| Primary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical investigation 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 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, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury. | Safety population was defined as all participants who were randomized into the study with documented evidence of receipt of at least one dose of randomized treatment. | Posted | | Count of Participants | | Participants | | Up to 38 days | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. |
| | | Title | Denominators | Categories |
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| Any AE | | | | Any SAE | | |
| |
| Primary | Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count | The data for hematology parameters for Basophils, eosinophils, lymphocytes, monocytes, and white blood cell count from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | thousand cells per microliter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 |
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| Primary | Change From Baseline in Hematology Paramaters- Hemoglobin | The data for hematology parameter hemoglobin from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | gram per decilitre | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Paramaters- Platelet Count | The data for hematology parameter platelet count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | per cubic millimeter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Paramaters- Red Blood Cell Count | The data for hematology parameter red blood cell count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | million cells per microliter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Parameters- Total Neutrophil | The data for hematology parameter total neutrophil count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | giga cells per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH) | The data for hematology parameter MCH, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | picogram | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV) | The change from baseline data for hematology parameter MCV, was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | femtoliters | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Paramaters- Hematocrit | The data for hematology parameter Hematocrit, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | percentage of red blood cells | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration | The data for hematology parameter Mean Corpuscle Hemoglobin concentration, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | percentage of red blood cells | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein | The data for clinical chemistry parameters Albumin and total protein, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | gram per deciliter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. |
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| Primary | Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. | The data for clinical chemistry parameters- Blood urea nitrogen, triglycerides, glucose, creatinine, calcium, cholesterol, total bilirubin, and direct bilirubin. The change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | milligram per deciliter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase | The data for clinical chemistry paramaters- alkaline phosphatase, alanine amino transferase, aspartate amino transferase, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | International units (IU) per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate | The data for clinical chemistry parameters- sodium, potassium and carbon dioxide or bicarbonate, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | milliequivalents per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters- Phosphorus | The data for clinical chemistry paramaters- phosphorous, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | millimole per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters- Uric Acid | The data for clinical chemistry parameters Uric acid, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | Micromole per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free | The data for clinical chemistry parameters Thyroxine, free the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | Picomole per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. | The data for clinical chemistry parameters Thyroxine total, thyroxine binding globulin, Total T3 the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | Nanomoles per liter | | Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Triplicate 12-lead ECGs were collected at different timepoints, after participants were supine for 5 minutes, during the study using an ECG machine that automatically calculated the heart rate (HR) and measures PR, QRS, QT, and QTc intervals. The three consecutive determinations were collected 5 plus or minus 2 minutes apart and all three tracings were recorded. The participants with abnormal values categorized as abnormal clinically significant (CS) and not clinically significant (NCS) were reported. | | Posted | | Count of Participants | | Participants | | Day 1, Day 4, Day 7, Day 8 and follow-up | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital sign measurements for SBP and DBP after sitting for 5 minutes were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | millimeters of mercury | | Baseline (pre-dose at Day -1 or Day 1) and Day 1, 4, 7 , Day 8 and Follow-up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in HR | Vital sign measurements for HR after sitting for 5 minutes were measured. The average mean values were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose [Screening, Day -1 or Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (pre-dose at Day -1 or Day 1) and Day 1 (4-hour), Day 4 (Pre-dose and 4 hour), Day 7 (pre-dose and 4-hour), Day 8 and follow up (Day 14) | | | | ID | Title | Description |
