Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lopinavir/Ritonavir · 11 trials · 3 indications
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.
| Arm | Type | Description |
|---|---|---|
| lopinavir/ritonavir plus lamivudine | EXPERIMENTAL | ARM 1: Lopinavir/ritonavir 200mg/50mg 2 tabs bid plus 3TC 150mg x1 tab bid |
| lopinavir/ritonavir plus two nucleosides | ACTIVE_COMPARATOR | ARM 2: 3TC 150mg x1 tab bid or FTC 200mg 1 capsule qd plus Lopinavir/ritonavir 200mg/50mg 2 tabs BID plus a second NRTI, selected at investigator's discretion, based on baseline genotype |
| LPV/r + FTC/TDF | ACTIVE_COMPARATOR | lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily |
| LPV/r + RAL | EXPERIMENTAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| 1 | ACTIVE_COMPARATOR | Kaletra Monotherapy: lopinavir/ritonavir |
| 2 | ACTIVE_COMPARATOR | Kaletra based triple therapy: lopinavir/ritonavir + lamivudine/zidovudine |
| Name | Type | Description |
|---|---|---|
| lopinavir/ritonavir plus one nucleoside | DRUG | ARM 1: Lopinavir/ritonavir 200mg/50mg 2 tabs bid plus 3TC 150mg x1 tab bid |
| lopinavir /ritonavir plus two nucleosides | DRUG | ARM 2: 3TC 150mg x1 tab bid or FTC 200mg 1 capsule qd plus Lopinavir/ritonavir 200mg/50mg 2 tabs BID plus a second NRTI, selected at investigator's discretion, based on baseline genotype. |
| lopinavir/ritonavir (LPV/r) | DRUG | LPV/r 400/100 mg BID |
| emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) | DRUG | FTC/TDF 200/300 mg QD |
| raltegravir (RAL) | DRUG | RAL 400 mg BID |
| lopinavir/ritonavir | DRUG | 400 mg lopinavir/ 100 mg ritonavir, BID |
| lamivudine/zidovudine | DRUG | 300mg lamivudine/150mg zidovudine, BID |
| Tenofovir DF | DRUG | - |
| Emtricitabine | DRUG | - |
| Ritonavir | DRUG | - |
| Nelfinavir mesylate | DRUG | - |
| Lamivudine | DRUG | - |
| Stavudine | DRUG | - |
| Nevirapine | DRUG | - |
| Saquinavir mesylate | DRUG | - |
| Efavirenz | DRUG | - |
Inclusion Criteria: 1. \> 18 years of age. 2. Patient with documented HIV-1 infection 3. Subject has voluntarily signed and dated an informed consent form 4. Subject agrees not to take any medication during the study, including over the counter medicines or herbal preparations, without the approval...
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Lopinavir/Ritonavir is used for the treatment of HIV infections, including HIV Infection and Human Immunodeficiency Virus Infection. It is a small molecule drug being developed by Abbott Laboratories for the infectious disease therapeutic area.
Lopinavir/Ritonavir is a combination of two protease inhibitors. Lopinavir is the active protease inhibitor, and ritonavir is used to boost lopinavir levels by inhibiting its metabolism. This combination targets the HIV protease enzyme, which is essential for viral replication.
Lopinavir/Ritonavir is being developed by Abbott Laboratories, a company traded under the ticker ABT. The drug is in Phase 3 clinical development for the treatment of HIV infections.
Lopinavir/Ritonavir is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of HIV infections.
Lopinavir/Ritonavir has been studied in several clinical trials, including NCT00004578, NCT00004580, NCT00038220, and NCT00043953. These trials have been completed and have evaluated the drug in HIV-infected patients, including those who are antiretroviral naive and those who have taken protease inhibitors.
Yes, Lopinavir/Ritonavir is also known as ABT-378/Ritonavir. Clinical trials have used the name ABT-378/Ritonavir to refer to the same drug combination.