Trial Outcomes & Findings for Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults. (NCT NCT00945282)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Results posted on

2018-11-29

Participant Flow

A total of 8 participants with Treatment-Naive, Human Immuno deficiency virus (HIV-1) infection were randomized to the study. The study was conducted from 20 October 2009 to 28 November 2009 at one center in Argentina.

One participant was initially enrolled in the study, however withdrew consent prior to randomization. The study was planned to be conducted in 2 cohorts, however based on safety and antiviral activity of Cohort 1, a second cohort of participants was not needed and the study was stopped.

Participant milestones

Participant milestones
Measure	GSK2248761 30 mg Eligible participants received 3 capsules of GSK2248761 10 milligrams (mg) orally once daily dosed with 360 milliliter (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 Highly active antiretroviral therapy (HAART) for 28 days.	Placebo Eligible participants received 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.
Overall Study STARTED	6	2
Overall Study COMPLETED	6	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2248761 30 mg n=6 Participants 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	Placebo n=2 Participants 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	Total n=8 Participants Total of all reporting groups
Age, Continuous	35.0 years STANDARD_DEVIATION 7.10 • n=5 Participants	28.0 years STANDARD_DEVIATION 5.66 • n=7 Participants	33.3 years STANDARD_DEVIATION 7.15 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 38 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Any AE	4 Participants	1 Participants	—	—	—
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Any SAE	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Lymphocytes, Follow-Up	-110.0 thousand cells per microliter Standard Deviation 375.34	50.0 thousand cells per microliter Standard Deviation 551.54	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Monocytes, Day 4	33.3 thousand cells per microliter Standard Deviation 76.59	120.0 thousand cells per microliter Standard Deviation 155.56	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Monocytes, Follow-Up	10.0 thousand cells per microliter Standard Deviation 143.67	-115.0 thousand cells per microliter Standard Deviation 35.36	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count White blood cell, Day 7	45.0 thousand cells per microliter Standard Deviation 1017.70	-600.0 thousand cells per microliter Standard Deviation 367.70	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Basophils, Day 2	-1.7 thousand cells per microliter Standard Deviation 4.08	-5.0 thousand cells per microliter Standard Deviation 7.07	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Basophils, Day 4	8.3 thousand cells per microliter Standard Deviation 9.83	5.0 thousand cells per microliter Standard Deviation 7.07	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Basophils, Day 7	1.7 thousand cells per microliter Standard Deviation 7.53	-10.0 thousand cells per microliter Standard Deviation 14.14	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Basophils, Day 8	3.3 thousand cells per microliter Standard Deviation 8.16	-10.0 thousand cells per microliter Standard Deviation 14.14	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Basophils, Follow-Up	-3.3 thousand cells per microliter Standard Deviation 10.33	-15.0 thousand cells per microliter Standard Deviation 7.07	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Eosinophils, Day 2	-1.7 thousand cells per microliter Standard Deviation 35.45	-120.0 thousand cells per microliter Standard Deviation 141.42	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Eosinophils, Day 4	-60.0 thousand cells per microliter Standard Deviation 150.33	-20.0 thousand cells per microliter Standard Deviation 0.00	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Eosinophils, Day 7	-38.3 thousand cells per microliter Standard Deviation 106.85	-50.0 thousand cells per microliter Standard Deviation 28.28	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Eosinophils, Day 8	-96.7 thousand cells per microliter Standard Deviation 229.49	-80.0 thousand cells per microliter Standard Deviation 70.71	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Eosinophils, Follow-Up	-63.3 thousand cells per microliter Standard Deviation 153.84	-135.0 thousand cells per microliter Standard Deviation 162.63	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Lymphocytes, Day 2	-120.0 thousand cells per microliter Standard Deviation 272.18	315.0 thousand cells per microliter Standard Deviation 1067.73	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Lymphocytes, Day 4	268.3 thousand cells per microliter Standard Deviation 298.83	260.0 thousand cells per microliter Standard Deviation 296.98	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Lymphocytes, Day 7	126.7 thousand cells per microliter Standard Deviation 415.44	180.0 thousand cells per microliter Standard Deviation 410.12	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Lymphocytes, Day 8	273.3 thousand cells per microliter Standard Deviation 357.64	480.0 thousand cells per microliter Standard Deviation 1060.66	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Monocytes, Day 2	28.3 thousand cells per microliter Standard Deviation 71.11	125.0 thousand cells per microliter Standard Deviation 176.78	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Monocytes, Day 7	-15.0 thousand cells per microliter Standard Deviation 135.17	25.0 thousand cells per microliter Standard Deviation 77.78	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count Monocytes, Day 8	23.3 thousand cells per microliter Standard Deviation 103.67	75.0 thousand cells per microliter Standard Deviation 134.35	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count White blood cell, Day 2	148.3 thousand cells per microliter Standard Deviation 649.78	1295.0 thousand cells per microliter Standard Deviation 2849.64	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count White blood cell, Day 4	758.3 thousand cells per microliter Standard Deviation 896.78	-10.0 thousand cells per microliter Standard Deviation 155.56	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count White blood cell, Day 8	500.0 thousand cells per microliter Standard Deviation 776.79	-240.0 thousand cells per microliter Standard Deviation 1513.21	—	—	—
Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count White blood cell, Follow-Up	-90.0 thousand cells per microliter Standard Deviation 699.29	-110.0 thousand cells per microliter Standard Deviation 2573.87	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Hemoglobin Day 2	-0.40 gram per decilitre Standard Deviation 0.316	-0.50 gram per decilitre Standard Deviation 0.283	—	—	—
Change From Baseline in Hematology Paramaters- Hemoglobin Day 7	-0.25 gram per decilitre Standard Deviation 0.864	-0.45 gram per decilitre Standard Deviation 0.071	—	—	—
Change From Baseline in Hematology Paramaters- Hemoglobin Day 4	-0.28 gram per decilitre Standard Deviation 0.794	0.60 gram per decilitre Standard Deviation 1.273	—	—	—
Change From Baseline in Hematology Paramaters- Hemoglobin Day 8	-0.48 gram per decilitre Standard Deviation 0.585	-0.45 gram per decilitre Standard Deviation 0.354	—	—	—
Change From Baseline in Hematology Paramaters- Hemoglobin Follow-up	-0.93 gram per decilitre Standard Deviation 0.550	-1.00 gram per decilitre Standard Deviation 0.424	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Platelet Count Day 2	-5.7 per cubic millimeter Standard Deviation 24.86	3.0 per cubic millimeter Standard Deviation 9.90	—	—	—
Change From Baseline in Hematology Paramaters- Platelet Count Day 4	5.0 per cubic millimeter Standard Deviation 18.34	-23.5 per cubic millimeter Standard Deviation 37.48	—	—	—
Change From Baseline in Hematology Paramaters- Platelet Count Day 7	18.5 per cubic millimeter Standard Deviation 19.77	2.5 per cubic millimeter Standard Deviation 10.61	—	—	—
Change From Baseline in Hematology Paramaters- Platelet Count Day 8	29.3 per cubic millimeter Standard Deviation 21.04	2.0 per cubic millimeter Standard Deviation 2.83	—	—	—
Change From Baseline in Hematology Paramaters- Platelet Count Follow-up	23.3 per cubic millimeter Standard Deviation 6.50	-1.0 per cubic millimeter Standard Deviation 33.94	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Red Blood Cell Count Day 2	-0.153 million cells per microliter Standard Deviation 0.1129	-0.240 million cells per microliter Standard Deviation 0.0283	—	—	—
Change From Baseline in Hematology Paramaters- Red Blood Cell Count Day 4	-0.112 million cells per microliter Standard Deviation 0.2601	0.200 million cells per microliter Standard Deviation 0.4525	—	—	—
Change From Baseline in Hematology Paramaters- Red Blood Cell Count Day 7	-0.083 million cells per microliter Standard Deviation 0.2947	-0.190 million cells per microliter Standard Deviation 0.0707	—	—	—
Change From Baseline in Hematology Paramaters- Red Blood Cell Count Day 8	-0.170 million cells per microliter Standard Deviation 0.1764	-0.170 million cells per microliter Standard Deviation 0.1556	—	—	—
Change From Baseline in Hematology Paramaters- Red Blood Cell Count Follow-up	-0.343 million cells per microliter Standard Deviation 0.2300	-0.375 million cells per microliter Standard Deviation 0.1344	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Parameters- Total Neutrophil Day 2	243.3 giga cells per liter Standard Deviation 499.83	980.0 giga cells per liter Standard Deviation 1753.62	—	—	—
Change From Baseline in Hematology Parameters- Total Neutrophil Day 4	508.3 giga cells per liter Standard Deviation 692.05	-375.0 giga cells per liter Standard Deviation 21.21	—	—	—
Change From Baseline in Hematology Parameters- Total Neutrophil Day 7	-30.0 giga cells per liter Standard Deviation 750.55	-745.0 giga cells per liter Standard Deviation 49.50	—	—	—
Change From Baseline in Hematology Parameters- Total Neutrophil Day 8	296.7 giga cells per liter Standard Deviation 535.82	-705.0 giga cells per liter Standard Deviation 374.77	—	—	—
Change From Baseline in Hematology Parameters- Total Neutrophil Follow-up	76.7 giga cells per liter Standard Deviation 433.34	105.0 giga cells per liter Standard Deviation 2142.53	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH) Day 2	0.07 picogram Standard Deviation 0.197	0.45 picogram Standard Deviation 0.495	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH) Day 4	0.08 picogram Standard Deviation 0.147	0.05 picogram Standard Deviation 0.071	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH) Day 7	0.03 picogram Standard Deviation 0.320	0.20 picogram Standard Deviation 0.283	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH) Day 8	0.07 picogram Standard Deviation 0.151	0.10 picogram Standard Deviation 0.141	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH) Follow-up	0.13 picogram Standard Deviation 0.367	0.25 picogram Standard Deviation 0.071	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV) Day 7	-0.10 femtoliters Standard Deviation 0.341	-0.40 femtoliters Standard Deviation 0.283	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV) Day 2	0.27 femtoliters Standard Deviation 1.109	-0.10 femtoliters Standard Deviation 0.990	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV) Day 4	0.15 femtoliters Standard Deviation 0.698	-0.20 femtoliters Standard Deviation 0.990	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV) Day 8	0.13 femtoliters Standard Deviation 0.333	-0.15 femtoliters Standard Deviation 0.354	—	—	—
Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV) Follow-up	0.47 femtoliters Standard Deviation 0.753	-0.50 femtoliters Standard Deviation 0.566	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters- Hematocrit Day 2	-1.22 percentage of red blood cells Standard Deviation 1.286	-2.15 percentage of red blood cells Standard Deviation 0.212	—	—	—
Change From Baseline in Hematology Paramaters- Hematocrit Day 4	-0.92 percentage of red blood cells Standard Deviation 2.110	1.70 percentage of red blood cells Standard Deviation 3.536	—	—	—
Change From Baseline in Hematology Paramaters- Hematocrit Day 7	-0.80 percentage of red blood cells Standard Deviation 2.563	-1.85 percentage of red blood cells Standard Deviation 0.495	—	—	—
Change From Baseline in Hematology Paramaters- Hematocrit Day 8	-1.45 percentage of red blood cells Standard Deviation 1.508	-1.55 percentage of red blood cells Standard Deviation 1.202	—	—	—
Change From Baseline in Hematology Paramaters- Hematocrit Follow-up	-2.78 percentage of red blood cells Standard Deviation 1.907	-3.55 percentage of red blood cells Standard Deviation 0.919	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration Day 2	0.02 percentage of red blood cells Standard Deviation 0.445	0.55 percentage of red blood cells Standard Deviation 0.778	—	—	—
Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration Day 4	0.05 percentage of red blood cells Standard Deviation 0.373	0.15 percentage of red blood cells Standard Deviation 0.212	—	—	—
Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration Day 7	0.07 percentage of red blood cells Standard Deviation 0.361	0.40 percentage of red blood cells Standard Deviation 0.283	—	—	—
Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration Day 8	0.02 percentage of red blood cells Standard Deviation 0.214	0.15 percentage of red blood cells Standard Deviation 0.212	—	—	—
Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration Follow-up	-0.03 percentage of red blood cells Standard Deviation 0.301	0.45 percentage of red blood cells Standard Deviation 0.212	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Albumin, Day 2	-0.17 gram per deciliter Standard Deviation 0.207	-0.20 gram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Albumin, Day 4	-0.08 gram per deciliter Standard Deviation 0.248	0.00 gram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Albumin, Day 7	-0.10 gram per deciliter Standard Deviation 0.283	-0.05 gram per deciliter Standard Deviation 0.212	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Albumin, Day 8	-0.05 gram per deciliter Standard Deviation 0.383	-0.10 gram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Albumin, Follow-up	-0.07 gram per deciliter Standard Deviation 0.137	0.05 gram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Total protein, Day 2	-0.45 gram per deciliter Standard Deviation 0.302	-0.55 gram per deciliter Standard Deviation 0.212	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Total protein, Day 4	-0.10 gram per deciliter Standard Deviation 0.385	-0.10 gram per deciliter Standard Deviation 0.283	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Total protein, Day 7	0.10 gram per deciliter Standard Deviation 0.494	0.05 gram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Total protein, Day 8	0.00 gram per deciliter Standard Deviation 0.636	-0.25 gram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein Total protein, Follow-up	-0.30 gram per deciliter Standard Deviation 0.268	-0.20 gram per deciliter Standard Deviation 0.283	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Creatinine, Day 8	-0.060 milligram per deciliter Standard Deviation 0.0569	-0.040 milligram per deciliter Standard Deviation 0.1273	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Cholesterol, Day 8	-8.3 milligram per deciliter Standard Deviation 41.15	-13.5 milligram per deciliter Standard Deviation 0.71	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Total bilirubin, Day 2	-0.12 milligram per deciliter Standard Deviation 0.160	-0.10 milligram per deciliter Standard Deviation 0.141	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Cholesterol, Day 7	-12.0 milligram per deciliter Standard Deviation 35.25	-20.5 milligram per deciliter Standard Deviation 7.78	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Cholesterol, Follow-up	-5.5 milligram per deciliter Standard Deviation 33.44	-0.5 milligram per deciliter Standard Deviation 17.68	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Blood urea nitrogen, Day 2	1.5 milligram per deciliter Standard Deviation 7.20	-1.0 milligram per deciliter Standard Deviation 2.83	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Blood urea nitrogen, Day 4	4.3 milligram per deciliter Standard Deviation 5.32	4.0 milligram per deciliter Standard Deviation 5.66	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Blood urea nitrogen, Day 7	1.0 milligram per deciliter Standard Deviation 7.67	3.5 milligram per deciliter Standard Deviation 2.12	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Blood urea nitrogen, Day 8	2.7 milligram per deciliter Standard Deviation 6.38	5.5 milligram per deciliter Standard Deviation 9.19	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Blood urea nitrogen, Follow-up	-2.2 milligram per deciliter Standard Deviation 7.41	1.0 milligram per deciliter Standard Deviation 15.56	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Triglycerides, Day 2	-17.8 milligram per deciliter Standard Deviation 19.05	5.0 milligram per deciliter Standard Deviation 14.14	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Triglycerides, Day 4	-19.8 milligram per deciliter Standard Deviation 16.47	5.5 milligram per deciliter Standard Deviation 4.95	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Triglycerides, Day 7	5.2 milligram per deciliter Standard Deviation 21.44	20.5 milligram per deciliter Standard Deviation 27.58	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Triglycerides, Day 8	20.8 milligram per deciliter Standard Deviation 63.05	34.0 milligram per deciliter Standard Deviation 21.21	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Triglycerides, Follow-up	-3.0 milligram per deciliter Standard Deviation 12.63	114.0 milligram per deciliter Standard Deviation 8.49	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Glucose, Day 2	1.3 milligram per deciliter Standard Deviation 9.18	6.0 milligram per deciliter Standard Deviation 4.24	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Glucose, Day 4	0.0 milligram per deciliter Standard Deviation 10.92	-0.5 milligram per deciliter Standard Deviation 12.02	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Glucose, Day 7	-1.8 milligram per deciliter Standard Deviation 7.86	-1.0 milligram per deciliter Standard Deviation 1.41	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Total bilirubin, Day 4	-0.08 milligram per deciliter Standard Deviation 0.133	-0.15 milligram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Total bilirubin, Day 7	-0.03 milligram per deciliter Standard Deviation 0.121	-0.05 milligram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Total bilirubin, Day 8	-0.08 milligram per deciliter Standard Deviation 0.075	-0.10 milligram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Total bilirubin, Follow-up	0.08 milligram per deciliter Standard Deviation 0.240	0.00 milligram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Direct bilirubin, Day 2	-0.08 milligram per deciliter Standard Deviation 0.041	0.00 milligram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Direct bilirubin, Day 4	-0.08 milligram per deciliter Standard Deviation 0.041	0.00 milligram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Direct bilirubin, Day 7	-0.05 milligram per deciliter Standard Deviation 0.055	0.05 milligram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Direct bilirubin, Day 8	-0.05 milligram per deciliter Standard Deviation 0.055	0.00 milligram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Direct bilirubin, Follow-up	0.02 milligram per deciliter Standard Deviation 0.075	0.10 milligram per deciliter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Glucose, Day 8	-5.2 milligram per deciliter Standard Deviation 10.72	-5.0 milligram per deciliter Standard Deviation 2.83	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Glucose, Follow-up	3.0 milligram per