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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
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This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Period 1 Treatment A = Dolutegravir 50mg q24h x 5 days; Period 2 Treatment B = Rilpivirine 25mg q24h x 11; Period 3 Dolutegravir 50mg q24h + Rilpivirine q24h x 5 days |
|
| Cohort 2 | Experimental | Period 1 Treatment A = GSK1265744 30mg q24h x 12 days; Period 2 Treatment B = Rilpivirine 25mg q24h x 12; Period 3 GSK1265744 30mg q24h + Rilpivirine q24h x 12 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug | 50mg q 24h |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pharmacokinetic Parameters following Dolutegravir administration with and without rilpivirine | Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC(0-tau)), Maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax), Pre-dose (trough) concentration at the end of the dosing interval (Ctau) | Cohort 1: Period 1 and 3 on Day 5: pre-dose, 1, 2, 3, 4, 8, 12 and 24 hours post dose. |
| Composite of Pharmacokinetic Parameters following GSK1265744 administration with and without rilpivirine | steady state, AUC(0-t), Cmax, tmax, and Ctau | Cohort 2: Period 2 and 3, Day 12: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose. |
| Composite of Pharmacokinetic Parameters following rilpivirine administration with and without Dolutegravir | steady state, AUC(0-tau), Cmax, tmax, and Ctau | Cohort 1: Period 2, Day 11: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose. Period 3: Day 5 pre-dose 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose |
| Composite of Pharmacokinetic Parameters following rilpivirine administration with and without GSK1265744 | AUC(0-tau), Cmax, tmax, and Ctau | Cohort 2: Periods 1 and 3: Day 12: pre-dose, 1, 2, 3, 4, 8, 12 and 24hrs post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters, including the collection of all adverse events | Collected from first dose to final visit. | 42 days or final visit has occurred |
| Safety and tolerability parameters, including the collection of any concurrent medication from first dose to final visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23979733 | Derived | Ford SL, Gould E, Chen S, Margolis D, Spreen W, Crauwels H, Piscitelli S. Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrob Agents Chemother. 2013 Nov;57(11):5472-7. doi: 10.1128/AAC.01235-13. Epub 2013 Aug 26. |
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| Rlipivirine |
| Drug |
25mg q24h |
|
|
| GSK1265744 | Drug | 30mg q24h |
|
Collected from first dose to final visit. |
| 42 days or final visit has occurred |
| Safety and tolerability parameters, including change from baseline in clinical laboratory tests (hematology, chemistry, urinalysis) assessments | 42 days or final assessment has occurred |
| Safety and tolerability parameters, including change from baseline in ECG assessments | 42 days or final assessment has occurred |
| Safety and tolerability parameters, including change from baseline in vital signs assessments | 42 days or final assessment has occurred |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D000068696 | Rilpivirine |
| C584914 | cabotegravir |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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