KALETRA (lopinavir)
Kaletra helps patients with HIV-1 infection, including adults and infants at least 14 days old. It is used as part of a combination therapy with other antiretroviral medications to manage the virus. Healthcare providers typically use resistance testing or a patient's medical history to determine if this specific medication is the right choice for their viral profile.
How KALETRA Works
This medication works by combining lopinavir, a protease inhibitor, with ritonavir. Ritonavir acts as an inhibitor of the CYP3A enzyme, which prevents the body from breaking down lopinavir too quickly. This process maintains higher levels of lopinavir in the blood to help manage the infection.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-09-15
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, SOLUTION
KALETRA Approval History
What KALETRA Treats
1 indicationsKALETRA is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
KALETRA 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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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02369406 EIT | U01AI114235 | Ph 2, Ph 3 | active not recruiting | Early Infant HIV Treatment in Botswana |
| NCT04459702 | PRG-043 | Ph 2 | withdrawn | A Study of Combination Therapies to Treat COVID-19 Infection |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 |
| NCT01307124 | HIV-NAT 152 | Ph 3 | completed | Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL) |
| NCT01095094 results posted | CASE2307 NCI-2009-01288 | Ph 2 | terminated | Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma |
| NCT01031849 BIOKAL | HCSKAL-2009-01 2009-016090-14 | Ph 4 | terminated | Analysis of Changes in Adipose Tissue of Patients With Lipoatrophy HIV Infection Treated With Nucleoside Thymidine, After Switching to Monotherapy With Lopinavir / Ritonavir |
| 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.
KALETRA FDA Label Details
Indications & Usage
FDA Label (PDF)KALETRA is indicated for the treatment of HIV-1 Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment