Trial Outcomes & Findings for Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults (NCT NCT00708110)

Last Updated: 2013-12-05

Results Overview

Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Baseline (Day 1) and Day 11

Results posted on

2013-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 10 mg QD Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
Overall Study STARTED	7	9	9	10
Overall Study COMPLETED	7	9	9	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Total n=35 Participants Total of all reporting groups
Age Continuous	39.6 Years STANDARD_DEVIATION 10.64 • n=5 Participants	41.1 Years STANDARD_DEVIATION 10.47 • n=7 Participants	39.9 Years STANDARD_DEVIATION 4.14 • n=5 Participants	33.7 Years STANDARD_DEVIATION 10.45 • n=4 Participants	38.4 Years STANDARD_DEVIATION 9.38 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	2 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	7 participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	5 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	28 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 11

Population: Intent to Treat Exposed (ITT\[E\]) Population: all participants who met study criteria and were randomized into the study with documented evidence of having received at least one dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11	-2.03 Log10 copies/milliliter (log10 copies/mL Standard Deviation 0.49	-2.46 Log10 copies/milliliter (log10 copies/mL Standard Deviation 0.35	0.05 Log10 copies/milliliter (log10 copies/mL Standard Deviation 0.26	-1.51 Log10 copies/milliliter (log10 copies/mL Standard Deviation 0.58

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Summary (PKS) Population: participants (par.) with an evaluable profile of GSK1349572 on Day 10. Par. were excluded if they vomited within 2 hours of dosing on Day 10, missed more than one dose 2 days prior to Day 10, and took prohibited concomitant medication during the treatment period. No par. were analyzed in the placebo group.

AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to24 hours. Blood samples for pharmacokinetic (PK) analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1 AUC(0-inf)	10.1 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 26	40.5 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 33	—	2.63 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 39
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1 AUC(0-24)	7.41 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 27	30.34 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 33	—	2.05 Microgramshour per milliliter (µghr/mL Geometric Coefficient of Variation 33

PRIMARY outcome

Timeframe: Day 1

Population: PKS Population. No participants were analyzed in the placebo group.

Cmax is defined as the maximum observed plasma concentration, and C24 is defined as the concentration at 24 hours post dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, Cmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1 Cmax	0.57 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 28	2.46 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 32	—	0.18 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 35
Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1 C24	0.15 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 30	0.59 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 31	—	0.03 Micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 49

PRIMARY outcome

Timeframe: Day 1

Population: PKS Population. No participants were analyzed for the placebo group.

tmax is defined as the time to the maximum obsevered plasma concentration. Absorption lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. tlag was estimated based on PK sampling times of 0 (pre-dose), 0.5, 1, 1.5, 2 3, 4, 6, 8, 12, and 24 hours post-dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1 tmax	2.00 Hours Interval 1.02 to 6.0	2.09 Hours Interval 1.0 to 3.97	—	1.50 Hours Interval 0.5 to 3.0
Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1 tlag	0 Hours Interval 0.0 to 0.0	0 Hours Interval 0.0 to 0.0	—	0 Hours Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Day 1

Population: PKS Population. No participants were analyzed for the placebo group.

The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1	11.8 Hours Geometric Coefficient of Variation 22	11.2 Hours Geometric Coefficient of Variation 29	—	10.7 Hours Geometric Coefficient of Variation 30

PRIMARY outcome

Timeframe: Day 1

Population: PKS Population. No participants were analyzed for the placebo group.

The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1	0.99 Liters per hour (L/hr) Geometric Coefficient of Variation 26	1.23 Liters per hour (L/hr) Geometric Coefficient of Variation 33	—	0.76 Liters per hour (L/hr) Geometric Coefficient of Variation 39

PRIMARY outcome

Timeframe: Day 10

Population: PKS Population. No participants were analyzed for the placebo group.

AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-tau) is defined as the area under the concentration-time curve over the dosing interval. Blood samples for PK analysis of GSK1349572 were obtained on Day 10at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10	10.13 µg*hr/mL Geometric Coefficient of Variation 20	43.39 µg*hr/mL Geometric Coefficient of Variation 20	—	2.56 µg*hr/mL Geometric Coefficient of Variation 29

PRIMARY outcome

Timeframe: Day 10

Population: PKS Population. No participants were analyzed for the placebo group.