deciliter Standard Deviation 5.76	10.0 milligram per deciliter Standard Deviation 4.24	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Creatinine, Day 2	-0.048 milligram per deciliter Standard Deviation 0.0770	0.000 milligram per deciliter Standard Deviation 0.0000	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Creatinine, Day 4	0.025 milligram per deciliter Standard Deviation 0.0586	0.025 milligram per deciliter Standard Deviation 0.0071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Creatinine, Day 7	-0.003 milligram per deciliter Standard Deviation 0.0455	0.035 milligram per deciliter Standard Deviation 0.0919	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Creatinine, Follow-up	-0.003 milligram per deciliter Standard Deviation 0.1183	0.060 milligram per deciliter Standard Deviation 0.1273	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Calcium, Day 2	-0.25 milligram per deciliter Standard Deviation 0.176	-0.25 milligram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Calcium, Day 4	-0.13 milligram per deciliter Standard Deviation 0.301	0.05 milligram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Calcium, Day 7	-0.40 milligram per deciliter Standard Deviation 0.322	-0.20 milligram per deciliter Standard Deviation 0.141	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Calcium, Day 8	-0.47 milligram per deciliter Standard Deviation 0.418	-0.45 milligram per deciliter Standard Deviation 0.354	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Calcium, Follow-up	0.08 milligram per deciliter Standard Deviation 0.299	0.05 milligram per deciliter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Cholesterol, Day 2	-11.8 milligram per deciliter Standard Deviation 13.92	-12.0 milligram per deciliter Standard Deviation 8.49	—	—	—
Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin. Cholesterol, Day 4	-15.3 milligram per deciliter Standard Deviation 28.72	-17.5 milligram per deciliter Standard Deviation 10.61	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alanine amino transferase, Day 8	3.7 International units (IU) per liter Standard Deviation 24.40	0.0 International units (IU) per liter Standard Deviation 5.66	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Aspartate amino transferase, Follow-up	-0.2 International units (IU) per liter Standard Deviation 8.40	2.5 International units (IU) per liter Standard Deviation 4.95	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Aspartate amino transferase, Day 2	0.8 International units (IU) per liter Standard Deviation 4.17	1.0 International units (IU) per liter Standard Deviation 1.41	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Aspartate amino transferase, Day 4	-0.2 International units (IU) per liter Standard Deviation 7.31	-4.5 International units (IU) per liter Standard Deviation 3.54	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Aspartate amino transferase, Day 7	-0.3 International units (IU) per liter Standard Deviation 7.69	-3.0 International units (IU) per liter Standard Deviation 8.49	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Aspartate amino transferase, Day 8	1.7 International units (IU) per liter Standard Deviation 9.40	0.0 International units (IU) per liter Standard Deviation 5.66	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alkaline phosphatase, Day 2	-5.8 International units (IU) per liter Standard Deviation 7.14	-16.0 International units (IU) per liter Standard Deviation 0.00	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alkaline phosphatase, Day 4	-1.5 International units (IU) per liter Standard Deviation 10.33	-16.0 International units (IU) per liter Standard Deviation 8.49	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alkaline phosphatase, Day 7	1.8 International units (IU) per liter Standard Deviation 10.83	-7.5 International units (IU) per liter Standard Deviation 4.95	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alkaline phosphatase, Day 8	3.3 International units (IU) per liter Standard Deviation 14.88	-14.5 International units (IU) per liter Standard Deviation 6.36	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alkaline phosphatase, Follow-up	4.2 International units (IU) per liter Standard Deviation 24.96	-9.5 International units (IU) per liter Standard Deviation 0.71	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alanine amino transferase, Day 2	-3.0 International units (IU) per liter Standard Deviation 6.63	0.5 International units (IU) per liter Standard Deviation 6.36	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alanine amino transferase, Day 4	-2.0 International units (IU) per liter Standard Deviation 15.02	-3.5 International units (IU) per liter Standard Deviation 4.95	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alanine amino transferase, Day 7	1.7 International units (IU) per liter Standard Deviation 21.81	-3.5 International units (IU) per liter Standard Deviation 4.95	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase Alanine amino transferase, Follow-up	-7.2 International units (IU) per liter Standard Deviation 21.81	-1.5 International units (IU) per liter Standard Deviation 6.36	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Potassium, Day 2	-0.02 milliequivalents per liter Standard Deviation 0.293	-0.25 milliequivalents per liter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Potassium, Day 4	0.10 milliequivalents per liter Standard Deviation 0.434	0.10 milliequivalents per liter Standard Deviation 0.566	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Carbondioxide, Day 7	2.93 milliequivalents per liter Standard Deviation 1.850	3.60 milliequivalents per liter Standard Deviation 2.121	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Sodium, Day 2	-1.2 milliequivalents per liter Standard Deviation 1.17	-0.5 milliequivalents per liter Standard Deviation 2.12	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Sodium, Day 4	-0.8 milliequivalents per liter Standard Deviation 1.60	1.0 milliequivalents per liter Standard Deviation 1.41	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Sodium, Day 7	-1.5 milliequivalents per liter Standard Deviation 1.64	0.0 milliequivalents per liter Standard Deviation 0.00	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Sodium, Day 8	-1.7 milliequivalents per liter Standard Deviation 1.51	-0.5 milliequivalents per liter Standard Deviation 0.71	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Sodium, Follow-up	2.3 milliequivalents per liter Standard Deviation 1.63	1.0 milliequivalents per liter Standard Deviation 1.41	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Potassium, Day 7	-0.17 milliequivalents per