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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR KALETRA

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Clinical Trials for Kaletra

Trial ID Title Status Sponsor Phase Summary
NCT00004578 ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects Completed Abbott Phase 1/Phase 2 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 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 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 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 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 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 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).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Kaletra

Condition Name

Condition Name for Kaletra
Intervention Trials
HIV Infections 66
HIV Infection 17
HIV 17
Human Immunodeficiency Virus 6
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Condition MeSH

Condition MeSH for Kaletra
Intervention Trials
HIV Infections 99
Acquired Immunodeficiency Syndrome 28
Immunologic Deficiency Syndromes 17
Infection 13
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Clinical Trial Locations for Kaletra

Trials by Country

Trials by Country for Kaletra
Location Trials
United States 265
Spain 61
Canada 35
Brazil 25
South Africa 22
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Trials by US State

Trials by US State for Kaletra
Location Trials
California 23
New York 18
Texas 17
Illinois 17
Florida 16
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Clinical Trial Progress for Kaletra

Clinical Trial Phase

Clinical Trial Phase for Kaletra
Clinical Trial Phase Trials
Phase 4 45
Phase 3 23
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Kaletra
Clinical Trial Phase Trials
Completed 97
Terminated 18
Unknown status 8
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Clinical Trial Sponsors for Kaletra

Sponsor Name

Sponsor Name for Kaletra
Sponsor Trials
Abbott 43
National Institute of Allergy and Infectious Diseases (NIAID) 13
Gilead Sciences 7
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Sponsor Type

Sponsor Type for Kaletra
Sponsor Trials
Other 119
Industry 87
NIH 27
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Healthtrust
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