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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days. Serial PK sampling will be completed following the last dose of each treatment. Safety and tolerability will be assessed throughout the study through assessment of adverse events (AEs), and clinical laboratory tests.
This study will be conducted at one center in the US with healthy adult male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days. |
|
| Arm 2 | Experimental | Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1349572 | Drug | GSK1349572 is an experimental drug for the treatment of HIV. GSK1349572 is in the integrase inhibitor class. It is not yet approved by the FDA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady state plasma GSK1349572 concentration at the end of the dosing interval (CÏ„) | 28 days | |
| maximum concentration (Cmax) | 28 days | |
| area under the time-concentration curve over the dosing interval (AUC(0-Ï„)) | 28 days | |
| AUC for a 24-hour interval (AUC(0-24) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with grade 2 or higher adverse events | 28 days | |
| Steady state plasma GSK1349572 minimum plasma concentration (Cmin) | 28 days | |
| time of minimum concentration (tmin) |
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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 | Baltimore | Maryland | 21287-5554 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35604212 | Derived | Kawuma AN, Wasmann RE, Dooley KE, Boffito M, Maartens G, Denti P. Population Pharmacokinetic Model and Alternative Dosing Regimens for Dolutegravir Coadministered with Rifampicin. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0021522. doi: 10.1128/aac.00215-22. Epub 2022 May 23. |
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| Rifampin | Drug | Rifampin is approved by the FDA for the treatment of tuberculosis. |
|
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| Rifabutin | Drug | Rifabutin is approved by the FDA for the treatment of tuberculosis. |
|
|
| 28 days |
| pre-dose concentration (C0) | 28 days |
| time of maximum concentration (tmax) | 28 days |
| apparent terminal half-life (t1/2) | 28 days |
| apparent oral clearance (CL/F) | 28 days |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D012293 | Rifampin |
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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