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Last Updated: November 26, 2022

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
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 Didanosine

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.
NCT00000637 ↗ A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children Completed Bristol-Myers Squibb Phase 3 1969-12-31 To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Didanosine

Condition Name

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

Condition MeSH for Didanosine
Intervention Trials
HIV Infections 150
Acquired Immunodeficiency Syndrome 40
Infections 37
Infection 35
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Clinical Trial Locations for Didanosine

Trials by Country

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

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

Clinical Trial Phase for Didanosine
Clinical Trial Phase Trials
Phase 4 13
Phase 3 19
Phase 2/Phase 3 1
[disabled in preview] 55
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Clinical Trial Status

Clinical Trial Status for Didanosine
Clinical Trial Phase Trials
Completed 136
Unknown status 8
Terminated 6
[disabled in preview] 4
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Clinical Trial Sponsors for Didanosine

Sponsor Name

Sponsor Name for Didanosine
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 81
Bristol-Myers Squibb 45
Glaxo Wellcome 18
[disabled in preview] 8
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Sponsor Type

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