CLINICAL TRIALS PROFILE FOR KALETRA

All Clinical Trials for KALETRA

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.
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.
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.

Clinical Trial Conditions for KALETRA

Condition Name

Condition Name for KALETRA
Intervention	Trials
HIV Infections	68
HIV	18
HIV Infection	17

Condition MeSH

Condition MeSH for KALETRA
Intervention	Trials
HIV Infections	101
Acquired Immunodeficiency Syndrome	30
Infections	19

Clinical Trial Locations for KALETRA

Trials by Country

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

Trials by US State

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 Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

Introduction

Kaletra, a combination of lopinavir and ritonavir, has been a cornerstone in HIV treatment since its approval in 2000. Developed by Abbott Laboratories, Kaletra was among the earliest protease inhibitors to significantly improve patient outcomes. Over the years, its role has broadened, especially during viral outbreaks such as COVID-19, where it was evaluated for repurposing. This analysis provides an updated review of Kaletra's clinical trial landscape, current market positioning, and future growth projections grounded in ongoing research and regulatory developments.

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Clinical Trials Update

Historical and Current Clinical Use

Initially approved for treating HIV-1 infection, Kaletra demonstrated high efficacy in combination therapies, reducing viral loads and increasing CD4 counts [1]. Its safety profile, though well-established, contains notable effects such as gastrointestinal disturbances and lipid abnormalities, which are manageable with clinical oversight.

Recent Clinical Trials and Research

Despite declining global utilization for HIV, Kaletra remains active in clinical investigation, primarily in the context of emerging viral infections. Notably:

• COVID-19 Therapeutic Evaluations: During the early phases of the pandemic, several trials assessed Kaletra's efficacy against SARS-CoV-2. The ACTT-1 trial by the NIH concluded that Kaletra did not significantly improve clinical outcomes compared to standard care [2]. Subsequent studies, including the World Health Organization's Solidarity trial, reaffirmed these findings, leading to a diminished role in COVID-19 management [3].

• Drug Repurposing Efforts: Ongoing trials are examining Kaletra's potential in combination therapies for various viral infections, including hepatitis C and Ebola, though these remain exploratory with limited clinical validation as of 2023.

• HIV/AIDS Optimization Studies: Current trials focus on dose optimization and long-term safety in combination regimens, especially in populations with comorbidities such as hepatitis coinfection.

Regulatory Status of Ongoing Trials

Most recent trials have received regulatory clearance for specific patient populations. The majority are Phase II or III, investigating Kaletra’s compatibility with novel agents or in special populations, e.g., pediatric or pregnant patients.

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Market Analysis

Historical Market Performance

Kaletra pioneered the protease inhibitor market, capturing significant market share during its peak in the early 2000s. Its success was driven by robust efficacy and fewer resistance issues compared to earlier antiretrovirals.

Current Market Dynamics

Several factors have impacted Kaletra’s market presence:

• Emergence of Newer Therapies: The development of integrase inhibitors (e.g., dolutegravir, bictegravir) and other fixed-dose combinations have overshadowed Kaletra. These newer agents offer improved tolerability, once-daily dosing, and fewer drug-drug interactions [4].

• Patent Expiry and Generics: Abbott’s patent for Kaletra expired in many key markets around 2014, leading to the proliferation of generic versions. This drove down prices but also reduced profit margins for original formulations.

• Regulatory and Reimbursement Landscape: While in many countries Kaletra remains available, especially in resource-limited settings, international procurement agencies such as the Global Fund now prioritize newer, more convenient agents.

• COVID-19 Impact: During the pandemic, demand for Kaletra surged temporarily due to emergency use authorizations in some regions. However, subsequent clinical evidence led to withdrawal of such authorizations, causing a decline in sales.

Market Forecast (2023–2030)

The global antiretroviral market is expected to grow at a CAGR of approximately 3.4% from 2023 to 2030, driven by increased HIV diagnoses and expanding treatment coverage, particularly in low- and middle-income countries [5].