|---|
| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline Through Day 8 in Plasma HIV-1 RNA | The quantitative analysis of plasma was done to evaluate the amount of HIV-1 RNA at Day 1,2,3,4,5,6,7, 8 and End of treatment visit. The quantification was done using a Polymerase chain reactor (PCR). The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | The Intent-to-treat Exposed (ITT) Population was defined as all participants who met the study criteria and were randomized into the study with documented evidence of having received at least 1 dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement and have Day 1 HIV-RNA>1500 copies/mL. | Posted | | Mean | Standard Deviation | log 10 copies per milliliter (mL) | | Baseline (pre-dose Day 1) to Day 8 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline to Nadir in Plasma HIV-1 RNA | The quantification of plasma HIV-1 RNA, was conducted for the change from baseline to on treatment nadir (maximum change) before starting HAART or Kaletra monotherapy on Day 8. The quantification was done using a PCR. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise. | | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline (pre-dose Day 1) to Day 8 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | HIV-1 Rate of Decline by Treatment | The rate of decrease in the viral load of HIV-1 virus in response to individual treatment was measured. The viral load data was assumed to have a log normal prior distribution and followed linear decline with non-informative conjugate prior densities. The rate of decline (slope of the day) for each treatment was measured using a PCR from Day 1 to Day 8. The slope has been reported as mean. | | Posted | | Mean | 90% Confidence Interval | log10 copies/mL | | Day 1 to Day 8 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Plasma Concentration Time Curve 0 to Infinite (AUC[0-∞]) and Area Under the Plasma Concentration Time Curve (AUC [0-24]) | AUC (0-24), measured the plasma concentration of GSK2248761 against time, from time zero (pre-dose) to 24 hrs post-dose AUC (0-24) and from time zero to extrapolated infinite time AUC (0-∞). Serial blood samples were collected on Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis. | The PK Concentration Population included all participants who received GSK22648761 and underwent plasma PK sampling during the study. Participants for whom a plasma PK sample was obtained and assayed were included in the listing of plasma GSK2248761 concentration-time data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms (ng)/mL | | Day 1 (Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 1: Maximum Observed Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) | Cmax represents the maximum concentration of GSK2248761 in the plasma. C24 is defined as the measure of plasma drug concentration of GSK2248761, 24 hours post dose, determined on Day 1. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.Data for dose normalized Cmax and C24 was reported. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 7: Predose Concentration (C0), Concentration at End of Dosing Interval (Cτ), Minimum Observed Concentration During One Dosing Interval (Cmin) and Cmax | The C0 was defined as the concentration of drug in plasma, before dose administration on Day 7. Cτ, was defined as the concentration of drug in the plasma at the end of dosing interval. The Cmin was defined as the minimum concentration of the drug in plasma during one dosing interval on Day 7. Cmax represents the maximum concentration of GSK2248761 in the plasma on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 7 (Pre -dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 1: Time to Maximum Observed Concentration (Tmax), Terminal Half-life (t1/2), Absorption Lag Time (Tlag) | Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 1. The t1/2 was defined as the time measured for plasma concentration to decrease by one half. The tlag was defined as the time taken for the drug GSK2248761, to appear in the systemic circulation following administration. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis. | | Posted | | Median | Full Range | hour | | Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 1: Apparent Clearance (CL/F) | The Clearance factor was defined as the volume of plasma cleared of the drug GSK2248761, per unit time. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour | | Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 7: AUC(0-τ) | AUC(0-τ) is the AUC to the end of dosing period. For Day 7, it is the AUC measured at the end of the dosing period at Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*ng/mL | | Day 7 (Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 7: Tmax | Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis | | Posted | | Median | Full Range | hours | | Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | GSK2248761 PK Parameters Following Dose Administration on Day 7: t1/2 | The t1/2 was defined as the time measured for plasma concentration to decrease by one half. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour | | Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose) | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Primary | Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8. | Whole venous blood samples were obtained from each participant for the analysis of lymphocyte subsets by flow cytometry (total lymphocyte counts, percentage, CD4+ cell counts, and CD8+ cell counts) at Screening, Day 1 and Day 8. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values (Day 1 and Day 8). Baseline was defined as Screening. | | Posted | | Mean | Standard Deviation | per cubic millimeter | | Baseline (Screening), Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Secondary | Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8 | Data for CD4+ and CD8+ cells was collected at Screening, Day 1 and Day 8. The percent change from baseline was reported at Day 1 and Day 8. Baseline was defined as Screening. The percent change from baseline was calculated as post-randomization value minus the baseline value. | | Posted | | Mean | Standard Deviation | Percent change | | Baseline (Screening), Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Secondary | Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration | The accumulation ratio is based on the parameters, Cmax, AUC(0-tau), AUC(0-24), C(tau), C24, AND AUC(0-inf). The accumulation ratio Ro was the ratio of AUC(0-tau) on Day 7 to that of AUC(0-24) on Day 1; the accumulation ratio R (Cmax) was the ratio of Cmax on Day 7 to that of Cmax on Day 1; the accumulation ratio R(Ctau) was the ratio of Ctau on Day 7 to the ratio of C24 on Day 1 and the Time Invariance Ratio Rs was defined as the ratio of AUC(0-tau) on Day 7 to that of AUC(0-inf) on Day 1. The ratio has been reported as number. | | Posted | | Number | 90% Confidence Interval | ratio | | (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) on Day 1 and Day 7 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days. |
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| Secondary | Change From Baseline in Reverse Transcriptase Sequences of HIV-1 at Day 8 | None of the participants had non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations at codons 90, 98, 100, 101, 103, 106, 108, 138, 179, 181, 188, 190, 225, or 230 at either Day 1 or Day 8. No mutation selected by GSK2248761 in vitro was observed for any participant at either Day 1 or Day 8. This data for "Change from baseline in reverse transcriptase sequences of HIV-1 at Day 8" not collected. | ITT population. Data not collected for "Change from baseline reverse transcriptase sequence" | Posted | | | | | | Baseline (Screening) and Day 8 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days | | OG001 | Placebo | Eligible participants matching placebo capsules to GSK2248761 10 mg capsules orally once daily dosed with 360 mL water after a standard breakfast upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Secondary | Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7 | The pre-dose GSK2248761 steady state concentration, following repeated dose administration from Day 2 through Day 7 was assessed. Serial dose sampling was done on each day of Day 2, 3, 4, 5 and Day 6 and for Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose), before the administration of the study drug daily. | | Posted | | Mean | 90% Confidence Interval | ng/mL | | Day 7 (Pre - dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) and Days 2, 3, 4. 5 and 6: pre-dose only | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | Eligible participants received 3 capsules of GSK2248761 10 mg orally once daily dosed with 360 mL water after a standard breakfast, upto 7-days. Participants were to have fasted 4 hours after dosing. Unless otherwise instructed participants were not to recline (remained upright) for the first 4 hours following oral administration. On Day 8 participants received either Kaletra or HAART for 28 days |
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| Secondary | PK Data of Day 1 AUC(0-inf) and Day 7 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality | Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. The dose proportionality effects of IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg, following repeat dose administration on Day 7 for the PK parameter AUC(0-tau) has been reported. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*ng/mL | | (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | The eligible participants in this arm received GSK2248761 as 30 mg once daily for up to 7-days daily. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 | IDX899 100 mg | The eligible participants in this arm received IDX899 100 mg, once daily orally for upto 7-days daily. The dose was accompanied with 360 mL of water. On Day 8 participants received either Kaletra or HAART for 28 days. Data was taken from the Idenix NV-05A-002 study. |
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| Secondary | PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality | Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. Data for Ctau on Day 1 is presented for concentration at 24 hours post-dose on Day 1. | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7 | | | | ID | Title | Description |
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| OG000 | GSK2248761 30 mg | The eligible participants in this arm received GSK2248761 as 30 mg once daily for up to 7-days daily. On Day 8 participants received either Kaletra or HAART for 28 days. | | OG001 | IDX899 100 mg | The eligible participants in this arm received IDX899 100 mg, once daily orally for upto 7-days daily. The dose was accompanied with 360 mL of water. On Day 8 participants received either Kaletra or HAART for 28 days. Data was taken from the Idenix NV-05A-002 study. | | OG002 |
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