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Lopinavir/ritonavir and ritonavir
Lopinavir and ritonavir are HIV protease inhibitors that block the viral protease enzyme, preventing the maturation of HIV particles and reducing viral replication.
Lopinavir and ritonavir are HIV protease inhibitors that block the viral protease enzyme, preventing the maturation of HIV particles and reducing viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients, HIV-1 infection in combination with other antiretroviral agents.
At a glance
| Generic name | Lopinavir/ritonavir and ritonavir |
|---|---|
| Also known as | Kaletra, Norvir |
| Sponsor | University of Miami |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Lopinavir is a potent HIV protease inhibitor that binds to the active site of HIV protease, preventing the cleavage of viral polyproteins necessary for infectious particle formation. Ritonavir is a protease inhibitor used as a pharmacokinetic booster that inhibits cytochrome P450 metabolism, significantly increasing lopinavir plasma concentrations and bioavailability. Together, they form a highly effective antiretroviral combination for suppressing HIV replication.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients
- COVID-19 (investigational use during pandemic)
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Headache
- Lipid abnormalities (elevated cholesterol/triglycerides)
- Hyperglycemia
- Hepatotoxicity
Key clinical trials
- A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen (PHASE4)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Early Infant HIV Treatment in Botswana (PHASE2, PHASE3)
- Lopinavir/Ritonavir in PLWH With High-Grade AIN (PHASE1)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lopinavir/ritonavir and ritonavir CI brief — competitive landscape report
- Lopinavir/ritonavir and ritonavir updates RSS · CI watch RSS
- University of Miami portfolio CI