 200 mg 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.
Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 Cmax	-0.067 cells/microliter/nanograms/milliliter Interval -0.32 to 0.187	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 10 and 11

Population: Pharmacokinetic/Pharmacodynamic Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=31 Participants 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.	GSK2838232 50 mg 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.	GSK2838232 100 mg 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.	GSK2838232 200 mg 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.
Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 Ctau	-0.079 cells/microliter/nanograms/milliliter Interval -0.451 to 0.292	—	—	—

SECONDARY outcome

Timeframe: Up to Day 11

Population: ITT Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Number of Participants With Emergent Drug Resistance Mutations RT/PR mutations	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Emergent Drug Resistance Mutations Reduced susceptibility to NRTIs, NNRTIs, PIs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Emergent Drug Resistance Mutations GSK2838232 phenotypic resistance	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Emergent Drug Resistance Mutations Treatment emergent A364A/V	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Population: Pharmacokinetic Population. Only participants with data available at the specified time points were analyzed.

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=7 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=7 Participants 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.
Accumulation Ratio for GSK2838232 R_AUC	3.149 Ratio Geometric Coefficient of Variation 42.2	2.004 Ratio Geometric Coefficient of Variation 34.4	3.229 Ratio Geometric Coefficient of Variation 46.1	2.211 Ratio Geometric Coefficient of Variation 27.2
Accumulation Ratio for GSK2838232 R_Cmax	2.580 Ratio Geometric Coefficient of Variation 45.1	1.498 Ratio Geometric Coefficient of Variation 40.0	2.753 Ratio Geometric Coefficient of Variation 43.4	1.668 Ratio Geometric Coefficient of Variation 26.5
Accumulation Ratio for GSK2838232 R_Ctau	3.267 Ratio Geometric Coefficient of Variation 41.2	2.118 Ratio Geometric Coefficient of Variation 43.9	3.038 Ratio Geometric Coefficient of Variation 64.8	2.210 Ratio Geometric Coefficient of Variation 45.1

SECONDARY outcome

Timeframe: pre dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Days 1 and 10

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category )

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.

Outcome measures

Measure	GSK2838232 20 mg n=33 Participants 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.	GSK2838232 50 mg 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.	GSK2838232 100 mg 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.	GSK2838232 200 mg 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.
Dose Proportionality of GSK2838232 AUC(0-24); Day 1	1.157 slope of log dose Interval 0.971 to 1.343	—	—	—
Dose Proportionality of GSK2838232 Cmax; Day 1	1.158 slope of log dose Interval 0.968 to 1.349	—	—	—
Dose Proportionality of GSK2838232 C24; Day 1	1.170 slope of log dose Interval 0.968 to 1.371	—	—	—
Dose Proportionality of GSK2838232 AUC (0 to tau); Day 10	1.012 slope of log dose Interval 0.835 to 1.19	—	—	—
Dose Proportionality of GSK2838232 Cmax; Day 10	1.013 slope of log dose Interval 0.845 to 1.181	—	—	—
Dose Proportionality of GSK2838232 Ctau; Day 10	0.988 slope of log dose Interval 0.787 to 1.19	—	—	—

SECONDARY outcome

Timeframe: Pre-dose on Days 2, 3, 4, 5, 8, 9, 10 and 11

Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=9 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 2; n=7, 9, 9, 8	6.08 Nanograms per milliliter Standard Deviation 1.695	16.39 Nanograms per milliliter Standard Deviation 9.002	34.17 Nanograms per milliliter Standard Deviation 13.990	96.94 Nanograms per milliliter Standard Deviation 44.319
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 3; n=7, 8, 10, 8	13.99 Nanograms per milliliter Standard Deviation 5.576	29.03 Nanograms per milliliter Standard Deviation 11.870	51.27 Nanograms per milliliter Standard Deviation 25.971	163.98 Nanograms per milliliter Standard Deviation 91.368
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 4; n=7, 7, 10, 8	14.66 Nanograms per milliliter Standard Deviation 5.771	31.80 Nanograms per milliliter Standard Deviation 13.319	64.49 Nanograms per milliliter Standard Deviation 26.710	176.28 Nanograms per milliliter Standard Deviation 96.684
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 5; n=4, 6, 10, 7	15.03 Nanograms per milliliter Standard Deviation 3.308	34.35 Nanograms per milliliter Standard Deviation 15.626	76.14 Nanograms per milliliter Standard Deviation 35.179	206.29 Nanograms per milliliter Standard Deviation 69.533
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 8; n=7, 8, 10, 8	19.72 Nanograms per milliliter Standard Deviation 7.139	43.14 Nanograms per milliliter Standard Deviation 16.664	86.39 Nanograms per milliliter Standard Deviation 43.382	187.16 Nanograms per milliliter Standard Deviation 110.304
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 9; n=7, 6, 10, 8	20.53 Nanograms per milliliter Standard Deviation 6.760	43.83 Nanograms per milliliter Standard Deviation 18.691	89.32 Nanograms per milliliter Standard Deviation 40.407	206.75 Nanograms per milliliter Standard Deviation 124.166
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 10; n=7, 7, 10, 8	20.76 Nanograms per milliliter Standard Deviation 6.426	39.19 Nanograms per milliliter Standard Deviation 16.502	84.52 Nanograms per milliliter Standard Deviation 39.940	189.05 Nanograms per milliliter Standard Deviation 107.636
Pre-morning Dose Concentrations (C0) on Day 2 Through 11 Day 11; n=7, 7, 10, 8	20.16 Nanograms per milliliter Standard Deviation 6.828	35.09 Nanograms per milliliter Standard Deviation 16.038	89.87 Nanograms per milliliter Standard Deviation 49.195	219.23 Nanograms per milliliter Standard Deviation 133.552

SECONDARY outcome

Timeframe: Pre-dose on Days 8, 9 and 10

Population: Pharmacokinetic Population

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.

Outcome measures

Measure	GSK2838232 20 mg n=7 Participants 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.	GSK2838232 50 mg n=8 Participants 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.	GSK2838232 100 mg n=10 Participants 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.	GSK2838232 200 mg n=8 Participants 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.
Steady State Assessment of Plasma Pre-dose Concentrations by Treatment	0.924 Ratio Interval 0.778 to 1.097	0.999 Ratio Interval 0.839 to 1.189	0.958 Ratio Interval 0.83 to 1.106	0.961 Ratio Interval 0.818 to 1.128

Adverse Events

GSK2838232 20 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GSK2838232 50 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GSK2838232 100 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK2838232 200 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GSK2838232 20 mg n=7 participants at risk 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.	GSK2838232 50 mg n=8 participants at risk 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.	GSK2838232 100 mg n=10 participants at risk 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.	GSK2838232 200 mg n=8 participants at risk 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.
Nervous system disorders Headache	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	20.0% 2/10 • Number of events 2 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Nervous system disorders Dizziness	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Nervous system disorders Head discomfort	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Nervous system disorders Presyncope	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Nervous system disorders Somnolence	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	10.0% 1/10 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Skin and subcutaneous tissue disorders Acne	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Skin and subcutaneous tissue disorders Rash	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	10.0% 1/10 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Infections and infestations Urinary tract infection	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Infections and infestations Viral upper respiratory tract infection	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Gastrointestinal disorders Toothache	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	10.0% 1/10 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
General disorders Fatigue	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
General disorders Medical device site dermatitis	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
General disorders Medical device site reaction	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Psychiatric disorders Abnormal dreams	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Psychiatric disorders Anxiety	14.3% 1/7 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	10.0% 1/10 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/10 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	12.5% 1/8 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/7 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	10.0% 1/10 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population	0.00% 0/8 • SAEs and non-serious AEs were collected from the start of study treatment until Day 22 SAEs and non-serious AEs were collected in the Safety Population

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER