CLINICAL TRIALS PROFILE FOR LOPINAVIR; RITONAVIR

505(b)(2) Clinical Trials for lopinavir; ritonavir

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00196625 ↗	Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 2	2000-11-01	HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.

All Clinical Trials for lopinavir; ritonavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004578 ↗	ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects	Completed	Abbott	Phase 1/Phase 2	1997-11-01	To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
NCT00006144 ↗	A Study of HIV-Disease Development in Aging	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2000-10-01	The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
NCT00014937 ↗	Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.
NCT00017992 ↗	Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV	Unknown status	Triangle Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
NCT00023218 ↗	Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to look at how 2 different anti-HIV drug treatments affect the liver. The use of anti-HIV drugs like the nucleoside reverse transcriptase inhibitors (NRTIs) may be linked to liver problems like fatty changes, scarring, abnormal liver function tests (LFTs), and lactic acidemia (an increase in lactic acid in the blood). Increased liver enzymes may mean liver damage. The way that the liver changes in people with abnormal LFTs and lactic acidemia is not completely understood.
NCT00025727 ↗	Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure	Unknown status	GlaxoSmithKline	Phase 3	2001-05-01	The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.
NCT00027339 ↗	Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient's response to anti-HIV therapy.

Clinical Trial Conditions for lopinavir; ritonavir

Condition Name

Condition Name for lopinavir; ritonavir
Intervention	Trials
HIV Infections	139
COVID-19	36
HIV	35
HIV Infection	32

Condition MeSH

Condition MeSH for lopinavir; ritonavir
Intervention	Trials
HIV Infections	195
COVID-19	69
Acquired Immunodeficiency Syndrome	44
Infections	37

Clinical Trial Locations for lopinavir; ritonavir

Trials by Country

Trials by Country for lopinavir; ritonavir
Location	Trials
United States	770
Spain	88
Thailand	66
Canada	56
South Africa	54

Trials by US State

Trials by US State for lopinavir; ritonavir
Location	Trials
California	62
New York	56
Florida	43
Texas	41
Illinois	40

Clinical Trial Progress for lopinavir; ritonavir

Clinical Trial Phase

Clinical Trial Phase for lopinavir; ritonavir
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	90
Phase 3	76

Clinical Trial Status

Clinical Trial Status for lopinavir; ritonavir
Clinical Trial Phase	Trials
Completed	219
Recruiting	31
Terminated	30

Clinical Trial Sponsors for lopinavir; ritonavir

Sponsor Name

Sponsor Name for lopinavir; ritonavir
Sponsor	Trials
Abbott	55
National Institute of Allergy and Infectious Diseases (NIAID)	52
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	20

Sponsor Type

Sponsor Type for lopinavir; ritonavir
Sponsor	Trials
Other	504
Industry	149
NIH	87

Clinical Trials Update, Market Analysis, and Projection for Lopinavir/Ritonavir

Last updated: October 27, 2025

Introduction

Lopinavir/Ritonavir (brand names: Kaletra among others) is a protease inhibitor combination initially developed for HIV treatment. The drug has garnered renewed interest due to emerging research on its potential efficacy against COVID-19, despite mixed clinical outcomes. This article provides a comprehensive analysis of recent clinical trial developments, market dynamics, and future projections for Lopinavir/Ritonavir, aiming to inform stakeholders about its evolving role in infectious disease management.

Clinical Trial Landscape: Recent Developments and Efficacy

Historical Context and Initial Trials

Lopinavir/Ritonavir received FDA approval in 2000 for HIV therapy, demonstrating potent viral suppression. Its mechanism involves inhibiting the COVID-19 main protease (Mpro), a critical enzyme in viral replication, which prompted numerous trials during the COVID-19 pandemic.

COVID-19 Clinical Trials Overview

During the early pandemic, several trials evaluated Lopinavir/Ritonavir's efficacy against SARS-CoV-2. Notably:

• WHO Solidarity Trial: This large-scale, randomized, controlled trial announced in 2020 assessed four drugs, including Lopinavir/Ritonavir. Results indicated no significant reduction in mortality or hospitalization duration compared to standard care [1].

• RECOVERY Trial (UK): Focused on hospitalized patients, found no mortality benefit when Lopinavir/Ritonavir was compared to standard care [2].

• Smaller Trials & Meta-Analyses: Many smaller studies reported mixed results, with some suggesting marginal benefits, often limited by sample size and methodological variances.

Recent and Ongoing Trials

• Phase IV and Post-Marketing Studies: Ongoing research continues to evaluate Lopinavir/Ritonavir's utility in early outpatient treatment, especially in combination with other antivirals or immunomodulators.

• Repurposing for New Indications: Investigations into its off-label use for other viral infections or novel applications are ongoing but limited.

Clinical Efficacy Summary

Despite initial optimism based on in vitro activity, contemporary high-quality clinical evidence indicates that Lopinavir/Ritonavir lacks robust efficacy against COVID-19. Its role remains confined primarily to its original indication—HIV—and into potential niche applications pending new trial outcomes.

