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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR DIDANOSINE

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505(b)(2) Clinical Trials for DIDANOSINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

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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.
>Trial Type	>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

All Clinical Trials for DIDANOSINE

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000625 ↗	A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
NCT00000625 ↗	A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3	Completed	Glaxo Wellcome	Phase 2	1969-12-31	To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
NCT00000625 ↗	A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for DIDANOSINE

Condition Name

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Condition Name for DIDANOSINE
Intervention	Trials
HIV Infections	144
HIV Infection	4
HIV	3
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Condition MeSH

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Condition MeSH for DIDANOSINE
Intervention	Trials
HIV Infections	150
Acquired Immunodeficiency Syndrome	40
Infections	37
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Clinical Trial Locations for DIDANOSINE

Trials by Country

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Trials by Country for DIDANOSINE
Location	Trials
Puerto Rico	39
Thailand	28
Spain	23
Canada	14
South Africa	10
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Trials by US State

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Trials by US State for DIDANOSINE
Location	Trials
California	92
New York	75
Illinois	61
Florida	57
Massachusetts	54
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Clinical Trial Progress for DIDANOSINE

Clinical Trial Phase

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Clinical Trial Phase for DIDANOSINE
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	19
Phase 2/Phase 3	1
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Clinical Trial Status

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Clinical Trial Status for DIDANOSINE
Clinical Trial Phase	Trials
Completed	136
Unknown status	8
Terminated	6
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Clinical Trial Sponsors for DIDANOSINE

Sponsor Name

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Sponsor Name for DIDANOSINE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	81
Bristol-Myers Squibb	45
Glaxo Wellcome	18
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Sponsor Type

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Sponsor Type for DIDANOSINE
Sponsor	Trials
Industry	112
NIH	98
Other	42
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