Didanosine
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | VIDEX EC | — | 2002-01-29 – 2008-09-29 | fda.gov ↗ |
| Label expansions (7) | US (FDA) | VIDEX | — | 1992-09-25 – 2002-04-01 | fda.gov ↗ |
| Approved | US (FDA) | VIDEX | — | 1991-10-09 | fda.gov ↗ |
Trials 103 · started per year
Also used as a comparator or background therapy in 39 trials
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 147 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Didanosine | “It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗140“An Open Label, Randomised, Parallel Group Study of the Drug-drug Pharmacokinetic Interaction of Steady State Tipranavir (SEDDS SEC) 500 mg and Ritonavir (Soft Gelatin Capsules)...” NCT02251873 ↗ “Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ “A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine,...” NCT00214435 ↗ “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.” NCT01440569 ↗ “the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide” NCT00708162 ↗ “Second line regimen - ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir (Kaletra))” NCT00428116 ↗ “Didanosine (250 mg or 400 mg)” NCT01605084 ↗ “didanosine (ddI)” NCT02016924 ↗ “didanosine (ddI)” NCT06337032 ↗ |
| Known as | 2',3'-Dideoxyinosine | “A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related...” NCT00002028 ↗5“A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are...” NCT00000963 ↗ “An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000672 ↗ “Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients” NCT00002098 ↗ “Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine)” NCT00000656 ↗ “2',3'-Dideoxyinosine (ddI) (BMY-40900)” NCT00002035 ↗ |
| Known as | BMY-40900 | “An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000672 ↗1“2',3'-Dideoxyinosine (ddI) (BMY-40900)” NCT00002035 ↗ |
| Known as | ddI | “Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗94“Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1...” NCT00001066 ↗ “The purpose of this study is to make didanosine (ddI) available to children with AIDS who are clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter...” NCT00002280 ↗ “To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected...” NCT00001057 ↗ “Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the...” NCT00001022 ↗ “A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related...” NCT00002028 ↗ “The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir \[ABC\] plus efavirenz \[EFV\] plus...” NCT00005018 ↗ “To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are...” NCT00000839 ↗ “Double reverse transcriptase inhibitor (RTI) therapy consisting of any two therapy combinations of: didanosine (ddI), lamivudine (3TC), stavudine (d4T) or zidovudine (ZDV),...” NCT00002376 ↗ “Hydroxyurea, an agent broadly used for its antineoplastic properties, has been shown to inhibit HIV-1 in vitro and in vivo when combined with the nucleoside analogue reverse...” NCT00008866 ↗ “The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been...” PMID 18781872 ↗ Oct 2008 “A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are...” NCT00000963 ↗ “Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB...” NCT00398996 ↗ “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...” NCT00000625 ↗ “The nucleoside analogue combinations provided on this study are as follows: zidovudine (ZDV) plus didanosine (ddI), ZDV plus lamivudine (3TC), stavudine (d4T) plus 3TC, or d4T plus ddI.” NCT00000923 ↗ “To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected patients” NCT00001063 ↗ “Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV).” NCT00000919 ↗ “The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP).” NCT00001108 ↗ “NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.” NCT01440569 ↗ “To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI) administered in an alternating regimen in this patient population.” NCT00002313 ↗ “To determine whether there is a pharmacokinetic drug interaction between oral ganciclovir and oral zidovudine (AZT) and between oral ganciclovir and oral didanosine (ddI).” NCT00002096 ↗ “An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000672 ↗ “treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression” NCT00000637 ↗ “A Pilot Open Label Trial of HIV Therapy With d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects With Early Asymptomatic HIV Infection” NCT00002176 ↗ “Arm 1 (integrated arm) participants will receive didanosine (ddI), efavirenz (EFV), and lamivudine (3TC) once daily concurrent with standard TB therapy.” NCT00091936 ↗ “To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants.” NCT00001049 ↗ “Patients that are included are HIV infected and have started zidovudine (AZT) or didanosine (ddI) at least 4 weeks before entry into this study.” NCT00000971 ↗ “Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients” NCT00002098 ↗ “interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC ) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E” NCT00000753 ↗ “The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.” NCT00002412 ↗ “efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC)” PMID 20942650 ↗ Oct 2010 “Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults” NCT00002427 ↗ “Patients with CD4 counts 50-499 cells/mm3 receive didanosine (ddI) and are then randomized to receive ddI plus vaccine or control.” NCT00000822 ↗ “The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day” NCT00002207 ↗ “efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI)” NCT00000838 ↗ “nelfinavir (NFV) 30 mg/kg twice daily (bid), ritonavir (RTV) 400 mg/m bid and buffered didanosine (ddI) 240 mg/m daily (arm A)” PMID 16220085 ↗ Oct 2005 “To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection.” NCT00000652 ↗ “concurrent tipranavir (TPV) and ritonavir (RTV) administration on the single dose pharmacokinetics of didanosine (ddI)” NCT02251873 ↗ “An analysis is presented that promotes the use of uric acid levels as an indicator of patients didanosine (ddI) use.” PMID 8229656 ↗ Nov 1993 “The study-specified NRTIs will be abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T).” NCT00000922 ↗ “The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).” NCT00002211 ↗ “The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442.” NCT00002418 ↗ “ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\\^2 QD” NCT00364793 ↗ “Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.” NCT00002407 ↗ “A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.” NCT00000833 ↗ “low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone” NCT00000656 ↗ “Second line regimen - ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir (Kaletra))” NCT00428116 ↗ “Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine” NCT00001045 ↗ “Other medications which may be added include didanosine (ddI) and/or stavudine (d4T).” NCT00000916 ↗ “combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP)” NCT00002230 ↗ “Arm A receives stavudine (d4T) plus didanosine (ddI) plus ritonavir plus indinavir.” NCT00006339 ↗ “Antiretroviral Didanosine (ddI) : 240 mg/m\^2 up to a maximum of 400 mg once daily” NCT00016718 ↗ “compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT)” NCT00000671 ↗ “patients who have been taking didanosine (ddI) alone for a long time” NCT00000831 ↗ “zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination” NCT00000823 ↗ “didanosine (ddI) when administered both intravenously and orally” NCT00000710 ↗ “stavudine (d4T) alone and in combination with didanosine (ddI)” NCT00000851 ↗ “efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC)” NCT00116415 ↗ “ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir)” NCT00427297 ↗ “Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid” NCT00618176 ↗ “stavudine (d4T), didanosine (ddI), and BMS-232632” NCT00007202 ↗ “didanosine (ddI) plus AZT plus nevirapine (NVP);” NCT00000814 ↗ “either zidovudine ( AZT ) or didanosine ( ddI )” NCT00000810 ↗ “zidovudine ( AZT ) plus didanosine (ddI)” NCT00000781 ↗ “2',3'-Dideoxyinosine (ddI) (BMY-40900)” NCT00002035 ↗ “didanosine (ddI) plus stavudine (d4T)” NCT00001087 ↗ “Didanosine (ddI) is an anti-HIV drug.” NCT00002360 ↗ “orally administered didanosine (ddI)” NCT00000657 ↗ “enteric-coated didanosine (ddI)” NCT00109590 ↗ “standard-dose didanosine (ddI)” NCT00000772 ↗ “didanosine(ddI) monotherapy” PMID 15597521 ↗ Sep 2004 “2',3'-Dideoxyinosine; ddI” NCT00002099 ↗ “AZT plus didanosine (ddI)” NCT00001029 ↗ “Videx (Didanosine; ddI)” NCT00002234 ↗ “didanosine, ddI (drug)” NCT00196599 ↗ “didanosine, ddI (drug)” NCT00196612 ↗ “Didanosine ( ddI )” NCT00000803 ↗ “didanosine ( ddI )” NCT00000969 ↗ “didanosine (ddI)” NCT00002386 ↗ “didanosine (ddI)” NCT00002123 ↗ “didanosine (ddI)” NCT00000770 ↗ “didanosine (ddI)” NCT00005000 ↗ “didanosine (ddI)” NCT06337032 ↗ “Didanosine (ddI)” NCT00122538 ↗ “Didanosine (ddI)” NCT00000742 ↗ “didanosine (ddI)” NCT00000891 ↗ “ddI (Didanosine)” NCT00002177 ↗ “didanosine (ddI)” NCT00002420 ↗ “Didanosine (ddI)” NCT00142337 ↗ “Didanosine (ddI)” NCT00000865 ↗ “didanosine (ddI)” NCT02016924 ↗ “didanosine (ddI)” NCT00001122 ↗ “didanosine (ddI)” NCT00000982 ↗ “didanosine (ddI)” NCT00001997 ↗ |
| Known as | ddI-EC | “Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus...” NCT00014937 ↗2“enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632” NCT00007202 ↗ “This study tests a new form of didanosine, ddI EC, a coated pill” NCT00002429 ↗ |
| Known as | Ddl-EC | “Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC)” NCT00116415 ↗ |
| Known as | didanosine EC | “efavirenz; didanosine EC; lamivudine” NCT00116415 ↗ |
| Known as | Videx | “A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related...” NCT00002028 ↗3“Videx (Didanosine; ddI)” NCT00002234 ↗ “Videx (Didanosine)” NCT00002168 ↗ “Videx (Didanosine)” NCT00002420 ↗ |
| Action | Inhibit | “The drug ddI is an antiviral agent that inhibits replication of HIV with less apparent toxicity than AZT.” NCT00000671 ↗ |
| Modality | Small molecule | “nucleoside analog” NCT00000781 ↗ |
| Route | Oral | “orally administered didanosine (ddI)” NCT00000657 ↗ |