Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02178592 | Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection | PHASE3 | COMPLETED | 113 | — | — | Jan 23, 2015 | Mar 6, 2020 | Jan 12, 2021 | 28 | Argentina, Brazil +5 |
| NCT02075593 | ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection | PHASE3 | COMPLETED | 4 | — | — | Dec 17, 2014 | Sep 15, 2021 | Oct 6, 2022 | 3 | Russia, Spain |
| NCT02893488 | Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet | PHASE1 | COMPLETED | 20 | — | — | Sep 1, 2016 | Nov 25, 2016 | Aug 4, 2017 | 1 | United States |
| NCT02741557 | Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV) | PHASE1 | COMPLETED | 118 | — | — | May 11, 2016 | Oct 24, 2016 | Jul 15, 2019 | 1 | United States |
| NCT02373930 | Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects | PHASE1 | COMPLETED | 63 | — | — | Feb 1, 2015 | Sep 1, 2015 | Jun 27, 2016 | 1 | United States |
| NCT02082808 | Study to Evaluate the Drug Interaction Between Dolutegravir (DTG) and Daclatasvir (DCV) in Healthy Adult Subjects | PHASE1 | COMPLETED | 12 | — | — | Mar 1, 2014 | May 1, 2014 | Jun 9, 2014 | 1 | United States |
| NCT01967771 | Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects | PHASE1 | COMPLETED | 16 | — | — | Oct 1, 2013 | Jan 1, 2014 | Jan 27, 2014 | 1 | United States |
| NCT01563328 | A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697). | PHASE1 | COMPLETED | 32 | — | — | Mar 1, 2012 | May 1, 2012 | Mar 28, 2017 | 1 | United States |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product \[IP\] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.
Blood samples were collected at indicated timepoints for Pharmacokinetic (PK) analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Blood samples were collected at indicated timepoints for PK analysis of dolutegravir at Trimester 2 (Weeks 18-26 of pregnancy), Trimester 3 (Weeks 30-36 of pregnancy) and at 8-12 Weeks postpartum.
Blood samples were collected for analysis of hemoglobin. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Number of participants (Pregnant Women) with maximum severity of post-Baseline emergent toxicities with respect to hemoglobin has been presented.
Blood samples were collected for the analysis of chemistry parameters including ALT and AST.
Blood samples were collected for the analysis of chemistry parameters including ALT and AST. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine.
Blood samples were collected for the analysis of chemistry parameters including Bilirubin and Creatinine. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Blood samples were collected for the analysis of hematology parameters including hemoglobin.
Blood samples were collected for the analysis of hematology parameters including hemoglobin. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets.
Blood samples were collected for the analysis of hematology parameters including leukocytes and platelets. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment. Number of participants (pregnant women) who discontinued the treatment due to adverse events have been presented.
Data for participants (pregnant women) demonstrated congenital malformations was reported.
Number of participants (pregnant women) with adverse events (AE) as per severity grades were presented. Grade 1 is mild, grade 2 is moderate, grade 3 is severe or medically significant but not immediately life-threatening and grade 4 is life-threatening consequences; urgent intervention required.
Blood samples will be collected at pre-dose and at specific post-dose time points for calculating AUC \[0- infinity\]
Blood samples will be collected at pre-dose and at specific post dose time points for calculating Cmax
PK parameters will include area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-Infinity\]), maximum observed concentration (Cmax) and apparent oral clearance (CL/F)
PK parameters will include AUC (0-Infinity), Cmax and CL/F
PK parameters will include AUC (0-Infinity), Cmax and CL/F
Plasma PK parameters for DTG include steady state area under the concentration-time curve over the dosing interval (AUC (0-tau)), maximum observed concentration (Cmax), concentration at the end of the dosing interval (Ctau), apparent clearance following oral dosing (CL/F) and terminal phase half-life (t1/2) , following DTG 50 mg q24h administration with and without DCV 60mg q24h
Plasma DCV steady state AUC(0-tau), Cmax, Ctau, CL/F and t1/2 following administration of DCV 60 mg q24h with and without DTG 50 mg q24h
