| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01641809 | Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine | PHASE2 | COMPLETED | 244 | — | — | Aug 6, 2012 | Jan 15, 2019 | Jan 30, 2020 | 48 | United States, Canada |
| NCT00920426 | Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929) | PHASE2 | COMPLETED | 9 | — | — | Jun 9, 2009 | Aug 13, 2009 | Dec 6, 2017 | 4 | United States |
| NCT02354937 | Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment | PHASE1 | COMPLETED | 16 | — | — | Jul 13, 2015 | Nov 1, 2016 | Aug 28, 2020 | 2 | United States |
| NCT02059031 | A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2014 | Jun 1, 2014 | Jul 16, 2014 | 1 | United States |
| NCT02027454 | Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction | PHASE1 | COMPLETED | 42 | — | — | Jan 1, 2014 | Jun 1, 2014 | Jun 16, 2014 | 1 | United States |
| NCT01754116 | A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects | PHASE1 | COMPLETED | 43 | — | — | Jan 1, 2013 | Apr 1, 2014 | Apr 21, 2014 | 1 | United States |
| NCT01593046 | A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects | PHASE1 | COMPLETED | 43 | — | — | May 1, 2012 | Nov 1, 2013 | Feb 10, 2014 | 2 | United States |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a lower limit of detection (LLOD) of 50 copies/milliliter (mL) (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for PK analysis of AUC(0-24) of GSK1265744 was collected on Day 1 (Pre-dose \[within 15 minutes prior to dosing\] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 1 (Pre-dose \[within 15 minutes prior to dosing\] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 10 (Pre-dose \[within 15 minutes prior to dosing\] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Blood samples for PK analysis of C0, Ctau and Cmin of GSK1265744 was collected on Day 10 (Pre-dose \[within 15 minutes prior to dosing\] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
Blood samples for PK analysis of Cmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
Blood samples for PK analysis of tmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
PK sampling was planned to be collected up to 24 hours only on Day 1 and Day 10. The data for this outcome measure was however not collected.
Blood samples for PK analysis of CL/F of GSK1265744 was collected on Day 10 (Pre-dose \[within 15 minutes prior to dosing\] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or is associated with liver injury and impaired liver function.
Blood samples for assessment of hematology parameters of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC- absolute neutrophil count) and white blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of hematology parameter of hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of hematology parameter of mean corpuscle hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of hematology parameter of mean corpuscle volume was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of hematology parameter of platelet count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of hematology parameter of red blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of hematology parameter of reticulocytes was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of clinical chemistry parameters of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and lipase was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of clinical chemistry parameters of direct bilirubin, total bilirubin, calcium, cholesterol, creatinine, glucose, HDL cholesterol direct, LDL cholesterol calculation, triglycerides,Urea/BUN was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Blood samples for assessment of clinical chemistry parameters of chloride, carbon dioxide content/bicarbonate, magnesium, sodium and potassium was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Samples for urinalysis assessment was collected on Day 1, Day 3 and Day 10. Urinalysis parameters included urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine pH, urine protein, urine specific gravity and urine leukocyte esterase test for detecting white blood cell.