liter Standard Deviation 0.314	-0.10 milliequivalents per liter Standard Deviation 0.000	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Potassium, Day 8	-0.18 milliequivalents per liter Standard Deviation 0.371	-0.00 milliequivalents per liter Standard Deviation 0.141	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Potassium, Follow-up	-0.08 milliequivalents per liter Standard Deviation 0.360	-0.30 milliequivalents per liter Standard Deviation 0.424	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Carbondioxide, Day 2	-0.80 milliequivalents per liter Standard Deviation 2.384	-1.35 milliequivalents per liter Standard Deviation 2.051	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Carbondioxide, Day 4	3.17 milliequivalents per liter Standard Deviation 1.488	2.70 milliequivalents per liter Standard Deviation 4.101	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Carbondioxide, Day 8	0.87 milliequivalents per liter Standard Deviation 2.471	1.65 milliequivalents per liter Standard Deviation 1.768	—	—	—
Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate Carbondioxide, Follow-up	2.03 milliequivalents per liter Standard Deviation 2.187	-0.30 milliequivalents per liter Standard Deviation 1.131	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters- Phosphorus Phosphorus, Day 4	0.07 millimole per liter Standard Deviation 0.799	0.25 millimole per liter Standard Deviation 0.212	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Phosphorus Phosphorus, Day 2	-0.05 millimole per liter Standard Deviation 0.524	-0.80 millimole per liter Standard Deviation 0.707	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Phosphorus Phosphorus, Day 7	-0.17 millimole per liter Standard Deviation 0.628	-0.00 millimole per liter Standard Deviation 0.141	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Phosphorus Phosphorus, Day 8	-0.27 millimole per liter Standard Deviation 0.662	-0.35 millimole per liter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Phosphorus Phosphorus, Follow-up	-0.58 millimole per liter Standard Deviation 0.634	-0.95 millimole per liter Standard Deviation 0.071	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters- Uric Acid Uric acid, Day 2	0.27 Micromole per liter Standard Deviation 0.250	-0.55 Micromole per liter Standard Deviation 0.212	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Uric Acid Uric acid, Day 4	0.17 Micromole per liter Standard Deviation 0.408	-0.70 Micromole per liter Standard Deviation 0.283	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Uric Acid Uric acid, Day 7	-0.15 Micromole per liter Standard Deviation 0.561	-0.80 Micromole per liter Standard Deviation 0.707	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Uric Acid Uric acid, Day 8	-0.60 Micromole per liter Standard Deviation 0.970	-1.05 Micromole per liter Standard Deviation 0.071	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Uric Acid Uric acid, Follow-up	-0.53 Micromole per liter Standard Deviation 0.784	-0.80 Micromole per liter Standard Deviation 0.566	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free Thyroxine free, Follow- up	0.072 Picomole per liter Standard Deviation 0.1332	0.135 Picomole per liter Standard Deviation 0.1485	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free Thyroxine free, Day 2	-0.018 Picomole per liter Standard Deviation 0.0768	0.015 Picomole per liter Standard Deviation 0.0636	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free Thyroxine free, Day 4	0.108 Picomole per liter Standard Deviation 0.1320	0.190 Picomole per liter Standard Deviation 0.0283	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free Thyroxine free, Day 7	0.065 Picomole per liter Standard Deviation 0.1011	0.120 Picomole per liter Standard Deviation 0.1414	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free Thyroxine free, Day 8	0.117 Picomole per liter Standard Deviation 0.1221	0.130 Picomole per liter Standard Deviation 0.0424	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine total, Day 2	-0.60 Nanomoles per liter Standard Deviation 0.648	-0.40 Nanomoles per liter Standard Deviation 0.707	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine total, Day 7	-0.28 Nanomoles per liter Standard Deviation 0.773	0.10 Nanomoles per liter Standard Deviation 0.707	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine total, Day 8	0.00 Nanomoles per liter Standard Deviation 0.874	0.00 Nanomoles per liter Standard Deviation 0.141	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine total, Follow-up	-0.37 Nanomoles per liter Standard Deviation 1.019	0.05 Nanomoles per liter Standard Deviation 1.202	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine binding globulin, Day 2	-0.33 Nanomoles per liter Standard Deviation 5.645	2.00 Nanomoles per liter Standard Deviation 2.828	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine binding globulin, Day 4	-5.00 Nanomoles per liter Standard Deviation 3.688	-6.50 Nanomoles per liter Standard Deviation 3.536	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine binding globulin, Day 7	-0.67 Nanomoles per liter Standard Deviation 7.005	-3.00 Nanomoles per liter Standard Deviation 8.485	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine binding globulin, Day 8	0.17 Nanomoles per liter Standard Deviation 1.169	-1.00 Nanomoles per liter Standard Deviation 2.828	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine binding globulin, Follow-up	-1.83 Nanomoles per liter Standard Deviation 2.787	-1.00 Nanomoles per liter Standard Deviation 8.485	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Total T3, Day 2	-0.013 Nanomoles per liter Standard Deviation 0.1334	0.170 Nanomoles per liter Standard Deviation 0.2404	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Total T3, Day 4	0.068 Nanomoles per liter Standard Deviation 0.2180	0.310 Nanomoles per liter Standard Deviation 0.2687	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Total T3, Day 7	-0.055 Nanomoles per liter Standard Deviation 0.1435	0.225 Nanomoles per liter Standard Deviation 0.2333	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Total T3, Day 8	-0.035 Nanomoles per liter Standard Deviation 0.1252	0.190 Nanomoles per liter Standard Deviation 0.0141	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Total T3, Follow-up	-0.005 Nanomoles per liter Standard Deviation 0.1945	0.375 Nanomoles per liter Standard Deviation 0.1344	—	—	—
Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3. Thyroxine total, Day 4	-0.08 Nanomoles per liter Standard Deviation 0.979	0.50 Nanomoles per liter Standard Deviation 0.283	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 4, Day 7, Day 8 and follow-up