PK parameters will include: Steady state plasma DTG concentration at the end of the dosing interval (Ctau), maximum concentration (Cmax), area under the time-concentration curve over the dosing interval \[AUC(0-tau)\], apparent clearance following oral dosing (CL/F), terminal phase half life (t1/2), concentration at time zero (C0) and minimum concentration (Cmin)
Samples will be collected at predose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose
| Arm | Type | Description |
|---|---|---|
| Dolutegravir | EXPERIMENTAL | Twice-daily DTG 50 mg plus dual NRTI during RIF-containing TB treatment (isoniazid, RIF, pyrazinamide and ethambutol standard doses by the NTP under program conditions or acceptable alternative RIF-containing regimens) and for 2 weeks following discontinuation of TB treatment, then once-daily DTG 50 mg with the same NRTI through Week 52 |
| Efavirenz | ACTIVE_COMPARATOR | Once-daily EFV 600 mg plus dual NRTI through Week 52 along with TB treatment including isoniazid, RIF, pyrazinamide and ethambutol standard doses by the NTP under program conditions. |
| DTG/ABC/3TC | EXPERIMENTAL | All subjects will be administered DTG 50 milligrams (mg)/ABC 600 mg/3TC 300 mg FDC tablet once daily, with or without food. |
| SEQUENCE ABCDE | EXPERIMENTAL | Participants will receive treatment A in period 1, treatment B in period 2, treatment C in period 3, treatment D in period 4 and treatment E in period 5 (one treatment per period). Where A=EPZICOM (ABC 600 milligrams (mg)/3TC 300 mg) plus four TIVICAY (DTG 10 mg) tablets with zero mineral content (ZMC) water. B=Four TRIUMEQ (ABC 150mg/DTG 10 mg/3TC 75 mg) tablets dispersed in 40 milliliter (mL) stock solution 1 and consumed immediately. C=Four TRIUMEQ tablets dispersed in 40 mL stock solution 1, held for 30 minutes(mins), re-dispersed, and then consumed. D=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2 and consumed immediately. E=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2, held for 30 mins, re-dispersed, and then consumed. |
| SEQUENCE BCDEA | EXPERIMENTAL | Participants will receive treatment B in period 1, treatment C in period 2, treatment D in period 3, treatment E in period 4 and treatment A in period 5 (one treatment per period). Where A= EPZICOM (ABC 600 milligrams (mg)/3TC 300 mg) plus four TIVICAY (DTG 10 mg) tablets with ZMC water. B=Four TRIUMEQ (ABC 150mg/DTG 10 mg/3TC 75 mg) tablets dispersed in 40 mL stock solution 1 and consumed immediately. C=Four TRIUMEQ tablets dispersed in 40 mL stock solution 1, held for 30 mins, re-dispersed, and then consumed. D=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2 and consumed immediately. E=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2, held for 30 mins, re-dispersed, and then consumed. |
| SEQUENCE CDEAB | EXPERIMENTAL | Participants will receive treatment C in period 1, treatment D in period 2, treatment E in period 3, treatment A in period 4 and treatment B in period 5 (one treatment per period). Where A=EPZICOM (ABC 600 milligrams (mg)/3TC 300 mg) plus four TIVICAY (DTG 10 mg) tablets with ZMC water. B=Four TRIUMEQ (ABC 150mg/DTG 10 mg/3TC 75 mg) tablets dispersed in 40 mL stock solution 1 and consumed immediately. C=Four TRIUMEQ tablets dispersed in 40 mL stock solution 1, held for 30 mins, re-dispersed, and then consumed. D=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2 and consumed immediately. E=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2, held for 30 mins, re-dispersed, and then consumed. |
| SEQUENCE DEABC | EXPERIMENTAL | Participants will receive treatment D in period 1, treatment E in period 2, treatment A in period 3, treatment B in period 4 and treatment C in period 5 (one treatment per period). Where A=EPZICOM (ABC 600 milligrams (mg)/3TC 300 mg) plus four TIVICAY (DTG 10 mg) tablets with ZMC water. B=Four TRIUMEQ (ABC 150mg/DTG 10 mg/3TC 75 mg) tablets dispersed in 40 mL stock solution 1 and consumed immediately. C=Four TRIUMEQ tablets dispersed in 40 mL stock solution 1, held for 30 mins, re-dispersed, and then consumed. D=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2 and consumed immediately. E=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2, held for 30 mins, re-dispersed, and then consumed. |
