CLINICAL TRIALS PROFILE FOR LOPINAVIR AND RITONAVIR

505(b)(2) Clinical Trials for Lopinavir And 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 And 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.

Clinical Trial Conditions for Lopinavir And Ritonavir

Condition Name

Condition Name for Lopinavir And Ritonavir
Intervention	Trials
HIV Infections	139
COVID-19	36
HIV	35
HIV Infection	32

Condition MeSH

Condition MeSH for Lopinavir And Ritonavir
Intervention	Trials
HIV Infections	195
COVID-19	69
Acquired Immunodeficiency Syndrome	44
Infections	37

Clinical Trial Locations for Lopinavir And Ritonavir

Trials by Country

Trials by Country for Lopinavir And Ritonavir
Location	Trials
United States	756
Spain	88
Thailand	66
Canada	56
South Africa	54

Trials by US State

Trials by US State for Lopinavir And Ritonavir
Location	Trials
California	61
New York	55
Florida	42
Texas	40
Illinois	40

Clinical Trial Progress for Lopinavir And Ritonavir

Clinical Trial Phase

Clinical Trial Phase for Lopinavir And Ritonavir
Clinical Trial Phase	Trials
Phase 4	90
Phase 3	76
Phase 2/Phase 3	24

Clinical Trial Status

Clinical Trial Status for Lopinavir And Ritonavir
Clinical Trial Phase	Trials
Completed	219
Recruiting	30
Terminated	30

Clinical Trial Sponsors for Lopinavir And Ritonavir

Sponsor Name

Sponsor Name for Lopinavir And 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 And Ritonavir
Sponsor	Trials
Other	504
Industry	147
NIH	87

Lopinavir and Ritonavir: Clinical Trials, Market Analysis, and Projections

Last updated: January 4, 2025

Introduction

Lopinavir and ritonavir, commonly known as Kaletra, is a combination drug used primarily in the treatment of HIV-1 infection. This article delves into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy in HIV Treatment

Lopinavir/ritonavir has been extensively studied and proven to be highly effective in treating both antiretroviral-naive and -experienced patients. Multiple clinical trials, such as the M97-720 and M98-863 studies, have demonstrated its superiority over other protease inhibitors. For instance, the M97-720 study showed that after 48 weeks, 85% of patients achieved HIV-1 RNA levels below 400 copies/mL, and 78% achieved levels below 50 copies/mL[3].

Long-Term Efficacy

Long-term follow-up studies have reinforced the drug's efficacy. The M97-720 study followed patients for over 6 years, showing sustained viral suppression and significant increases in CD4 cell counts[3].

Pediatric and Adult Populations

Lopinavir/ritonavir has also been found to be effective and well-tolerated in pediatric populations, similar to its performance in adult patients[3].

Safety Profile

The safety profile of lopinavir/ritonavir has been well-characterized through numerous clinical trials. Common adverse events include gastrointestinal issues such as diarrhea, nausea, and abnormal stools. Laboratory abnormalities often involve elevations in lipid profiles and, less commonly, hepatic transaminases. Despite these side effects, the drug is relatively well-tolerated, with low discontinuation rates due to adverse events[3].

Use in COVID-19 Treatment

Solidarity Trial

The World Health Organization's (WHO) Solidarity Trial investigated the use of lopinavir/ritonavir in treating COVID-19. However, the trial was discontinued due to interim results showing little or no reduction in mortality among hospitalized COVID-19 patients compared to standard care[1].

RECOVERY Trial

The RECOVERY trial, conducted in the UK, also found no beneficial effect of lopinavir/ritonavir in patients hospitalized with COVID-19. The trial concluded that there was no significant difference in 28-day mortality or other clinical outcomes between patients treated with lopinavir/ritonavir and those receiving usual care[4].

Market Analysis and Projections

Global Market Growth

The global lopinavir/ritonavir market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5% from 2021 to 2028. This growth is driven by factors such as the increasing prevalence of HIV, growing government initiatives, advancements in treatment options, and rising awareness about the disease[2].

Market Segmentation

The market is segmented based on type (antiretroviral and protease inhibitor), dosage (tablet, capsule, oral solution), route of administration (oral and other), application (HIV-1 and others), demographic (adult and pediatric), end-users (clinic, hospital, and others), and distribution channels (hospital pharmacy, retail pharmacy, and online pharmacy)[2].

Regional Dominance

North America currently dominates the lopinavir/ritonavir market due to the presence of major pharmaceutical companies, a well-developed healthcare sector, and increasing awareness. The Asia-Pacific and European regions are also expected to see significant growth due to increasing research and development activities and growing government support[2].

Challenges and Opportunities

Challenges

Despite the market growth, several challenges exist, including the high cost of treatment, adverse reactions such as diarrhea and lipid profile elevations, and a lack of awareness in some regions. These factors can hamper market growth and pose challenges for the global lopinavir/ritonavir market[2].

Opportunities

Rising R&D activities and ongoing clinical trials offer beneficial opportunities for the market. The focus of pharmaceutical companies on developing more treatment options and the growing investment in the healthcare sector are expected to drive market expansion[2].

Key Takeaways

• Clinical Efficacy: Lopinavir/ritonavir is highly effective in treating HIV-1 infection, with long-term efficacy and safety demonstrated in multiple clinical trials.
• COVID-19 Treatment: The drug has shown no beneficial effect in treating COVID-19 in hospitalized patients.
• Market Growth: The global market is expected to grow at a CAGR of 5% from 2021 to 2028, driven by increasing disease prevalence and advancements in treatment.
• Challenges and Opportunities: High treatment costs and adverse reactions are challenges, while R&D activities and growing healthcare investments present opportunities.

FAQs

What is the primary use of lopinavir/ritonavir?

Lopinavir/ritonavir is primarily used in the treatment of HIV-1 infection, acting as a protease inhibitor to block the replication of the virus.

Did lopinavir/ritonavir show any benefit in COVID-19 treatment?

No, clinical trials such as the Solidarity Trial and the RECOVERY trial found no beneficial effect of lopinavir/ritonavir in treating COVID-19 in hospitalized patients[1][4].

What are the common side effects of lopinavir/ritonavir?

Common side effects include gastrointestinal issues like diarrhea, nausea, and abnormal stools, as well as laboratory abnormalities such as elevations in lipid profiles and hepatic transaminases[3].

Which regions dominate the lopinavir/ritonavir market?

North America currently dominates the market, but the Asia-Pacific and European regions are expected to grow significantly due to increasing R&D activities and government support[2].

What drives the growth of the lopinavir/ritonavir market?

The market growth is driven by factors such as the increasing prevalence of HIV, growing government initiatives, advancements in treatment options, and rising awareness about the disease[2].

Sources

1. WHO discontinues hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19. World Health Organization, July 4, 2020.
2. Global Lopinavir/ritonavir Market – Global Industry Trends and Forecast to 2028. Data Bridge Market Research.
3. Safety and antiviral activity of lopinavir/ritonavir-based therapy in HIV infection. Journal of Antimicrobial Chemotherapy, June 30, 2005.
4. RECOVERY Trial Statement on Lopinavir-Ritonavir. RECOVERY Trial, June 29, 2020.
5. Lopinavir/ritonavir. Aidsmap, September 28, 2021.