Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darunavir · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 2 | EXPERIMENTAL | All subjects will receive GSK1349572 50mg q24h (Treatment A) from Day 1 to Day 5 in Period 1. There will be no washout between treatment Periods 1 and 2. Subjects will receive GSK1349572 50mg q24h and ETV/DRV/RTV 200/600/100mg q12h from Day 1 to Day 14 in Period 2. Day 1 of Period 3 will be approximately 3 weeks after the last dose in Period 2. Subjects will receive GSK1349572 50mg q12h and ETV/DRV/RTV 200/600/100mg q12h from Day 1 to Day 14. Period 3 will not be performed if there is no significant interaction in Period 2. |
| Cohort 1 | EXPERIMENTAL | All subjects will receive GSK1349572 50mg q24h (Treatment A) from Day 1 to Day 5 in Period 1. There will be no washout between treatment Periods 1 and 2. Subjects will receive GSK1349572 50mg q24h and ETV/LPV/RTV 200/400/100mg q12h from Day 1 to Day 14 in Period 2. Day 1 of Period 3 will be approximately 3 weeks after the last dose in Period 2. Subjects will receive GSK1349572 50mg q12h and ETV/LPV/RTV 200/400/100mg q12h from Day 1 to Day 14. Period 3 will not be performed if there is no significant interaction in Period 2. |
| Name | Type | Description |
|---|---|---|
| Darunavir | DRUG | Darunavir 600 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Darunavir is approved by the FDA as an HIV medication in the protease inhibitor class. |
| Etravirine | DRUG | Etravirine 200 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Etravirine is approved by the FDA as an HIV medication in the non-nucleoside reuptake inhibitor class. |
| Ritonavir | DRUG | Ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class. |
| Lopinavir/ritonavir | DRUG | Lopinavir 400 mg and ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Lopinavir/Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class. |
| GSK1349572 | DRUG | GSK1349572 50 q24h for 5 days in Period 1 and for 14 days in Period 2. GSK1349572 20 mg q12h for 14 days in Period 3 if Period 3 is done. GSK1349572 is an investigational (not approved by the FDA) HIV medication in the integrase inhibitor class. |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male or female between 18 and 65 years of age, inclusive. * A female subject is eligible ...
Darunavir is a small molecule drug being studied in healthy subjects and healthy volunteers. It is being investigated in clinical trials for potential use in treating Human Immunodeficiency Virus (HIV) infection. The drug is currently in Phase 1 clinical development.
Darunavir is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and interactions in healthy volunteers.
Darunavir is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and drug interactions.
Darunavir has been studied in two completed Phase 1 clinical trials. NCT00867152 evaluated drug interactions with etravirine and either darunavir/ritonavir or lopinavir/ritonavir. NCT00920088 studied drug interactions of darunavir/ritonavir and lopinavir/ritonavir on GSK2248761 pharmacokinetics and CYP450 probe drugs.
Darunavir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has been studied in clinical trials involving healthy volunteers, but it has not received regulatory approval for any medical use.
Darunavir is a small molecule drug being studied for its potential effects in healthy subjects. The specific molecular target of Darunavir has not been disclosed in the available clinical trial information. The drug is being evaluated for its safety and drug interactions in early-stage trials.