CLINICAL TRIALS PROFILE FOR KALETRA

All Clinical Trials for KALETRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00032669 ↗	Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children	Completed	National Cancer Institute (NCI)	Phase 1	2002-03-01	This study will evaluate a new treatment strategy called therapeutic drug monitoring (TDM) in HIV-infected children and adolescents. TDM involves analyzing the virus, giving drugs the virus is most sensitive to, monitoring drug blood levels to make sure there is enough drug to work against the virus, and changing the drug dose if it is too low. HIV-infected children between 0 and 21 years of age who may benefit from treatment with a protease inhibitor and who are not benefiting from their current antiretroviral drug treatment regimen may be enrolled in this 48-week study. Patients who are not currently receiving antiretroviral treatment, including patients who have never received antiretroviral treatment, may be enrolled in the study. Participants will have blood drawn to learn what anti-HIV drugs the patient's virus is resistant to-that is, what drugs are no longer effective against the virus. This is determined by analyzing the virus's genotype (detailed genetic structure) and phenotype (response to exposure to anti-viral drugs). Based on these test results and the patient's prior medication history, a drug regimen tailored to the individual patient will be prescribed. It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse transcriptase inhibitor such as nevirapine or efavirenz, and a protease inhibitor such as amprenavir, nelfinavir, saquinavir, ritonavir, or Kaletra (a combination of lopinavir and ritonavir). After the patients begin treatment, the amount of the protease inhibitor in the blood will be measured. If not enough of the drug is found in the blood, the dose of the drug will be increased and the amount of the drug in the blood will be checked again. In this study, the dose may be increased up to three times. Patients will be seen in clinic for 6 days when treatment begins to measure blood levels of the medicines and evaluate the response of the virus. Treatment will then continue on an outpatient basis. Drug levels will be measured periodically throughout the study. The viral load will also be measured and additional tests to determine whether the resistance pattern of the patients' virus has changed. In addition, patients will undergo the following tests and procedures at various times throughout the study, more frequently for the first few months and then less often: - Blood tests to measure cell counts and viral load - Routine laboratory tests to measure kidney, liver, bone marrow, and other organ functioning - Eye and neuropsychologic examinations - Echocardiogram (heart ultrasound) - Electrocardiogram (EKG - heart rhythm test) - Chest X-ray - Computed tomography (CT) scan of the head - Skin tests To make sure the medicines work, they must be taken as directed. In addition, since higher than usual doses of some of the anti-HIV drugs may be given, it will be important to know whether the patients are taking all of the medicine that has been prescribed. This study will therefore also measure patients' adherence to their medication regimen in two ways: 1) some medicines will be packaged in a bottle with an electronic medicine bottle cap that will record when the bottle is opened, and 2) patients and their parents will be interviewed by phone or in person at various times during the study about adherence and may be asked to fill out forms that record the number of doses taken. This will allow the doctor and patient to work together to make sure the medicines are being taken properly. Patients and parents will also be interviewed periodically about their understanding of HIV disease, about social supports that are available, and about the child's emotional adjustment.
NCT00038519 ↗	Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor	Completed	Abbott	Phase 2/Phase 3	2001-04-01	The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.
NCT00038220 ↗	Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients	Completed	Abbott	Phase 2	2000-07-01	The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
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.

Clinical Trial Conditions for KALETRA

Condition Name

Condition Name for KALETRA
Intervention	Trials
HIV Infections	68
HIV	18
HIV Infection	17
COVID-19	9

Condition MeSH

Condition MeSH for KALETRA
Intervention	Trials
HIV Infections	101
Acquired Immunodeficiency Syndrome	30
Infections	19
Immunologic Deficiency Syndromes	17

Clinical Trial Locations for KALETRA

Trials by Country

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Trials by Country for KALETRA
Location	Trials
United States	278
Spain	65
Canada	38
Brazil	25
South Africa	23

Trials by US State

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−

Trials by US State for KALETRA
Location	Trials
California	24
New York	18
Texas	17
Illinois	17
Florida	16

Clinical Trial Progress for KALETRA

Clinical Trial Phase

Clinical Trial Phase for KALETRA
Clinical Trial Phase	Trials
Phase 4	51
Phase 3	27
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for KALETRA
Clinical Trial Phase	Trials
Completed	108
Terminated	23
Recruiting	8

Clinical Trial Sponsors for KALETRA

Sponsor Name

Sponsor Name for KALETRA
Sponsor	Trials
Abbott	43
National Institute of Allergy and Infectious Diseases (NIAID)	14
Gilead Sciences	8

Sponsor Type

Sponsor Type for KALETRA
Sponsor	Trials
Other	187
Industry	94
NIH	34

Kaletra: Clinical Trials, Market Analysis, and Projections

Introduction

Kaletra, a combination of the antiviral drugs lopinavir and ritonavir, has been a cornerstone in the treatment of HIV-1 infection. Recently, it has also been evaluated for its potential in treating COVID-19. Here, we delve into the current state of clinical trials, market analysis, and future projections for Kaletra.

