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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR LOPINAVIR AND RITONAVIR

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505(b)(2) Clinical Trials for Lopinavir And 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lopinavir And Ritonavir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004578 ↗ ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Na├»ve 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.
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.
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.
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.
NCT00027339 ↗ Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient's current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient's response to anti-HIV therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lopinavir And Ritonavir

Condition Name

Condition Name for Lopinavir And Ritonavir
Intervention Trials
HIV Infections 136
HIV 34
COVID-19 33
HIV Infection 31
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Condition MeSH

Condition MeSH for Lopinavir And Ritonavir
Intervention Trials
HIV Infections 190
Acquired Immunodeficiency Syndrome 40
Infection 29
Immunologic Deficiency Syndromes 25
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Clinical Trial Locations for Lopinavir And Ritonavir

Trials by Country

Trials by Country for Lopinavir And Ritonavir
Location Trials
United States 714
Spain 84
Thailand 61
Canada 56
South Africa 48
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Trials by US State

Trials by US State for Lopinavir And Ritonavir
Location Trials
California 58
New York 51
Florida 39
Texas 38
Illinois 37
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Clinical Trial Progress for Lopinavir And Ritonavir

Clinical Trial Phase

Clinical Trial Phase for Lopinavir And Ritonavir
Clinical Trial Phase Trials
Phase 4 92
Phase 3 74
Phase 2/Phase 3 24
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Clinical Trial Status

Clinical Trial Status for Lopinavir And Ritonavir
Clinical Trial Phase Trials
Completed 185
Not yet recruiting 47
Recruiting 33
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Clinical Trial Sponsors for Lopinavir And Ritonavir

Sponsor Name

Sponsor Name for Lopinavir And Ritonavir
Sponsor Trials
Abbott 55
National Institute of Allergy and Infectious Diseases (NIAID) 45
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 17
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Sponsor Type

Sponsor Type for Lopinavir And Ritonavir
Sponsor Trials
Other 452
Industry 141
NIH 75
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