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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR DIDANOSINE

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Clinical Trials for Didanosine

Trial ID Title Status Sponsor Phase 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 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 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 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 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.
NCT00000637 A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children Completed Glaxo Wellcome Phase 3 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.
NCT00000637 A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 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.
NCT00000652 A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection Completed National Cancer Institute (NCI) Phase 1 To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection. New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Didanosine

Condition Name

Condition Name for Didanosine
Intervention Trials
HIV Infections 135
HIV Infection 3
HIV 3
AIDS 3
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Condition MeSH

Condition MeSH for Didanosine
Intervention Trials
HIV Infections 139
Acquired Immunodeficiency Syndrome 36
Infection 32
Communicable Diseases 16
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Clinical Trial Locations for Didanosine

Trials by Country

Trials by Country for Didanosine
Location Trials
Puerto Rico 36
Thailand 27
Spain 16
Canada 10
South Africa 9
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Trials by US State

Trials by US State for Didanosine
Location Trials
California 88
New York 71
Illinois 57
Florida 53
North Carolina 49
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Clinical Trial Progress for Didanosine

Clinical Trial Phase

Clinical Trial Phase for Didanosine
Clinical Trial Phase Trials
Phase 4 12
Phase 3 15
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Didanosine
Clinical Trial Phase Trials
Completed 125
Unknown status 7
Terminated 5
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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) 75
Bristol-Myers Squibb 44
Glaxo Wellcome 17
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Sponsor Type

Sponsor Type for Didanosine
Sponsor Trials
Industry 109
NIH 89
Other 34
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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Julphar
Argus Health
Express Scripts
Mallinckrodt
Chinese Patent Office
Johnson and Johnson
Cerilliant
Baxter

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