Systolic and diastolic blood pressure was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Heart rate was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
All ECGs were obtained after a minimum 10 minute rest in a semi-supine position. The 12-lead ECGs were obtained at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10 using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and Bazett's correction (QTcB) and Fridericia correction (QTcF) intervals. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
To compare effect of severe renal impairment on PK parameters for 744 assessed by Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinity\]) and Maximum observed concentration (Cmax)
PK parameters will include area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinity\]), AUC from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC\[0-t\]), maximum observed concentration (Cmax) and concentration at 24h post-dose (C24)
PK parameters will include AUC(0-infinity), AUC(0-t), Cmax and C24
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF interval will be obtained by digital electrocardiograms (ECG) obtained through 12 lead holter monitoring machine. Triplicate ECGs will be evaluated at each time point
To evaluate the relative bioavailability of two new formulations of GSK1265744 400 mg LAP given intramuscularly compared to the current formulation (200 nm particle size) the pharmacokinetic (PK) parameters will include AUC 0 - 12
To evaluate the relative bioavailability of two new formulations of GSK1265744 400 mg LAP given intramuscularly compared to the current formulation (200 nm particle size) the PK parameters will include Cwk12
To evaluate the relative bioavailability of two new formulations of GSK1265744 400 mg LAP given intramuscularly compared to the current formulation (200 nm particle size) the PK parameters will include the maximum observed concentration
Hematology, Clinical Chemistry and Urinalysis
Blood pressure and heart rate
Hematology, Clinical Chemistry and Urinalysis
Blood pressure and heart rate
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
| Arm | Type | Description |
|---|---|---|
| Arm 1 GSK1265744 10 mg | EXPERIMENTAL | In the Induction Phase subjects will receive oral tablets of GSK1265744 10 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 10 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96. |
| Arm 2 GSK1265744 30 mg | EXPERIMENTAL | In the Induction Phase subjects will receive oral tablets of GSK1265744 30 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 30 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96. |
| Arm 3 GSK1265744 60 mg | EXPERIMENTAL | In the Induction Phase subjects will receive oral tablets of GSK1265744 60 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 60 mg + Rilpivirine 25 mg once daily from Week 24 to Week 96. |
| Arm 4 Efavirenz 600 mg | ACTIVE_COMPARATOR | In the Induction Phase and Maintenance Phase subjects will receive oral tablets of Efavirenz 600 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine). |
| GSK1265744 30 mg | EXPERIMENTAL | GSK1265744 30 mg |
| Placebo | EXPERIMENTAL | Placebo to match GSK1265744 |
| GSK1265744 5 mg | EXPERIMENTAL | GSK1265744 5 mg |
| Subjects with renal impairment | EXPERIMENTAL | Subjects with severe renal impairment will receive single oral dose of 744 30 mg |
| Subjects with normal renal function | ACTIVE_COMPARATOR | Subjects with normal renal function will receive single oral dose of 744 30 mg |
| Part A | EXPERIMENTAL | In Part A, subjects will be randomized to receive two new formulations of GSK1265744 30 mg (New formulation 1 -micronized \[B\], New formulation 2un-micronized \[C\]) and the sodium salt reference formulation 30 mg (Reference formulation \[A\]) in one of six sequences; ABC, BCA, CAB, BAC, ACB, CBA in three treatment periods under fasting condition. |
| Part B | EXPERIMENTAL | Fifteen eligible subjects completing the Part A of the study will enter in to Part B where they will receive either formulation B or C. The selected drug (B or C) will be administered under fed (moderate fat meal) condition in the fourth treatment period. |
| Sequence 1 | EXPERIMENTAL | Participants in this arm will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 2 | EXPERIMENTAL | Participants in this arm will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 3 | EXPERIMENTAL | Participants in this arm will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 4 | EXPERIMENTAL | Participants in this arm will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 5 | EXPERIMENTAL | Participants in this arm will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Sequence 6 | EXPERIMENTAL | Participants in this arm will receive treatment C in period 1, treatment B in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet). |