Clinical Trials Overview

HIV Treatment

Kaletra is widely used in combination with other antiretroviral medications for the treatment of HIV-1 infection in adults. It has been a staple in HIV treatment regimens due to its efficacy and relatively low side effect profile[4].

COVID-19 Trials

During the COVID-19 pandemic, Kaletra was evaluated in several clinical trials for its potential to treat severe COVID-19. However, the results were mixed. A notable study published in The New England Journal of Medicine showed that Kaletra did not offer significant benefits over standard care in patients hospitalized with severe COVID-19. Despite this, some analysts suggested that the drug might be more effective when administered early in the course of the disease[5].

Market Analysis

Current Market Size

The global HIV drugs market, which includes Kaletra, was valued at USD 34.57 billion in 2023. This market is expected to grow significantly, reaching USD 77.6 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 9.4% during the forecast period of 2025-2032[2].

Regional Dominance

North America, particularly the United States and Canada, is expected to remain a leading market for HIV drugs, including Kaletra, due to the high prevalence of HIV infections and a well-developed healthcare infrastructure. The Asia Pacific region, with countries like India and China, is also anticipated to be a significant market driven by growing awareness and supportive government initiatives[2].

Competitive Landscape

The HIV drugs market is competitive, with integrase inhibitors emerging as a key segment. However, protease inhibitors like Kaletra continue to hold a significant market share. The decision by AbbVie to not enforce global patent rights on Kaletra during the COVID-19 pandemic allowed for the production of generics, which could impact the market dynamics but also ensure broader accessibility[2][5].

Market Projections

Growth Drivers

• Increasing HIV Prevalence: The growing number of HIV patients globally is a major driver for the HIV drugs market.
• Awareness and Accessibility: Rising awareness about HIV and other chronic diseases, along with government initiatives to improve treatment accessibility, are expected to boost the market.
• Advancements in Healthcare: High investments in medical research and development, especially in regions like North America, will continue to drive innovation and growth in the HIV drugs market[2].

Challenges

• Side Effects and Toxicity: The risk of side effects and toxicity associated with antiretroviral drugs, including Kaletra, can impede market growth.
• Drug Resistance: The development of drug resistance is another challenge that the HIV drugs market faces, necessitating continuous innovation and development of new treatments[2].

Clinical Trials Market Context

U.S. Clinical Trials Market

The U.S. clinical trials market, which includes trials for HIV drugs like Kaletra, was valued at USD 25.81 billion in 2023 and is projected to grow to USD 41.57 billion by 2033, with a CAGR of 4.88%. Phase I trials, which are crucial for assessing the safety and efficacy of new drugs, are expected to exhibit the fastest growth during this period[3].

Oncology and Other Segments

While the oncology segment dominates the U.S. clinical trials market, other segments, including infectious diseases like HIV, also play a significant role. The interventional study design segment, which includes trials for drugs like Kaletra, held the largest market share in 2023 and is expected to continue growing[3].

Key Takeaways

• HIV Market Growth: The global HIV drugs market, including Kaletra, is expected to grow significantly, driven by increasing prevalence and awareness.
• Regional Focus: North America and the Asia Pacific region are key markets due to high HIV prevalence and supportive healthcare infrastructures.
• Clinical Trials: Despite mixed results in COVID-19 trials, Kaletra remains a vital drug in HIV treatment, with ongoing clinical trials ensuring its continued relevance.
• Challenges: Side effects, toxicity, and drug resistance are challenges that need to be addressed through continuous innovation.

FAQs

What is Kaletra used for?

Kaletra is used in combination with other antiretroviral medications for the treatment of HIV-1 infection in adults. It has also been evaluated for its potential in treating COVID-19.

How is the HIV drugs market expected to grow?

The global HIV drugs market is expected to grow from USD 37.82 billion in 2024 to USD 77.6 billion by 2032, with a CAGR of 9.4%.

Which regions are expected to dominate the HIV drugs market?

North America, particularly the United States and Canada, and the Asia Pacific region, especially India and China, are expected to be the leading markets.

What were the results of Kaletra in COVID-19 trials?

Kaletra did not show significant benefits over standard care in patients hospitalized with severe COVID-19 in some studies, although there is some evidence suggesting it might be more effective when administered early.

What challenges does the HIV drugs market face?

The market faces challenges such as side effects, toxicity, and drug resistance, which necessitate continuous innovation and development of new treatments.

How does the decision to not enforce patent rights on Kaletra impact the market?

The decision allows for the production of generics, ensuring broader accessibility but potentially impacting the market dynamics and the revenue of the original manufacturer.