Market Analysis: Current Status and Trends

Historical Market Performance

Lopinavir/Ritonavir enjoyed significant market share in the early 2000s, driven by its efficacy in HIV treatment. The drug was supplied globally via patent-holders such as Abbott Laboratories and subsequently through authorized generics.

Market Impact of COVID-19

The pandemic prompted a surge in repurposing efforts, temporarily increasing demand and visibility:

• Demand Spike: During 2020, several countries stockpiled Lopinavir/Ritonavir as part of COVID-19 treatment protocols, despite limited supportive evidence.

• Supply Dynamics: The increased demand strained manufacturing capacities, leading to shortages in some regions.

• Pricing and Competition: The drug's generic versions became more prominent. Pricing pressures intensified as generic competition increased.

Current Market Trends

• Diminishing Confidence: With dominant clinical trial data indicating limited efficacy, healthcare providers have reduced off-label use, diminishing demand.

• Patent and Regulatory Status: Most patents have expired globally, with mature generic markets primarily driving supply. Regulatory agencies have deprecated emergency use authorizations in favor of evidence-based approaches.

• Emerging Alternatives: The development and approval of newer antivirals (e.g., Paxlovid) have further marginalized Lopinavir/Ritonavir's market relevance against viruses like COVID-19.

HIV Treatment Market Context

In its original indication, Lopinavir/Ritonavir remains utilized in combination therapies, especially in resource-limited settings. However, newer agents with improved tolerability and dosing convenience are gradually replacing it.

Market Projection (2023-2030)

Short-Term Outlook (Next 2-3 Years)

• Stable but Limited Demand for COVID-19 Indications: As evidence dismisses its efficacy, Lopinavir/Ritonavir's use in COVID-19 is expected to decline sharply, with only niche or experimental applications.

• HIV Treatment Persistence: The drug will continue to serve as part of combination regimens in HIV management, especially in developing countries, sustaining modest but steady demand.

• Regulatory Landscape: With global health agencies emphasizing evidence-based treatments, further restrictions or de-listing for COVID-19 applications are likely.

Medium to Long-Term Outlook (2024-2030)

• Market Contraction in COVID-19 Domain: The COVID-19-specific market could diminish to negligible levels by 2025, mirroring the trajectory of other repurposed drugs that failed to demonstrate substantial clinical benefit.

• Continued Presence in HIV Regimens: The drug's role in HIV therapy remains stable, with projections indicating moderate growth driven by expanding HIV treatment programs in emerging markets.

• Potential for New Indications: Isolated research exploring Lopinavir/Ritonavir for other viral or infectious diseases may offer limited niche opportunities, but significant breakthroughs appear unlikely given current evidence.

• Pricing and Competition Dynamics: The generic landscape keeps prices low; manufacturing capacity remains robust, ensuring supply stability but limited growth potential.

Influencing Factors

• Regulatory Decisions: Adjustments in approvals based on emerging evidence will heavily influence market size.

• Innovation and Competition: Next-generation antivirals and combination therapies may further erode market share.

• Global HIV/AIDS Initiatives: Funding and policy prioritization will catalyze sustained use in HIV management, particularly in low-income countries.

Key Takeaways

• Although initially promising, Lopinavir/Ritonavir demonstrated limited efficacy against COVID-19, leading to a significant decline in its investigational and off-label use.

• The drug remains a staple in HIV treatment regimens, especially within resource-constrained settings, supporting a moderate ongoing market.

• Future projections indicate the COVID-19-related market for Lopinavir/Ritonavir will nearly vanish by 2025 due to lack of supporting clinical evidence and emerging superior therapies.

• The global HIV market offers a stable platform for continued Lopinavir/Ritonavir utilization, though competition from newer agents may temper growth.

• The drug's long-term prospects hinge on its role in HIV management and potential niche applications, with mainstream infectious disease markets unlikely to expand.

FAQs

1. Why did Lopinavir/Ritonavir gain attention during the COVID-19 pandemic?
It demonstrated in vitro activity against SARS-CoV-2 and was quickly repurposed based on its antiviral mechanism—protease inhibition—similar to other successful pandemic treatments.

2. Are there ongoing clinical trials testing Lopinavir/Ritonavir for COVID-19?
Most high-quality trials, including the WHO Solidarity and RECOVERY, have concluded, showing limited efficacy. Isolated phase IV or niche trials may still be ongoing but are unlikely to alter its market status significantly.

3. What is the primary current use of Lopinavir/Ritonavir?
Its main application remains as part of antiretroviral therapy for HIV-positive patients, especially where newer medications are unavailable.

4. How has the market for Lopinavir/Ritonavir changed post-pandemic?
The COVID-19-induced demand surge has subsided, with the drug's market now primarily driven by HIV treatment needs in developing regions.

5. What are the future outlooks for Lopinavir/Ritonavir’s market?
Steady in HIV therapy, but declining overall with diminishing relevance for COVID-19 and limited prospects for new indications.

References

[1] WHO Solidarity Trial Consortium. "Repurposed antiviral drugs for COVID-19—interim WHO SOLIDARITY trial results." NEJM, 2021.
[2] RECOVERY Collaborative Group. "Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY)." NEJM, 2020.