C0 is defined as the pre-dose concentration. Ctau is defined as the concentration at the end of the dosing interval. Cmin is defined as the minimum observed concentration during one dosing interval. Cmax is defined as the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration C0	0.20 µg/mL Geometric Coefficient of Variation 28	0.82 µg/mL Geometric Coefficient of Variation 44	—	0.04 µg/mL Geometric Coefficient of Variation 51
Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration Ctau	0.19 µg/mL Geometric Coefficient of Variation 25	0.83 µg/mL Geometric Coefficient of Variation 26	—	0.04 µg/mL Geometric Coefficient of Variation 50
Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration Cmin	0.19 µg/mL Geometric Coefficient of Variation 26	0.81 µg/mL Geometric Coefficient of Variation 43	—	0.04 µg/mL Geometric Coefficient of Variation 51
Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration Cmax	0.80 µg/mL Geometric Coefficient of Variation 23	3.34 µg/mL Geometric Coefficient of Variation 16	—	0.22 µg/mL Geometric Coefficient of Variation 25

PRIMARY outcome

Timeframe: Day 10

Population: PKS Population. No participants were analyzed for the placebo group.

tmax is defined as the time to the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10	1.48 Hours Interval 0.5 to 3.0	2.00 Hours Interval 0.97 to 4.0	—	1.00 Hours Interval 0.42 to 3.0

PRIMARY outcome

Timeframe: Day 10

Population: PKS Population. No participants were analysed for the placebo group.

The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10	11.64 Hours Geometric Coefficient of Variation 21	11.95 Hours Geometric Coefficient of Variation 22	—	11.13 Hours Geometric Coefficient of Variation 24

PRIMARY outcome

Timeframe: Day 10

Population: PKS Population. No participants were analyzed for the placebo group.

The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=7 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10	0.99 L/hr Geometric Coefficient of Variation 20	1.15 L/hr Geometric Coefficient of Variation 20	—	0.78 L/hr Geometric Coefficient of Variation 29

PRIMARY outcome

Timeframe: From Baseline (Day 1) until Follow-up (average of 3 study weeks)

Population: Safety Population: all participants who were randomized into the study with documented evidence of having received at least one dose of randomized treatment

An AE is defined as 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, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE) Any Non-serious AE	7 participants	7 participants	5 participants	4 participants
Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE) Any SAE	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From Baseline (Day 1) until Follow-up (average of 3 study weeks)

Population: Safety Population. Only those participants who received a concomitant medication were analyzed.

Concomitant medications received during the study period are presented by generic term. Only those concomitant medications that were received by at least two participants are presented. "Multiple ingredient" is the term used in the statistical package for items that contain more than one active ingredient.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=5 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=4 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Multiple ingredients (combination product)	4 participants	5 participants	3 participants	2 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Ibuprofen	3 participants	2 participants	0 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Bupropion hydrochloride	1 participants	1 participants	0 participants	1 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Escitalopram oxalate	1 participants	0 participants	2 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Acetylsalicylic acid	0 participants	1 participants	0 participants	1 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Ascorbic acid	0 participants	0 participants	1 participants	1 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Cyanocobalamin	1 participants	0 participants	0 participants	1 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Fish oil	1 participants	1 participants	0 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Loratadine	2 participants	0 participants	0 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Ranitidine hydrochloride	1 participants	1 participants	0 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Trazodone	1 participants	1 participants	0 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Valacyclovir hydrochloride	0 participants	1 participants	1 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Vitamin B substances (not otherwise specified)	0 participants	1 participants	1 participants	0 participants
Number of Participants Who Received the Indicated Concomitant Medications During the Study Period Zolpidem tartrate	1 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline and Days 1, 4, 7, and 10

