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Last Updated: January 27, 2022

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CLINICAL TRIALS PROFILE FOR SUSTIVA

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505(b)(2) Clinical Trials for Sustiva

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 NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Bristol-Myers Squibb Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Dupont Applied Biosciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Glaxo Wellcome Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Gilead Sciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sustiva

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001758 ↗ Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1997-11-01 This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen). HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome
NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Bristol-Myers Squibb Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Dupont Applied Biosciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Glaxo Wellcome Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Gilead Sciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002235 ↗ A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors Completed Agouron Pharmaceuticals Phase 2 1969-12-31 Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sustiva

Condition Name

Condition Name for Sustiva
Intervention Trials
HIV Infections 36
HIV 11
HIV Infection 8
Healthy 5
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Condition MeSH

Condition MeSH for Sustiva
Intervention Trials
HIV Infections 47
Infections 9
Acquired Immunodeficiency Syndrome 9
Infection 8
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Clinical Trial Locations for Sustiva

Trials by Country

Trials by Country for Sustiva
Location Trials
United States 145
Spain 29
Canada 8
South Africa 6
Puerto Rico 6
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Trials by US State

Trials by US State for Sustiva
Location Trials
California 18
New York 11
District of Columbia 10
Texas 9
Florida 8
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Clinical Trial Progress for Sustiva

Clinical Trial Phase

Clinical Trial Phase for Sustiva
Clinical Trial Phase Trials
Phase 4 19
Phase 3 7
Phase 2/Phase 3 1
[disabled in preview] 32
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Clinical Trial Status

Clinical Trial Status for Sustiva
Clinical Trial Phase Trials
Completed 55
Unknown status 4
Terminated 3
[disabled in preview] 5
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Clinical Trial Sponsors for Sustiva

Sponsor Name

Sponsor Name for Sustiva
Sponsor Trials
Bristol-Myers Squibb 8
National Institute of Allergy and Infectious Diseases (NIAID) 6
Abbott 5
[disabled in preview] 11
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Sponsor Type

Sponsor Type for Sustiva
Sponsor Trials
Other 76
Industry 44
NIH 15
[disabled in preview] 1
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Serving leading biopharmaceutical companies globally:

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Medtronic
Harvard Business School

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