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.
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.
NCT00038532 ↗	Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART	Completed	Abbott	Phase 2	2001-04-01	The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.
NCT00052117 ↗	Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens	Completed	Pfizer	Phase 2	2003-01-01	This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.
NCT00056641 ↗	Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients	Completed	Boehringer Ingelheim	Phase 2	2003-01-01	This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients. The primary objective is to determine the safety and pharmacokinetics of: TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

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

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 (lopinavir/ritonavir): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 6, 2026

What is KALETRA and what is its current clinical positioning?

KALETRA is the branded combination of lopinavir (LPV) + ritonavir (RTV). It is marketed by AbbVie and used in HIV treatment regimens, including in populations where protease inhibitor–based therapy remains relevant.

Clinical positioning (high level):

• KALETRA has moved into late-stage market life in many jurisdictions due to uptake of newer antiretrovirals with improved tolerability, dosing convenience, and resistance profiles.
• Ongoing clinical activity in recent years tends to be label maintenance, real-world evidence, special population analyses, or new regimen evaluation rather than de novo Phase 1 to Phase 3 development at scale. (This is consistent with typical lifecycle patterns for established HIV protease inhibitor combinations.)

Core efficacy reference standard:

• KALETRA efficacy historically anchors to protease inhibition and has extensive evidence for viral suppression in combination therapy settings. The modern clinical question is less whether KALETRA works and more who continues to use it and how it performs versus current standards of care.

What is the current clinical trials update for KALETRA?

A full, instruction-compliant “clinical trials update” requires a trial-by-trial enumeration (study ID, phase, design, status, start/completion dates, endpoints, sites, and sponsor). No such dataset was provided in the prompt, and a complete enumeration cannot be produced without it.

How large is the KALETRA market and what are the demand drivers?

Market demand is primarily driven by:

• Persisting HIV patient populations on protease inhibitor–based regimens (including where treatment history supports ongoing PI use).
• Supply and formulary inclusion (public tender and national procurement patterns, especially in high-burden countries).
• Guideline stance for protease inhibitors in specific scenarios (pregnancy, treatment-experienced populations, drug-drug interaction handling via ritonavir boosting).

Counterweights to growth:

• Shift of guideline-preferred therapy toward newer classes (integrase inhibitors and newer regimens) that reduce pill burden and improve tolerability.
• Patent/lifecycle dynamics and generic penetration in many markets since older antiretroviral agents entered off-patent status.

Who are the key competitors and how does that shape KALETRA pricing power?

Within HIV protease inhibitor space and broader HIV regimen selection, KALETRA competes indirectly with:

• Protease inhibitor alternatives (other boosted PIs in different formulations)
• Non-PI regimen classes that displace PI-based therapy where clinically appropriate

This competitive mix typically compresses:

• Net price realization
• Share of new starts
• Switching from PI-based regimens to preferred contemporary regimens

What does market projection look like for KALETRA (scenario framework)?

A projection requires quantified baseline estimates (current sales, units, geography split, generic vs branded share, and regional procurement forecasts). The prompt does not provide those inputs, and a complete, accurate projection cannot be generated without them.

What concrete metrics should be tracked for KALETRA over the next 2–5 years?

Even without a numeric projection, decision-grade monitoring for KALETRA should focus on observable leading indicators:

Uptake and displacement

• Share of new antiretroviral starts using PI-based regimens
• Switch rates from KALETRA to newer backbone regimens
• Formulary wins and losses in high-volume procurement markets

Pricing and reimbursement pressure

• Branded vs generic mix by geography
• Tender pricing trends for PI regimens
• Net-to-gross compression driven by competitive procurement cycles

Program-level demand stability

• Persistence on therapy (retention rate on PI regimens)
• Adherence metrics tied to dosing convenience and pill burden
• Resistance-guided use patterns (where PI continuation remains clinically justified)

Key takeaways

• KALETRA is in mature lifecycle conditions for HIV therapy, with demand mainly sustained by continuing PI use and formulary/tender inclusion rather than broad new-growth.
• Competitive dynamics and guideline shifts toward newer regimen classes structurally limit long-term expansion and typically favor share stabilization or decline rather than growth.
• A true “clinical trials update” and a numeric “market projection” require a trial inventory and current sales baselines; those are not present in the input.

FAQs

1. Is KALETRA still used in current HIV treatment guidelines?
   It remains a protease inhibitor option in certain regimens and scenarios, but it is generally not the default for new starts in regions with modern guideline-preferred regimens.

2. What drives KALETRA demand most today?
   Patient persistence on PI-based regimens, continued procurement/formulary inclusion, and use in specific clinical contexts where PI therapy remains appropriate.

3. What are the biggest headwinds for KALETRA?
   Ongoing displacement by newer antiretroviral classes, generic competition, and tender-driven price compression.

4. How should an investor model KALETRA’s near-term sales?
   By tracking formulary share, tender pricing, branded-to-generic mix, and switching rates away from PI-based backbones.

5. Are there still Phase 3 trials for KALETRA?
   New Phase 3 activity is generally limited for established older antiretrovirals; current activity often concentrates on label maintenance, special populations, or comparative regimen evaluations.

References

[1] AbbVie. KALETRA (lopinavir/ritonavir) prescribing information.
[2] U.S. FDA. Drug approval and labeling information for KALETRA (lopinavir/ritonavir).