Kaletra's role is expected to diminish further but maintain a niche in:

• Resource-limited Settings: Cost-effective generic versions remain vital in Africa, Asia, and parts of Latin America where affordability outweighs the convenience of newer agents.

• Combination Therapies: Continued research on Kaletra as part of multidrug regimens for resistant HIV strains or specific co-infections.

• COVID-19 and Emerging Viruses: Despite limited current evidence, research into Kaletra’s efficacy against novel coronaviruses or other pathogens may revive interest temporarily or in specific settings.

Future Projections and Opportunities

• Integration into Fixed-Dose Combinations: Partnering with innovative drug delivery platforms may extend Kaletra’s utility, especially via co-formulations that enhance adherence.

• Generic Market Domination: As patent protections expire, generic formulations will dominate, reinforcing Kaletra’s low-cost profile but limiting margins for original manufacturers.

• Niche Indications: Potential remains in developing countries' HIV treatment programs, especially for pediatric populations, where existing options are limited or costly.

• Research into Alternative Uses: With ongoing trials into antiviral synergies, Kaletra might find renewed relevance, particularly in emergency preparedness or drug-resistant infections.

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Key Takeaways

• Declining but Steady Role: Kaletra’s prominence in HIV therapy has waned due to competition from newer agents but persists as a cost-effective option in resource-limited settings.

• Clinical Trial Dynamics: Current investigations largely focus on HIV-specific optimization and potential repurposing; effectiveness against COVID-19 has been largely negated by robust clinical data.

• Market Trends: The global market trajectory favors next-generation therapies, though Kaletra maintains a foothold in generics and niche indications, especially in emerging economies.

• Future Opportunities: Strategic partnerships leveraging Kaletra’s existing formulation, along with innovations in drug delivery and combination therapies, could extend its market life.

• Regulatory and Competitive Landscape: Patent expiry and generic proliferation will continue to challenge profit margins but bolster accessible treatment in underserved regions.

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FAQs

1. Is Kaletra still recommended for HIV treatment?
Yes, Kaletra remains a treatment option in certain settings, especially where newer agents are unavailable or contraindicated. However, first-line therapies now generally prefer integrase inhibitors due to better tolerability and simplicity.

2. What are the main side effects associated with Kaletra?
Common adverse effects include gastrointestinal issues, lipid abnormalities, and hepatotoxicity. Regular monitoring mitigates long-term risks.

3. Has Kaletra been effective against COVID-19?
Large-scale clinical trials, including WHO's Solidarity trial, concluded Kaletra does not significantly improve COVID-19 outcomes, leading to its declining use for this indication.

4. Are there ongoing efforts to repurpose Kaletra?
Research continues for potential use in drug-resistant HIV strains and as part of combination regimens. Its role in emerging viral diseases remains experimental.

5. How does the patent expiry affect Kaletra’s market?
Patent expiration has enabled the production of generics, reducing costs and expanding access but diminishing profit margins for original manufacturers.

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References

[1] DeJesus E, et al. "Efficacy and safety of lopinavir/ritonavir in treatment-naive HIV-infected adults." Journal of Infectious Diseases, 2003.
[2] Beigel JH, et al. "Remdesivir for the Treatment of Covid-19 — Final Report." New England Journal of Medicine, 2020.
[3] WHO Solidarity Trial Consortium. "Repurposed antiviral drugs for COVID-19—interim WHO solidarity trial results." New England Journal of Medicine, 2021.
[4] Cahn P, et al. "Current and future antiretroviral therapy." The Lancet HIV, 2022.
[5] Grand View Research. "Antiretroviral Drugs Market Size, Share & Trends Analysis." 2023.

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In Summary, while Kaletra’s prominence in HIV treatment has diminished with the advent of newer therapies, it remains an important drug in specific markets and for particular patient populations. Ongoing clinical research and strategic positioning could sustain its relevance within a changing therapeutic landscape.