Population: Safety Population

Blood pressure measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Change in the mean blood pressure from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose \[hrs\]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 SBP, Day 4, 1 hr pre-dose	1.72 millimeters of mercury (mmHg) Standard Deviation 11.880	-7.60 millimeters of mercury (mmHg) Standard Deviation 10.325	-1.64 millimeters of mercury (mmHg) Standard Deviation 10.221	1.78 millimeters of mercury (mmHg) Standard Deviation 4.874
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 SBP, Day 1, 2 hrs post dose	-2.17 millimeters of mercury (mmHg) Standard Deviation 5.551	3.10 millimeters of mercury (mmHg) Standard Deviation 12.927	-5.93 millimeters of mercury (mmHg) Standard Deviation 6.051	-1.11 millimeters of mercury (mmHg) Standard Deviation 6.348
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 SBP, Day 7, 1 hr pre-dose	2.28 millimeters of mercury (mmHg) Standard Deviation 8.544	-2.90 millimeters of mercury (mmHg) Standard Deviation 9.351	0.08 millimeters of mercury (mmHg) Standard Deviation 12.188	-0.56 millimeters of mercury (mmHg) Standard Deviation 10.227
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 SBP, Day 10, 1 hr pre-dose	4.94 millimeters of mercury (mmHg) Standard Deviation 6.640	-6.40 millimeters of mercury (mmHg) Standard Deviation 11.520	-3.21 millimeters of mercury (mmHg) Standard Deviation 11.419	2.89 millimeters of mercury (mmHg) Standard Deviation 10.836
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 SBP, Day 10, 2 hrs post dose	3.50 millimeters of mercury (mmHg) Standard Deviation 10.974	-6.40 millimeters of mercury (mmHg) Standard Deviation 10.453	-2.07 millimeters of mercury (mmHg) Standard Deviation 11.193	2.67 millimeters of mercury (mmHg) Standard Deviation 9.311
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 DBP, Day 1, 2 hrs post dose	2.33 millimeters of mercury (mmHg) Standard Deviation 4.183	-2.70 millimeters of mercury (mmHg) Standard Deviation 8.210	0.64 millimeters of mercury (mmHg) Standard Deviation 5.321	1.39 millimeters of mercury (mmHg) Standard Deviation 4.060
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 DBP, Day 4, 1 hr pre-dose	-0.67 millimeters of mercury (mmHg) Standard Deviation 7.036	-3.20 millimeters of mercury (mmHg) Standard Deviation 4.423	0.50 millimeters of mercury (mmHg) Standard Deviation 6.658	1.72 millimeters of mercury (mmHg) Standard Deviation 7.480
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 DBP, Day 7, 1 hr pre-dose	1.33 millimeters of mercury (mmHg) Standard Deviation 6.708	-2.40 millimeters of mercury (mmHg) Standard Deviation 6.599	-0.58 millimeters of mercury (mmHg) Standard Deviation 7.262	1.61 millimeters of mercury (mmHg) Standard Deviation 8.543
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 DBP, Day 10, 1 hr pre-dose	4.11 millimeters of mercury (mmHg) Standard Deviation 6.314	-7.00 millimeters of mercury (mmHg) Standard Deviation 7.619	0.07 millimeters of mercury (mmHg) Standard Deviation 8.696	0.17 millimeters of mercury (mmHg) Standard Deviation 4.690
Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10 DBP, Day 10, 2 hrs post dose	6.00 millimeters of mercury (mmHg) Standard Deviation 9.131	-4.90 millimeters of mercury (mmHg) Standard Deviation 8.140	-0.79 millimeters of mercury (mmHg) Standard Deviation 10.912	0.83 millimeters of mercury (mmHg) Standard Deviation 8.775

PRIMARY outcome

Timeframe: Baseline and Days 1, 4, 7, and 10

Population: Safety Population

Heart rate is the measure of heart beats per minute (bpm). Change in the mean heart rate from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose \[hrs\]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10 Day 1, 2 hrs post dose	-2.83 beats per minute Standard Deviation 5.734	-6.85 beats per minute Standard Deviation 5.907	-3.71 beats per minute Standard Deviation 6.861	-7.67 beats per minute Standard Deviation 6.461
Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10 Day 4, 1 hr pre-dose	6.50 beats per minute Standard Deviation 9.434	2.95 beats per minute Standard Deviation 12.513	3.43 beats per minute Standard Deviation 11.133	-3.22 beats per minute Standard Deviation 6.610
Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10 Day 7, 1 hr pre-dose	3.72 beats per minute Standard Deviation 8.511	-2.85 beats per minute Standard Deviation 9.196	2.86 beats per minute Standard Deviation 10.984	0.67 beats per minute Standard Deviation 8.047
Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10 Day 10, 1 hr pre-dose	3.83 beats per minute Standard Deviation 8.162	-0.95 beats per minute Standard Deviation 8.268	3.29 beats per minute Standard Deviation 16.230	0.56 beats per minute Standard Deviation 9.547
Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10 Day 10, 2 hrs post dose	-3.72 beats per minute Standard Deviation 8.635	-7.05 beats per minute Standard Deviation 7.890	-1.57 beats per minute Standard Deviation 14.351	0.44 beats per minute Standard Deviation 13.907

PRIMARY outcome

Timeframe: Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21)

Population: Safety Population. Only those participants who were available at the indicated time points were analyzed.

A 12-lead electrocardiogram (ECG) was performed by qualified personnel at the site after the participant had rested for at least 5 minutes in a semi-recumbent or supine position. If a QTc measurement of \>=500 milliseconds (msec) was noted on a scheduled or unscheduled ECG, two additional ECGs were to be obtained within 5 minutes to confirm the abnormality. The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) ECG findings are presented here. The site determined if an ECG finding is significant or not. ECGs were obtained at Screening, Day 1 (pre-dose \[twice\] and then 1.0, 1.5, and 2.0 hours \[hrs\] post dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10 (pre-dose and then 1.0, 1.5, and 2.0 hrs post dose), Day 11 (prior to the 24 hr PK sample \[pre lab\]), and Follow-up.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Screening, Normal, n=7, 9, 9, 10	8 participants	9 participants	5 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Screening, NCS, n=7, 9, 9, 10	1 participants	1 participants	2 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Screening, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, pre-dose 1, Normal, n=7, 9, 9, 10	9 participants	8 participants	5 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, pre-dose 1, NCS, n=7, 9, 9, 10	0 participants	2 participants	2 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, pre-dose 1, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, pre-dose 2, Normal, n=7, 9, 9, 10	9 participants	8 participants	5 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, pre-dose 2, NCS, n=7, 9, 9, 10	0 participants	2 participants	2 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, pre-dose 2, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 1 hr post dose, Normal, n=7, 9, 9, 10	9 participants	8 participants	6 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 1 hr post dose, NCS, n=7, 9, 9, 10	0 participants	2 participants	1 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 1 hr post dose, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 1.5 hrs post dose, Normal, n=7, 9, 9, 10	8 participants	7 participants	5 participants	6 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 1.5 hrs post dose, NCS, n=7, 9, 9, 10	1 participants	3 participants	2 participants	3 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 1.5 hrs post dose, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 2 hrs post dose, Normal, n=7, 9, 9, 10	7 participants	8 participants	5 participants	6 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 2 hrs post dose, NCS, n=7, 9, 9, 10	2 participants	2 participants	2 participants	3 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1, 2 hrs post dose, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 4, pre-dose, Normal, n=7, 9, 9, 10	8 participants	9 participants	3 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 4, pre-dose, CS, n=7, 9, 9, 10	2 participants	1 participants	4 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 4, pre-dose, NCS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 7, pre-dose, Normal	9 participants	9 participants	4 participants	9 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 7, pre-dose, CS, n=7, 9, 9, 10	0 participants	1 participants	3 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 7, pre-dose, NCS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, pre-dose 1, Normal, n=7, 9, 9, 10	8 participants	8 participants	4 participants	8 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, pre-dose 1, NCS, n=7, 9, 9, 10	1 participants	2 participants	3 participants	1 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, pre-dose 1, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 1 hr post dose, Normal, n=7, 9, 9, 10	8 participants	8 participants	4 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 1 hr post dose, NCS, n=7, 9, 9, 10	1 participants	2 participants	3 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 1 hr post dose, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 1.5 hrs post dose, Normal, n=7, 9, 9, 9	8 participants	8 participants	2 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 1.5 hrs post dose, NCS, n=7, 9, 9, 9	1 participants	1 participants	5 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 1.5 hrs post dose, CS, n=7, 9, 9, 9	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 2 hrs post dose, Normal, n=7, 9, 9, 10	8 participants	7 participants	3 participants	7 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 2 hrs post dose, NCS, n=7, 9, 9, 10	1 participants	3 participants	4 participants	2 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 10, 2 hrs post dose, CS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 11, pre lab, Normal, n=7, 9, 9, 10	9 participants	10 participants	3 participants	6 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 11, pre lab, CS, n=7, 9, 9, 10	0 participants	0 participants	4 participants	3 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 11, pre lab, NCS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Follow-up, Normal, n=7, 9, 9, 10	9 participants	9 participants	2 participants	8 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Follow-up, CS, n=7, 9, 9, 10	0 participants	1 participants	5 participants	1 participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Follow-up, NCS, n=7, 9, 9, 10	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21)

Population: Safety Population

Clinical laboratory toxicities were graded according to the National Institutes of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented only for Grade 3 and Grade 4 laboratory abnormalities. Clinical laboratory abnormalities included: increased glucose, lipase, decreased platelets, and triglycerides.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Increased glucose, Screening, n=7, 9, 9, 10	0 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Increased Glucose, Day 7, n=7, 9, 9, 9	0 participants	0 participants	0 participants	1 participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Lipase, Day 10, n=7, 9, 9, 9	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Decreased platelets, Day 1, n=6, 9, 9, 9	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Decreased platelets, Day 3, n=6, 9, 9, 10	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Decreased platelets, follow-up, n=7, 9, 9, 10	1 participants	0 participants	0 participants	0 participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities Triglycerides, Day 7, n=7, 9, 9, 9	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Day 11

Population: ITT(E) Population

Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11	-2.09 Log10 copies/mL Standard Deviation 0.49	-2.61 Log10 copies/mL Standard Deviation 0.35	-0.31 Log10 copies/mL Standard Deviation 0.50	-1.58 Log10 copies/mL Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline and Day 11

Population: ITT(E) Population

Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11	-1.99 Log10 copies/mL Interval -2.71 to -1.43	-2.55 Log10 copies/mL Interval -3.28 to -2.16	-0.12 Log10 copies/mL Interval -1.39 to 0.0	-1.65 Log10 copies/mL Interval -2.34 to -0.86

SECONDARY outcome

Timeframe: Day 1 to Day 11

Population: ITT(E) Population

The rate of decline of plasma HIV-1 RNA levels from Day 1 to Day 11 was measured.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Plasma HIV-1 RNA Rate of Decline Over 10 Days	-0.20 Log10 copies/mL/day Interval -0.21 to -0.18	-0.25 Log10 copies/mL/day Interval -0.27 to -0.24	0 Log10 copies/mL/day Interval -0.01 to 0.01	-0.14 Log10 copies/mL/day Interval -0.16 to -0.12

SECONDARY outcome

Timeframe: Day 11

Population: ITT(E) Population

The number of participants who achieved plasma HIV-1 RNA levels \<400 copies/mL and \<50 copies/mL through Day 11 was measured.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL <400 copies/mL	4 participants	9 participants	0 participants	1 participants
Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL <50 copies/mL	0 participants	4 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and Follow-up period (Days 11 to 21)

Population: ITT(E) Population

Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)	-0.150 Log10 copies/mL Interval -0.61 to 0.34	-0.887 Log10 copies/mL Interval -1.96 to 0.26	-0.069 Log10 copies/mL Interval -1.39 to 0.22	-0.169 Log10 copies/mL Interval -0.92 to 0.54

SECONDARY outcome

Timeframe: Baseline and Follow-up period (Days 11 to 21)

Population: ITT(E) Population

Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)	-0.154 Log10 copies/mL Standard Deviation 0.3126	-0.899 Log10 copies/mL Standard Deviation 0.6997	-0.188 Log10 copies/mL Standard Deviation 0.5443	-0.149 Log10 copies/mL Standard Deviation 0.3931

SECONDARY outcome

Timeframe: Baseline and Day 11

Population: Per-Protocol Population: all participants included in the ITT(E) Population, excluding those who had at least one major protocol deviation

Median change from Baseline in CD4+ cell count was calculated as the Day 11 value minus the Baseline value.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11	106.0 Cells per cubic millimeter (cells/mm^3) Interval -39.0 to 142.0	64.0 Cells per cubic millimeter (cells/mm^3) Interval -155.0 to 523.0	-28.5 Cells per cubic millimeter (cells/mm^3) Interval -247.0 to 50.0	15.0 Cells per cubic millimeter (cells/mm^3) Interval -286.0 to 222.0

SECONDARY outcome

Timeframe: Baseline and Day 11

Population: ITT(E) Population

The number of participants with the emergence (from Baseline) of drug resistance mutations at Day 11 was measured.

Outcome measures

Outcome measures
Measure	GSK1349572 10 mg QD n=9 Participants Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.	GSK1349572 50 mg QD n=10 Participants Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.	Placebo n=7 Participants Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.	GSK1349572 2 mg QD n=9 Participants Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
Number of Participants With the Emergence of Drug Resistance Mutations	0 participants	0 participants	0 participants	0 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK1349572 2 mg QD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

GSK1349572 10 mg QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

GSK1349572 50 mg QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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