| SEQUENCE EABCD | EXPERIMENTAL | Participants will receive treatment E in period 1, treatment A in period 2, treatment B in period 3, treatment C in period 4 and treatment D in period 5 (one treatment per period). Where A=EPZICOM (ABC 600 milligrams (mg)/3TC 300 mg) plus four TIVICAY (DTG 10 mg) tablets with ZMC water. B=Four TRIUMEQ (ABC 150mg/DTG 10 mg/3TC 75 mg) tablets dispersed in 40 mL stock solution 1 and consumed immediately. C=Four TRIUMEQ tablets dispersed in 40 mL stock solution 1, held for 30 mins, re-dispersed, and then consumed. D=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2 and consumed immediately. E=Four TRIUMEQ tablets dispersed in 40 mL stock solution 2, held for 30 mins, re-dispersed, and then consumed. |
| DTG/RPV FDC-DTG plus RPV | EXPERIMENTAL | Subjects will receive a single oral dose of DTG/RPV 50 mg/25 mg FDC tablet in Period 1 under fed state. After a washout period of at least 21 days, subjects will receive a single oral dose of separate tablet formulations of DTG 50 mg and RPV 25 mg together in Period 2 under fed state. |
| DTG plus RPV-DTG/RPV FDC | EXPERIMENTAL | Subjects will receive a single oral dose of separate tablet formulations of DTG 50 mg and RPV 25 mg together in Period 1 under fed state. After a washout period of at least 21 days, subjects will receive a single oral dose of DTG/RPV 50 mg/25 mg FDC tablet in Period 2 under fed state. |
| Part 1 Cohort 1- Sequence 1 | EXPERIMENTAL | Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), Treatment B (DTG/RPV 50 mg/25 mg: Product Code AS) and Treatment C (DTG/RPV 50 mg/25 mg: Product Code AM) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state. |
| Part 1 Cohort 1- Sequence 2 | EXPERIMENTAL | Each subject will receive a single dose of Treatment D (DTG/RPV 50 mg/25 mg: Product Code AQ), Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) and Treatment B (DTG/RPV 50 mg/25 mg: Product Code AS) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state. |
| Part 1 Cohort 1- Sequence 3 | EXPERIMENTAL | Each subject will receive a single dose of Treatment B (DTG/RPV 50 mg/25 mg: Product Code AS), Treatment E (DTG/RPV 50 mg/25 mg: Product Code AK) and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state. |
| Part 1 Cohort 1- Sequence 4 | EXPERIMENTAL | Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), Treatment C (DTG/RPV 50 mg/25 mg: Product Code AM) and Treatment D (DTG/RPV 50 mg/25 mg: Product Code AQ) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state. |
| Part 1 Cohort 1- Sequence 5 | EXPERIMENTAL | Each subject will receive a single dose of Treatment C (DTG/RPV 50 mg/25 mg: Product Code AM), Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), and Treatment E (DTG/RPV 50 mg/25 mg: Product Code AK) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state. |
| Part 1 Cohort 1- Sequence 6 | EXPERIMENTAL | Each subject will receive a single dose of Treatment E (DTG/RPV 50 mg/25 mg: Product Code AK), Treatment D (DTG/RPV 50 mg/25 mg: Product Code AQ) and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state. |
| Part 2 Cohort 2- Sequence 1 | EXPERIMENTAL | Each subject will receive a single dose of Treatment F (DTG/RPV FDC-1) in fasted state, Treatment F (DTG/RPV FDC-1) in fed state and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 2- Sequence 2 | EXPERIMENTAL | Each subject will receive a single dose of Treatment F (DTG/RPV FDC-1) in fed state, Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment F (DTG/RPV FDC-1) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 2- Sequence 3 | EXPERIMENTAL | Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state, Treatment F (DTG/RPV FDC-1) in fasted state and Treatment F (DTG/RPV FDC-1) in fed state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 3- Sequence 4 | EXPERIMENTAL | Each subject will receive a single dose of Treatment G (DTG/RPV FDC-2) in fasted state, Treatment G (DTG/RPV FDC-2) in fed state and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 3- Sequence 5 | EXPERIMENTAL | Each subject will receive a single dose of Treatment G (DTG/RPV FDC-2) in fed state, Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment G (DTG/RPV FDC-2) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 3- Sequence 6 | EXPERIMENTAL | Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment G (DTG/RPV FDC-2) fasted state and Treatment G (DTG/RPV FDC-2) in fed state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 4- Sequence 7 | EXPERIMENTAL | Each subject will receive a single dose of Treatment H (DTG/RPV FDC-3) in fasted state, Treatment H (DTG/RPV FDC-3) in fed state and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 4- Sequence 8 | EXPERIMENTAL | Each subject will receive a single dose of Treatment H (DTG/RPV FDC-3) in fed state, Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment H (DTG/RPV FDC-3) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Part 2 Cohort 4- Sequence 9 | EXPERIMENTAL | Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment H (DTG/RPV FDC-3) fasted state and Treatment H (DTG/RPV FDC-3) in fed state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. |
| Sequence 1 | EXPERIMENTAL | Participants will receive the study Treatment A for 5 days (DTG 50mg q24h) in Period 1 followed by a washout period (\>=7days) and Treatment B for 5 days (DCV 60mg q24h) in Period 2 and Treatment C (DCV 60mg q24h + DTG 50mg q24h) for 5 days in Period 3 |
| Sequence 2 | EXPERIMENTAL | Participants will receive the study Treatment B for 5 days (DCV 60mg q24h) in Period 1 followed by a washout period (\>=7days) and Treatment A for 5 days (DTG 50mg q24h) in Period 2 and Treatment C (DCV 60mg q24h + DTG 50mg q24h) for 5 days in Period 3 |
| DTG/CBZ | EXPERIMENTAL | All subjects will be assigned to a single-sequence of three treatment periods without washout. Subjects will receive DTG 50 mg once daily (OD) for 5 days (Period 1), followed by CBZ 100 mg twice daily (BID) for 3 days (days 1-3 of Period 2), CBZ 200 mg BID for 3 days (days 4-6 of Period 2), CBZ 300mg BID for 10 days (days 7-16 of Period 2), followed by DTG 50 mg OD in combination with CBZ 300mg BID for 5 days (Period 3). |
| Cohort 1 | EXPERIMENTAL | DTG x 5 days followed by BCV + DTG x 10 days |
| Cohort 2 | EXPERIMENTAL | DTG x 5 days followed by TVR + DTG x 10 days |
| Name | Type | Description |
|---|---|---|
| DTG 50 mg | DRUG | DTG is available as 50 mg film-coated tablet. DTG may be administered with or without food |
| EFV 600 mg | DRUG | EFV is supplied as film-coated capsule-shaped oral tablet containing 600 mg of EFV and must be administered without food |
| DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets | DRUG | The DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablet is a purple, oval, biconvex tablets. The tablet contains 52.6 mg DTG sodium which is equivalent to 50 mg DTG free acid, 702 mg ABC sulphate which is equivalent to 600 mg ABC and 300 mg 3TC. |
| DTG/ABC/3TC FDC DISPERSIBLE TABLET | DRUG | DTG/ABC/3TC FDC dispersible tablet |
| EPZICOM (ABC/3TC) | DRUG | EPZICOM will be available as orange, film coated, modified capsule shaped tablets, debossed with "GS FC2" on one side. |
| TIVICAY (DTG) | DRUG | TIVICAY will be available as white, round, biconvex tablets |
| DTG | DRUG | DTG is provided as a white, film-coated, round tablet containing DTG 50 mg, debossed with SV 572 on one side and 50 on the other side. Subjects will receive a single oral dose of DTG 50 mg tablet with 240 mL of water. |
| RPV | DRUG | RPV is provided as a white to off-white, film-coated, round, biconvex tablet containing RPV 25 mg, debossed with TMC on one side and 25 on the other side. Subjects will receive a single oral dose of RPV 25 mg tablet with 240 mL of water. |
| DTG/RPV FDC | DRUG | DTG/RPV FDC is provided as a pink, film coated, oval biconvex tablet containing FDC of DTG 50 mg and RPV 25 mg, debossed with SV J3T on one face. Subjects will receive a single oral dose of DTG/RPV 50 mg/25 mg FDC tablet with 240 mL of water. |
| RPV 25 mg | DRUG | Rilpivirine will be supplied as a white to off-white, film-coated, round biconvex tablet with a unit dose strength of 25 mg to be administered orally |
| DTG/RPV 50 mg/25 mg: Product Code AS | DRUG | DTG/RPV will be supplied as a pink, film coated, round biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally |
| DTG/RPV 50 mg/25 mg: Product Code AM | DRUG | DTG/RPV will be supplied as a pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally |
| DTG/RPV 50 mg/25 mg: Product Code AQ | DRUG | DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally |
| DTG/RPV 50 mg/25 mg: Product Code AK | DRUG | DTG/RPV will be supplied as pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally |
| DTG/RPV 50 mg/25 mg: Product Code AR | DRUG | DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally |
| DCV | DRUG | DCV is provided as a plain, green, biconvex, pentagonal film-coated tablet |
| CBZ | DRUG | CBZ will be supplied as 100 mg and 200 mg extended release tablet to be administered orally |
| BCV | DRUG | 800 mg q8h |
| TVR | DRUG | 750 mg q8h |
Inclusion Criteria: * Subject or the subject's legal representative is willing and able to understand and provide signed and dated written informed consent prior to Screening * Adult subject (at least 18 years of age) with plasma HIV-1 RNA\>=1000 copies/ milliliter (mL) at Screening * CD4+ cell cou...