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 4, 4 hour, NCS	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, Pre-dose, NCS	3 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 4 hour, NCS	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 8 hour, NCS	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 4, Pre-dose, NCS	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 4, 8 hour, NCS	3 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 7, Pre-dose, NCS	3 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 7, 4 hour, NCS	3 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 7, 8 hour, NCS	2 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 8, Pre-dose, NCS	3 Participants	0 Participants	—	—	—
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Follow-up, NCS	3 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day -1 or Day 1) and Day 1, 4, 7 , Day 8 and Follow-up (Day 14)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 1, 4 hour	4.3 millimeters of mercury Standard Deviation 6.35	-4.5 millimeters of mercury Standard Deviation 14.85	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 4, Pre-dose	-0.7 millimeters of mercury Standard Deviation 5.92	0.5 millimeters of mercury Standard Deviation 17.68	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 4, 4 hour	3.0 millimeters of mercury Standard Deviation 11.70	12.5 millimeters of mercury Standard Deviation 14.85	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 7, Pre-dose	6.2 millimeters of mercury Standard Deviation 6.94	6.5 millimeters of mercury Standard Deviation 9.19	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 7, 4 hour	9.8 millimeters of mercury Standard Deviation 2.71	14.5 millimeters of mercury Standard Deviation 12.02	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 8	8.5 millimeters of mercury Standard Deviation 7.48	13.5 millimeters of mercury Standard Deviation 19.09	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Follow-up	5.8 millimeters of mercury Standard Deviation 7.33	14.5 millimeters of mercury Standard Deviation 6.36	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 1, 4 hour	8.2 millimeters of mercury Standard Deviation 8.16	1.0 millimeters of mercury Standard Deviation 1.41	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 4, Pre-dose	5.8 millimeters of mercury Standard Deviation 16.58	1.0 millimeters of mercury Standard Deviation 15.56	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 4, 4 hour	9.7 millimeters of mercury Standard Deviation 10.21	3.0 millimeters of mercury Standard Deviation 12.73	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 7, Pre-dose	8.2 millimeters of mercury Standard Deviation 10.96	7.0 millimeters of mercury Standard Deviation 7.07	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 7, 4 hour	6.0 millimeters of mercury Standard Deviation 9.80	8.0 millimeters of mercury Standard Deviation 2.83	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 8	5.2 millimeters of mercury Standard Deviation 10.25	15.0 millimeters of mercury Standard Deviation 9.90	—	—	—
Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Follow-up	4.5 millimeters of mercury Standard Deviation 9.07	8.0 millimeters of mercury Standard Deviation 5.66	—	—	—

