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Last Updated: September 21, 2021

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CLINICAL TRIALS PROFILE FOR AMPRENAVIR

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505(b)(2) Clinical Trials for Amprenavir

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 Amprenavir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000903 ↗ Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV alone, in the treatment of patients with advanced HIV disease who have received limited or no prior antiretroviral therapy. Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, immunological, and virological results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will also be evaluated as an addition to IDV/ZDV/3TC.
NCT00000912 ↗ A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.
NCT00000918 ↗ A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment. In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amprenavir

Condition Name

Condition Name for Amprenavir
Intervention Trials
HIV Infections 45
HIV Infection 5
Healthy 5
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Condition MeSH

Condition MeSH for Amprenavir
Intervention Trials
HIV Infections 54
Infection 15
Acquired Immunodeficiency Syndrome 13
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Clinical Trial Locations for Amprenavir

Trials by Country

Trials by Country for Amprenavir
Location Trials
United States 355
Canada 12
Puerto Rico 9
Brazil 5
France 5
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Trials by US State

Trials by US State for Amprenavir
Location Trials
New York 29
California 29
North Carolina 23
Florida 21
Pennsylvania 17
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Clinical Trial Progress for Amprenavir

Clinical Trial Phase

Clinical Trial Phase for Amprenavir
Clinical Trial Phase Trials
Phase 4 6
Phase 3 7
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Amprenavir
Clinical Trial Phase Trials
Completed 57
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for Amprenavir

Sponsor Name

Sponsor Name for Amprenavir
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 20
Glaxo Wellcome 18
GlaxoSmithKline 10
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Sponsor Type

Sponsor Type for Amprenavir
Sponsor Trials
Industry 46
NIH 25
Other 18
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