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abacavir/lamivudine · 4 trials · 4 indications
Plasma PK samples will be collected pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post- dose.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 33 subjects will receive a single dose of each of a tablet formulation of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg in Period 1followed by dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg) in Period 2. Approximately 6 of these subjects will return for a third period where they will receive a single dose of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg after a high fat breakfast. There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. |
| Arm 2 | EXPERIMENTAL | 33 subjects will receive dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg) in Period 1 followed by a single dose of a tablet formulation of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg in Period 2. Approximately 6 of these subjects will return for a third period where they will receive a single dose of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg after a high fat breakfast. There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. |
| Single Arm | EXPERIMENTAL | Subjects will be randomized in a three-way crossover design to receive a single dose of each of two different tablet formulations of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg or dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg). There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. |
| Name | Type | Description |
|---|---|---|
| abacavir/lamivudine | DRUG | - |
| abacavir | DRUG | - |
| lamivudine | DRUG | - |
| tenofovir | DRUG | - |
| Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg | DRUG | Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine) |
| Dolutegravir 50 mg | DRUG | Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection. |
| abacavir 600 mg/lamivudine 300 mg | DRUG | This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors |
Inclusion Criteria: * Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at leas...
Abacavir is a small molecule drug being developed by GSK plc for the treatment of Human Immunodeficiency Virus I (HIV-1) infection. It is being studied in antiretroviral therapy experienced HIV-1 infected subjects and in healthy subjects for bioavailability studies. The drug is currently in Phase 3 clinical development.
Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) that works by inhibiting the reverse transcriptase enzyme of HIV, thereby blocking viral replication. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Abacavir is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV-1 infection.
Abacavir is in Phase 3 clinical development for the treatment of HIV-1 infection. It has completed two Phase 3 trials, NCT00044577 and NCT00046176, which evaluated the drug in antiretroviral therapy experienced HIV-1 infected subjects.
Abacavir has been studied in several clinical trials, including two Phase 3 trials: NCT00044577, which enrolled 166 participants in the US, Belgium, Canada, France, Germany, Italy, Portugal, Spain, and the UK, and NCT00046176, which enrolled 240 participants in the US, Costa Rica, Panama, and Puerto Rico. Both trials have been completed.
Abacavir is a component of a fixed-dose combination tablet containing dolutegravir, abacavir, and lamivudine. A Phase 1 trial, NCT01366547, studied the relative bioavailability of two new dolutegravir/abacavir/lamivudine fixed-dose combination tablets in healthy subjects and HIV-infected individuals.