PRIMARY outcome

Timeframe: 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)

Population: Safety population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in HR HR , Day 1, 4 hour	-2.5 Beats per minute Standard Deviation 6.50	-3.0 Beats per minute Standard Deviation 4.24	—	—	—
Change From Baseline in HR HR, Day 4, Pre-dose	-2.7 Beats per minute Standard Deviation 6.12	-6.0 Beats per minute Standard Deviation 11.31	—	—	—
Change From Baseline in HR HR, Day 4, 4 hour	-2.2 Beats per minute Standard Deviation 3.92	-6.0 Beats per minute Standard Deviation 21.21	—	—	—
Change From Baseline in HR HR, Day 7, Pre-dose	3.0 Beats per minute Standard Deviation 7.54	-1.0 Beats per minute Standard Deviation 22.63	—	—	—
Change From Baseline in HR HR, Day 7, 4 hour	-0.3 Beats per minute Standard Deviation 4.63	-2.5 Beats per minute Standard Deviation 17.68	—	—	—
Change From Baseline in HR HR, Day 8	3.7 Beats per minute Standard Deviation 7.42	0.0 Beats per minute Standard Deviation 12.73	—	—	—
Change From Baseline in HR HR, Follow-up	-0.3 Beats per minute Standard Deviation 5.99	5.0 Beats per minute Standard Deviation 11.31	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1) to Day 8

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline Through Day 8 in Plasma HIV-1 RNA	-0.967 log 10 copies per milliliter (mL) Standard Deviation 0.3988	-0.036 log 10 copies per milliliter (mL) Standard Deviation 0.2495	—	—	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1) to Day 8

Population: ITT population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline to Nadir in Plasma HIV-1 RNA	-1.019 log10 copies/mL Standard Deviation 0.3687	-0.580 log10 copies/mL Standard Deviation 0.0157	—	—	—

PRIMARY outcome

Timeframe: Day 1 to Day 8

Population: ITT population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
HIV-1 Rate of Decline by Treatment	-0.1243 log10 copies/mL Interval -0.1478 to -0.1008	0.0189 log10 copies/mL Interval -0.0645 to 0.1023	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
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-inf)	2217.73 hours*nanograms (ng)/mL Geometric Coefficient of Variation 45	—	—	—	—
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)	1842.19 hours*nanograms (ng)/mL Geometric Coefficient of Variation 41	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours)

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
GSK2248761 PK Parameters Following Dose Administration on Day 1: Maximum Observed Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) C24	103.40 ng/mL Geometric Coefficient of Variation 61	—	—	—	—
GSK2248761 PK Parameters Following Dose Administration on Day 1: Maximum Observed Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) Cmax	585.43 ng/mL Geometric Coefficient of Variation 39	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 (Pre -dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
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 C0, Day 7	57.47 ng/mL Geometric Coefficient of Variation 83	—	—	—	—
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 Cτ, Day 7	54.27 ng/mL Geometric Coefficient of Variation 75	—	—	—	—
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 Cmin, Day 7	46.37 ng/mL Geometric Coefficient of Variation 83	—	—	—	—
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 Cmax, Day 7	212.93 ng/mL Geometric Coefficient of Variation 41	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
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	4.00 hour Interval 3.0 to 6.0	—	—	—	—
GSK2248761 PK Parameters Following Dose Administration on Day 1: Time to Maximum Observed Concentration (Tmax), Terminal Half-life (t1/2), Absorption Lag Time (Tlag) t1/2	7.99 hour Interval 6.3 to 9.8	—	—	—	—
GSK2248761 PK Parameters Following Dose Administration on Day 1: Time to Maximum Observed Concentration (Tmax), Terminal Half-life (t1/2), Absorption Lag Time (Tlag) tlag	0.49 hour Interval 0.0 to 1.0	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
GSK2248761 PK Parameters Following Dose Administration on Day 1: Apparent Clearance (CL/F)	13.53 liter per hour Geometric Coefficient of Variation 45	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 (Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
GSK2248761 PK Parameters Following Dose Administration on Day 7: AUC(0-τ)	9679.71 hour*ng/mL Geometric Coefficient of Variation 54	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)

Population: PK population.

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

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
GSK2248761 PK Parameters Following Dose Administration on Day 7: Tmax	4.01 hours Interval 3.0 to 6.0	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)

Population: PK population

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

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
GSK2248761 PK Parameters Following Dose Administration on Day 7: t1/2	9.69 hour Geometric Coefficient of Variation 25	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Screening), Day 1 and Day 8

Population: ITT population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8. CD4+ cells, Day 8	87.5 per cubic millimeter Standard Deviation 58.49	102.0 per cubic millimeter Standard Deviation 107.48	—	—	—
Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8. CD8+ cells, Day 1	123.5 per cubic millimeter Standard Deviation 348.90	526.0 per cubic millimeter Standard Deviation 169.71	—	—	—
Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8. CD8+ cells, Day 8	313.3 per cubic millimeter Standard Deviation 218.85	531.5 per cubic millimeter Standard Deviation 539.52	—	—	—
Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8. CD4+ cells, Day 1	1.2 per cubic millimeter Standard Deviation 76.32	76.0 per cubic millimeter Standard Deviation 5.66	—	—	—

SECONDARY outcome

Timeframe: Baseline (Screening), Day 1 and Day 8

Population: ITT population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=2 Participants 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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8 CD4+, Day 1	-3.2 Percent change Standard Deviation 1.78	-2.9 Percent change Standard Deviation 1.27	—	—	—
Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8 CD4+, Day 8	-2.4 Percent change Standard Deviation 1.49	-1.7 Percent change Standard Deviation 0.42	—	—	—
Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8 CD8+, Day 1	-2.8 Percent change Standard Deviation 7.31	2.8 Percent change Standard Deviation 3.82	—	—	—
Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8 CD8+, Day 8	-0.4 Percent change Standard Deviation 2.56	0.4 Percent change Standard Deviation 1.41	—	—	—

SECONDARY outcome

Timeframe: (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) on Day 1 and Day 7

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration Accumulation Ratio Ro	1.576 ratio Interval 1.321 to 1.88	—	—	—	—
Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration Accumulation Ratio R [Cmax]	1.212 ratio Interval 1.009 to 1.456	—	—	—	—
Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration Accumulation Ratio R[Ctau]	1.750 ratio Interval 1.17 to 2.617	—	—	—	—
Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration Time Invariance Ratio Rs	1.309 ratio Interval 1.094 to 1.567	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Screening) and Day 8

Population: ITT population. Data not collected for "Change from baseline reverse transcriptase sequence"

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	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.	IDX899 200 mg The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg The eligible participants in this arm received IDX899 800 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.
Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7 Days 4, 5, 6 and 7	0.052 ng/mL Interval 0.012 to 0.093	—	—	—	—
Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7 Days 5, 6 and 7	-0.019 ng/mL Interval -0.075 to 0.037	—	—	—	—
Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7 Days 6 and 7	-0.056 ng/mL Interval -0.23 to 0.118	—	—	—	—

SECONDARY outcome

Timeframe: (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

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=8 Participants 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.	IDX899 200 mg n=8 Participants The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg n=8 Participants The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg n=8 Participants The eligible participants in this arm received IDX899 800 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.
PK Data of Day 1 AUC(0-inf) and Day 7 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality AUC(0-inf), Day 1	2217.73 hour*ng/mL Geometric Coefficient of Variation 45	9908 hour*ng/mL Geometric Coefficient of Variation 21.07	23817 hour*ng/mL Geometric Coefficient of Variation 46.77	33820 hour*ng/mL Geometric Coefficient of Variation 58.30	37812 hour*ng/mL Geometric Coefficient of Variation 81.37
PK Data of Day 1 AUC(0-inf) and Day 7 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality AUC(0-tau), Day 7	2903.91 hour*ng/mL Geometric Coefficient of Variation 54	11650 hour*ng/mL Geometric Coefficient of Variation 31.02	27209 hour*ng/mL Geometric Coefficient of Variation 47.46	49649 hour*ng/mL Geometric Coefficient of Variation 26.55	53683 hour*ng/mL Geometric Coefficient of Variation 72.34

SECONDARY outcome

Timeframe: (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

Population: PK population.

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.

Outcome measures

Outcome measures
Measure	GSK2248761 30 mg n=6 Participants 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.	Placebo n=8 Participants 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.	IDX899 200 mg n=8 Participants The eligible participants in this arm received IDX899 200 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.	IDX899 400 mg n=8 Participants The eligible participants in this arm received IDX899 400 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.	IDX899 800 mg n=8 Participants The eligible participants in this arm received IDX899 800 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.
PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality Ctau, Day 1	31.02 ng/mL Geometric Coefficient of Variation 61	128.9 ng/mL Geometric Coefficient of Variation 37.36	325.6 ng/mL Geometric Coefficient of Variation 60.93	422.9 ng/mL Geometric Coefficient of Variation 81.23	364.5 ng/mL Geometric Coefficient of Variation 123.77
PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality Cmax, Day 1	175.63 ng/mL Geometric Coefficient of Variation 39	797.8 ng/mL Geometric Coefficient of Variation 32.19	1686.2 ng/mL Geometric Coefficient of Variation 24.67	2625.9 ng/mL Geometric Coefficient of Variation 34.20	3406.4 ng/mL Geometric Coefficient of Variation 31.31
PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality Cmax, Day 7	212.93 ng/mL Geometric Coefficient of Variation 41	960.1 ng/mL Geometric Coefficient of Variation 22.62	2158.9 ng/mL Geometric Coefficient of Variation 35.96	4140.7 ng/mL Geometric Coefficient of Variation 21.54	5394.5 ng/mL Geometric Coefficient of Variation 46.36
PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality Ctau, Day 7	54.27 ng/mL Geometric Coefficient of Variation 75	204.7 ng/mL Geometric Coefficient of Variation 48.36	469.2 ng/mL Geometric Coefficient of Variation 63.17	864.5 ng/mL Geometric Coefficient of Variation 47.44	540.3 ng/mL Geometric Coefficient of Variation 124.71

Adverse Events

GSK2248761 30 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GSK2248761 30 mg n=6 participants at risk 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.	Placebo n=2 participants at risk The eligible participants in this arm received matching placebo once daily for 7-days. On Day 8 participants received either Kaletra or HAART for 28 days
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Up to 38 Days Safety population	0.00% 0/2 • Up to 38 Days Safety population
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to 38 Days Safety population	50.0% 1/2 • Up to 38 Days Safety population
Infections and infestations Nasopharyngitis	16.7% 1/6 • Up to 38 Days Safety population	50.0% 1/2 • Up to 38 Days Safety population
Nervous system disorders Dizziness	16.7% 1/6 • Up to 38 Days Safety population	0.00% 0/2 • Up to 38 Days Safety population
Nervous system disorders Headache	0.00% 0/6 • Up to 38 Days Safety population	50.0% 1/2 • Up to 38 Days Safety population
General disorders Pyrexia	0.00% 0/6 • Up to 38 Days Safety population	50.0% 1/2 • Up to 38 Days Safety population
Psychiatric disorders Anxiety	16.7% 1/6 • Up to 38 Days Safety population	0.00% 0/2 • Up to 38 Days Safety population
Vascular disorders Hypertension	16.7% 1/6 • Up to 38 Days Safety population	0.00% 0/2 • Up to 38 Days Safety population

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER