| Primary | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) to Day 11 | Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a lower limit of detection (LLOD) of 50 copies/milliliter (mL) (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Intent-to-treat (ITT) population comprised of all participants who met study criteria and randomized into study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post-baseline HIV-1 RNA measurement. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline (Day 1) and Day 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-2.169± 0.2405
- OG001-0.092± 0.1499
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | <0.001 | Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate. | Mean Difference (Net) | -2.090 | | | 2-Sided | 95 | -2.547 | -1.632 | | | | | Superiority or Other | | |
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| Primary | GSK1265744 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments(AUC[0-24]) | Blood samples for PK analysis of AUC(0-24) of GSK1265744 was collected on Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. | PK Summary Population included participants with evaluable PK profile of GSK1265744 on Day 10. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram per milliliter (hr*µg/mL) | | Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Dose Administration on Day 1: Concentration at 24 Hours Post Dose (C24) | Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. | PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter (µg/mL) | | Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Dose Administration on Day 10: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) | Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. | PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*µg/mL | | Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Dose Administration on Day 10: Predose Concentration (C0), Concentration at End of Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin) | Blood samples for PK analysis of C0, Ctau and Cmin of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. | PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Maximum Observed Concentration (Cmax) | Blood samples for PK analysis of Cmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. | PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Time to Cmax (Tmax) | Blood samples for PK analysis of tmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. | PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Median | Full Range | Hour | | Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Terminal Half-life (t1/2) and Absorption Lag Time (Tlag) | PK sampling was planned to be collected up to 24 hours only on Day 1 and Day 10. The data for this outcome measure was however not collected. | PK Summary Population. Data for this outcome measure was not collected. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | | | | | Day 1 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | GSK1265744 PK Parameters Following Last Repeat Administration on Day 10: Apparent Clearance Following Oral Dosing (CL/F) | Blood samples for PK analysis of CL/F of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. | PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/hr) | | Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
| |
| Primary | Number of Participants With Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or is associated with liver injury and impaired liver function. | Safety population was defined as all participants who were randomized into the study with documented evidence of having received at least 1 dose of randomized treatment. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Count of Participants | | Participants | | Day 1 to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
|
| Primary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC- Absolute Neutrophil Count), White Blood Cell Count | Blood samples for assessment of hematology parameters of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC- absolute neutrophil count) and white blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Thousand cells per microliter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Hematology Parameters: Hemoglobin | Blood samples for assessment of hematology parameter of hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Grams per deciliter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Hematology Parameters: Mean Corpuscle Hemoglobin | Blood samples for assessment of hematology parameter of mean corpuscle hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Picogram | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Hematology Parameters: Mean Corpuscle Volume | Blood samples for assessment of hematology parameter of mean corpuscle volume was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Hematology Parameters: Platelet Count | Blood samples for assessment of hematology parameter of platelet count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Cells per cubic millimeter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Hematology Parameters: Red Blood Cell Count | Blood samples for assessment of hematology parameter of red blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Million cells per microliter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Hematology Parameters: Reticulocytes | Blood samples for assessment of hematology parameter of reticulocytes was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Giga cells per liter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Clinical Chemistry Data: Albumin, Total Protein | Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Grams per deciliter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Clinical Chemistry Data: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Lipase | Blood samples for assessment of clinical chemistry parameters of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and lipase was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety Population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Units per liter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Direct Bilirubin, Total Bilirubin, Calcium, Cholesterol, Creatinine, Glucose, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, Triglycerides, Urea/Blood Urea Nitrogen | Blood samples for assessment of clinical chemistry parameters of direct bilirubin, total bilirubin, calcium, cholesterol, creatinine, glucose, HDL cholesterol direct, LDL cholesterol calculation, triglycerides,Urea/BUN was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Milligrams per deciliter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Clinical Chemistry Data: Chloride, Carbon Dioxide Content/Bicarbonate, Magnesium, Sodium, Potassium | Blood samples for assessment of clinical chemistry parameters of chloride, carbon dioxide content/bicarbonate, magnesium, sodium and potassium was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Milliequivalents per liter | | Baseline (Day 1) and Day 3, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Number of Participants With Urinalysis Data | Samples for urinalysis assessment was collected on Day 1, Day 3 and Day 10. Urinalysis parameters included urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine pH, urine protein, urine specific gravity and urine leukocyte esterase test for detecting white blood cell. | Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Count of Participants | | Participants | | Day 1 to Day 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Vital Sign: Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Vital Sign: Heart Rate | Heart rate was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Primary | Change From Baseline in Electrocardiogram (ECG) Parameters | All ECGs were obtained after a minimum 10 minute rest in a semi-supine position. The 12-lead ECGs were obtained at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10 using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and Bazett's correction (QTcB) and Fridericia correction (QTcF) intervals. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Milliseconds (msec) | | Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Secondary | Change From Baseline in Plasma HIV-1 RNA | Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA were collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | ITT population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline (Day 1 pre-dose) and Day 1 (post dose), 2, 3, 4, 7, 8, 9, 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Secondary | Change From Baseline in Plasma HIV-1 RNA to Nadir Over 11 Days | Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Nadir was the maximum change from Baseline in plasma HIV-1 RNA. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline (Day 1) and Day 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Secondary | Plasma HIV-1 RNA Rate of Decline (Slope) Over 11 Days | Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Estimated mean rate of decline (i.e., slope of day) with corresponding 90% confidence interval was provided for each treatment. | ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | 90% Confidence Interval | log10 copies per mL per day | | Up to Day 10 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
| |
| Secondary | Number of Participants With HIV-1 RNA<400 Copies/mL | Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented. | ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Count of Participants | | Participants | | Up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
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| Secondary | Number of Participants With HIV-1 RNA<50 Copies/mL | Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented. | ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Count of Participants | | Participants | | Up to Day 11 | | | | ID | Title | Description |
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| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
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| Secondary | Change From Baseline in CD4+ Cell Count to Day 11 | Whole venous blood samples was obtained from each participant for the analysis of lymphocyte subsets by flow cytometry on Day 1 and Day 11. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. | ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | Cells per cubic millimeter | | Baseline (Day 1) and Day 11 | | | | ID | Title | Description |
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| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. | | OG001 | Placebo | Eligible participants received double-blind matching Placebo oral tablet once daily for 10 days. |
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| Secondary | Pre-morning Dose Concentrations (C0) on Day 2 Through 10 to Assess the Achievement of Steady State of GSK1265744 Following Repeat Administration | Steady state is said to be reached, when the pre-dose concentration slope estimate is close to zero. The data for pre-dose concentration on Day 1 24 hours (Day 2) through Day 10 has been presented. | ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Mean | Standard Deviation | µg/mL | | Day 1 24 hours (Day 2), Pre-dose on Days 3, 4, 7, 8, 9 and 10 | | | | ID | Title | Description |
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| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
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| Secondary | Accumulation Ratios for AUC, Cmax, and Ctau | The accumulation ratio was calculated as the ratio of AUC(0-τ), Cmax, and Ctau on Day 10 to AUC(0-24), Cmax, and C24 on Day 1 for each participant. The ratio of geometric least square means of each parameter on Day 10 to Day 1 was presented along with 90% confidence interval. | PK/ Pharmacodynamic (PD) Summary Population included participants who met the criteria for both ITT Population and PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments. | Posted | | Geometric Least Squares Mean | 90% Confidence Interval | Ratio | | Days 1 and 10 | | | | ID | Title | Description |
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| OG000 | GSK1265744 5 mg | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days. |
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| Secondary | Day 1 AUC(0-24) at Different Doses for the Assessment of Dose Proportionality Using Power Model | Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (AUC[0-24]) using the power model. The mean slope and corresponding 90% confidence interval has been presented. | | Posted | | Mean | 90% Confidence Interval | hr*µg/mL/mg | | Day 1 | | | | ID | Title | Description |
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| OG000 | Pooled GSK1265744 | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451. |
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| Secondary | Day 1 Cmax and C24 at Different Doses for the Assessment of Dose Proportionality Using Power Model | Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (Cmax, and C24) using the power model. The mean slope and corresponding 90% confidence interval has been presented. | | Posted | | Mean | 90% Confidence Interval | μg/mL/mg | | Day 1 | | | | ID | Title | Description |
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| OG000 | Pooled GSK1265744 | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451. |
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| Secondary | Day 10 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality Using Power Model | Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (AUC[0-tau]) using the power model. The mean slope and corresponding 90% confidence interval has been presented. | | Posted | | Mean | 90% Confidence Interval | hr*µg/mL/mg | | Day 10 | | | | ID | Title | Description |
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| OG000 | Pooled GSK1265744 | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451. |
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| Secondary | Day 10 Cmax, C0 and Ctau at Different Doses for the Assessment of Dose Proportionality Using Power Model | Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (Cmax, Ctau and C0) using the power model. The mean slope and corresponding 90% confidence interval has been presented. | | Posted | | Mean | 90% Confidence Interval | µg/mL/mg | | Day 10 | | | | ID | Title | Description |
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| OG000 | Pooled GSK1265744 | Eligible participants received double-blind GSK1265744 5 mg oral tablet once daily for 10 days in the current study ITZ112929 and repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days in study ITZ111451. |
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