LOPINAVIR AND RITONAVIR (lopinavir)
LOPINAVIR AND RITONAVIR is indicated for the treatment of HIV Infection.
How LOPINAVIR AND RITONAVIR Works
Lopinavir and ritonavir is a fixed-dose combination of two HIV-1 protease inhibitors. Lopinavir prevents the cleavage of the Gag-Pol polyprotein, resulting in the production of immature, non-infectious viral particles. Ritonavir acts as a pharmacokinetic enhancer; it inhibits the CYP3A-mediated metabolism of lopinavir, thereby increasing lopinavir plasma concentrations and improving its therapeutic efficacy.
Details
- Status
- Prescription
- First Approved
- 2016-12-27
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, PELLETS
Companies
LOPINAVIR AND RITONAVIR Approval History
What LOPINAVIR AND RITONAVIR Treats
1 indicationsLOPINAVIR AND RITONAVIR is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV Infection
LOPINAVIR AND RITONAVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04328285 COVIDAXIS | 20PH061 2020-001188-96 | Ph 3 | terminated | Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers |
| NCT04459702 | PRG-043 | Ph 2 | withdrawn | A Study of Combination Therapies to Treat COVID-19 Infection |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT02671383 DRV | WRHI052 | Ph 3 | completed | Evaluation of Low-dose Darunavir in a Switch Study |
| NCT00771498 A06-295 | A06-295 | Ph 4 | completed | An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin |
| NCT01095094 results posted | CASE2307 NCI-2009-01288 | Ph 2 | terminated | Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma |
| NCT01166477 QoLKAMON | SAI-CDV-2009-01 | Ph 4 | completed | Clinical Trial, Open-label, Randomised, in Order to Compare the Quality of Life for Those VIH+ Patients That Start With Monotherapy on LPV/r Tablets Vs. Triple Therapy With a Boosted Protease Inhibitor |
| NCT01255371 ALISA | ANRS 12221 ALISA IP.07.33011.004 | Ph 3 | withdrawn | A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOPINAVIR AND RITONAVIR FDA Label Details
Indications & Usage
FDA Label (PDF)LOPINAVIR AND RITONAVIR is indicated for the treatment of HIV Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.