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
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.
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.
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.
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.

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

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−

Trials by Country for LOPINAVIR; RITONAVIR
Location	Trials
United States	756
Spain	88
Thailand	66
Canada	56
South Africa	54

Trials by US State

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−

Trials by US State for LOPINAVIR; RITONAVIR
Location	Trials
California	61
New York	55
Florida	42
Texas	40
Illinois	40

Clinical Trial Progress for LOPINAVIR; RITONAVIR

Clinical Trial Phase

Clinical Trial Phase for LOPINAVIR; RITONAVIR
Clinical Trial Phase	Trials
Phase 4	90
Phase 3	76
Phase 2/Phase 3	24

Clinical Trial Status

Clinical Trial Status for LOPINAVIR; RITONAVIR
Clinical Trial Phase	Trials
Completed	219
Terminated	30
Recruiting	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	147
NIH	87

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

Introduction to Lopinavir and Ritonavir

Lopinavir and ritonavir, commonly known by the brand name Kaletra, are antiretroviral drugs used primarily in the treatment of HIV-1 infection. Ritonavir is a booster that increases the levels of lopinavir in the body, enhancing its effectiveness. Here, we will delve into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials for COVID-19

During the COVID-19 pandemic, lopinavir and ritonavir were investigated as potential treatments due to their antiviral properties.

Initial Trials and Findings

• A clinical trial conducted at the Jin Yin-Tan Hospital in Wuhan involved 199 COVID-19 patients treated with either lopinavir-ritonavir or standard care. The results showed that while the symptoms of patients treated with lopinavir-ritonavir improved faster, there was no significant difference in the primary outcome of time to clinical improvement or 28-day mortality rates compared to the standard care group[1][3].
• The trial found that the median time to clinical improvement was similar in both groups, and there were no significant differences in viral clearance or mortality rates. However, gastrointestinal adverse events were more common in the lopinavir-ritonavir group[1][3].

Limitations and Future Studies

• The effectiveness of lopinavir-ritonavir in COVID-19 treatment was limited, partly due to the delayed initiation of treatment. Subgroup analyses did not find shorter times to clinical improvement for patients who received therapy within 12 days[3].
• Despite these findings, lopinavir-ritonavir was considered for further studies, including the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, which aimed to evaluate various treatments for COVID-19[1].

Clinical Trials for HIV

Lopinavir and ritonavir have been extensively studied in the context of HIV treatment.

Efficacy and Safety

• Studies have shown that lopinavir/ritonavir, when used in combination with other antiretroviral drugs, is highly effective in reducing viral loads. Approximately 75-90% of patients achieve a viral load below 400 copies/ml after one year, and 70% maintain viral loads below 50 copies/ml after four years[4].
• Lopinavir/ritonavir has been compared to other ritonavir-boosted protease inhibitors and has demonstrated superior outcomes in some cases. For example, the MaxCmin2 study found lopinavir/ritonavir to be superior to ritonavir-boosted saquinavir[4].

Monotherapy and Combination Therapy

• Several studies have investigated the use of lopinavir/ritonavir as monotherapy or as part of a two-drug regimen. While monotherapy showed comparable virologic outcomes to triple therapy in some studies, it is generally not recommended due to a small but significant reduction in virological suppression[4].

Market Analysis

Global Market Overview

• The global lopinavir/ritonavir market is expected to grow at a 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[2].

Market Segmentation

• The market is segmented by 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 channel (hospital pharmacy, retail pharmacy, and online pharmacy)[2].

Regional Analysis

• North America dominates the lopinavir/ritonavir market due to the presence of major key players, a well-developed healthcare sector, and increasing awareness. The Asia-Pacific and European regions are also expected to grow significantly due to increasing research and development activities and growing government support[2].

Market Projections

Growth Drivers

• The market is expected to benefit from rising R&D activities, ongoing clinical trials, and growing focus by pharmaceutical companies on developing more treatment options. Increasing awareness and government initiatives will also contribute to market growth[2].

Challenges

• Despite the positive outlook, the market faces challenges such as the high cost of treatment, adverse reactions (e.g., diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia), and lack of awareness in some regions[2].

Future Outlook

Emerging Trends

• The global lopinavir/ritonavir market will continue to be influenced by emerging trends such as the development of new formulations and the expansion of distribution channels, including online pharmacies[2].

Competitive Landscape

• The market is competitive, with several key players involved in research and development. The entry of new players and the expansion of existing ones are expected to further drive market growth[2].

Key Takeaways

• Lopinavir and ritonavir have shown mixed results in clinical trials for COVID-19, with no significant benefit beyond standard care.
• In the context of HIV treatment, lopinavir/ritonavir is highly effective when used in combination with other antiretroviral drugs.
• The global market for lopinavir/ritonavir is projected to grow at a CAGR of 5% from 2021 to 2028, driven by increasing prevalence of HIV, government initiatives, and advancements in treatment options.
• The market faces challenges such as high treatment costs and adverse reactions, but emerging trends and a competitive landscape are expected to drive growth.

FAQs

What is the primary use of lopinavir and ritonavir?

Lopinavir and ritonavir are primarily used in the treatment of HIV-1 infection, often in combination with other antiretroviral drugs.

Were lopinavir and ritonavir effective in treating COVID-19?

Clinical trials showed that lopinavir and ritonavir did not provide significant benefits beyond standard care for COVID-19 patients, although they did lead to faster symptom improvement in some cases[1][3].

What are the common adverse effects of lopinavir and ritonavir?

Common adverse effects include gastrointestinal issues such as diarrhea, nausea, and vomiting, as well as hypertriglyceridemia and hypercholesterolemia[2][3].

How is the global lopinavir/ritonavir market expected to grow?

The global market is expected to grow at a CAGR of 5% from 2021 to 2028, driven by increasing prevalence of HIV, government initiatives, and advancements in treatment options[2].

Which regions dominate the lopinavir/ritonavir market?

North America currently dominates the market, but the Asia-Pacific and European regions are also expected to see significant growth due to increasing research and development activities and government support[2].

Sources

1. European Pharmaceutical Review: "Positive results from initial lopinavir-ritonavir COVID-19 clinical trial" - Hannah Balfour, April 7, 2020.
2. Data Bridge Market Research: "Global Lopinavir/ritonavir Market – Global Industry Trends and Forecast to 2028."
3. JAMA Network: "Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19)" - April 13, 2020.
4. Aidsmap: "Lopinavir/ritonavir - Aidsmap" - September 28, 2021.
5. Market Research Reports Inc.: "Lopinavir and Ritonavir - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030."