| Lead In Period GSK1265744 30 mg + midazolam 3mg | EXPERIMENTAL | During the lead-in period, a group of 12 subjects will receive a midazolam probe (on Day -29 and Day -14) to examine the potential of GSK265744 to inhibit or induce cytochrome P450 (CYP)3A activity. On Day -28, subjects will begin a 14 day oral dose of GSK265744 30 mg. to be taken once daily from Day-28 to Day -14. Subjects will begin a wash out period from Day -14 to Day -1 and be randomized to GSK1265744 LAP on Day 1 |
| Lead in Period GSK1265744 30mg | EXPERIMENTAL | On Day -28, subjects will begin a 14 day oral dose lead-in period. Subjects will be dispensed a 14 day supply of 30mg oral GSK1265744 to be taken once daily from Day-28 to Day -15. Subjects will begin a wash out period from Day -14 to Day -1 and be randomized to GSK1265744 LAP on Day 1 |
| Treatment A | EXPERIMENTAL | Approximately 15 subjects will be enrolled and randomized on Day 1 to receive a single dose of 400 mg GSK1265744 (Nanomilled 200 nm) LAP intramuscular suspension injection |
| Treatment B | EXPERIMENTAL | Approximately 15 subjects will be enrolled and randomized on Day 1 to receive a single dose of 400mg GSK1265744 (Nanomilled 1 micro m) LAP intramuscular suspension injection |
| Treatment C | EXPERIMENTAL | Approximately 15 subjects will be enrolled and randomized on Day 1 to receive a single dose of 400 mg GSK1265744 (Dry milling and homogenization 5 micro m) LAP intramuscular suspension injection |
| Run-in Period | EXPERIMENTAL | Oral GSK1265744 30mg once daily for 14 days |
| Cohort 1 | EXPERIMENTAL | GSK1265744 LAP injection given subcutaneously once a month for 4 months |
| Cohort 2 | EXPERIMENTAL | GSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4. |
| Cohort 3 | EXPERIMENTAL | GSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4. |
| Cohort 4 | EXPERIMENTAL | GSK1265744 LAP injection given intramuscularly once every 12 weeks. |
| Name | Type | Description |
|---|---|---|
| GSK1265744 10 mg | DRUG | GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study. |
| GSK1265744 30 mg | DRUG | GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study. |
| GSK1265744 60 mg | DRUG | GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study. |
| Efavirenz 600 mg | DRUG | Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study. |
| Rilpivirine 25 mg | DRUG | Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study. |
| Placebo | DRUG | Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study. |
| Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC) | DRUG | The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator. |
| GSK1265744 30mg | DRUG | GSK1265744 30 mg |
| GSK1265744 5mg | DRUG | GSK1265744 5mg |
| GSK1265744 Reference formulation | DRUG | GSK1265744 (micronized) reference formulation is available as 30 mg tablet to be orally administered with 240 mL of water |
| GSK1265744 New formulation 1 | DRUG | GSK1265744 (micronized) New formulation 1 is available as 30 mg tablet to be orally administered with 240 mL of water |
| GSK1265744 New formulation 2 | DRUG | GSK1265744 (un-micronized) New formulation 2 is available as 30 mg tablet to be orally administered with 240 mL of water |
| GSK1265744 | DRUG | White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses. |
| GSK1265744 matching placebo | DRUG | GSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose). |
| Moxifloxacin | DRUG | Dull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose. |
| GSK1265744 30 mg oral | DRUG | GSK1265744B 30 mg Tablet taken orally, once a day in the morning with or without a meal |
| Midazolam 3 mg oral + GSK1265744 30mg oral | DRUG | Midazolam Syrup 3mg each mL Oral/single dose administer by oral syringe on Day -29 and Day -14 |
| GSK1265744 400 mg (200 nm) | DRUG | A single dose of GSK1265744 400 mg Intra Muscular (IM) injection (Nanomilled 200 nm) |
| GSK1265744 400 mg (1 micro m) | DRUG | A single dose of GSK1265744 400 mg IM injection (Nanomilled 1 micrometer) |
| GSK1265744 400 mg (5 micro m) | DRUG | A single dose of GSK1265744 400 mg IM injection (Dry milling and homogenization 5 micrometer) |
| GSK1265744 Oral | DRUG | 30mg tablet |
| GSK1265744 LAP 800mg intramuscular injection | DRUG | 800mg Loading dose given at month 1 dose |
| GSK1265744 LAP 200mg subcutaneous injection | DRUG | 200mg maintenance dose give at months 2 - 4 |
| GSK1265744 LAP 200mg intramuscular injection | DRUG | 200mg maintenance dose given at months 2 - 4 |
| GSK1265744 LAP 400mg intramuscular injection | DRUG | 400mg maintenance dose given at month 2 - 4 |
| TMC278 LA 1200mg intramuscular injection | DRUG | 1200mg Loading dose given at month 3 |
| TMC278 LA 600mg intramuscular injection | DRUG | 600mg Loading dose given at month 4 |
Inclusion Criteria: * HIV-1 infected male or female subjects \>= 18 years of age * Screening plasma HIV-1 RNA \>=1000 c/mL * CD4+ cell count \>=200 cells/millimeter (mm)\^3 * ART-naive defined as having =\<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infecti...