Drugs / Zalcitabine

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) HIVID 1994-08-05 – 1996-06-26 fda.gov
Approved US (FDA) HIVID 1992-06-19 fda.gov

Trials 34 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT00000902 ? → Apr 2002 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000954 ? → Sep 1996 HIV infectious disease, Kaposi's sarcoma National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000978 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000753 ? → Feb 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000704 ? → Apr 1990 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 212 trials
Phase 2 NCT00000679 ? → Feb 1994 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00001040 ? → May 1994 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 2 NCT00000781 ? → Sep 1996 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00001029 ? → May 1993 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00001032 ? → Apr 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00002333 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 2 NCT00000653 ? → Jun 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00002347 HIV infectious disease Parexel Completed No outcome recorded
Phase 2 NCT00002265 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 2 NCT00000625 ? → Nov 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00039741 Aug 2002 → Aug 2009 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 36 trials
Phase 3 NCT00002334 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00000651 ? → May 1993 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00002117 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00000682 ? → Sep 1992 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00001022 ? → Dec 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00002436 HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase 41 trial
Phase 4 NCT00002386 HIV infectious disease, hemophilia A Merck Sharp & Dohme LLC Completed No outcome recorded
Phase not applicable9 trials
NCT00000718 ? → Sep 1991 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT00002279 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
NCT00000969 ? → Sep 1992 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT00000719 ? → Feb 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT00002001 HIV infectious disease Glaxo Wellcome Completed No outcome recorded
NCT00000997 ? → Dec 1988 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
NCT00002256 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
NCT00002081 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
NCT00002118 HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT00032669 Background Mar 2002 → Apr 2006 HIV infectious disease National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00001035 Background ? → Sep 1996 HIV infectious disease, hepatitis C virus infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 24 trials
Phase 2 NCT00001048 Background ? → Apr 1997 HIV infectious disease, progressive multifocal leukoencephalopathy National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00000754 Background ? → Feb 1995 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00002162 Background HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 2 NCT00001087 Background ? → Jul 2000 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 31 trial
Phase 3 NCT00002109 Background HIV infectious disease Immunobiology Research Institute Completed No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as Zalcitabine “It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669
40

“tenofovir disoproxil fumarate (TDF), zalcitabine (ddC)” NCT00039741

NCT00000719

NCT00001048

NCT00002086

NCT00000753

NCT00000679

NCT00002117

NCT00002333

NCT00000625

NCT00000678

NCT00002436

NCT00000902

NCT00000704

NCT00002109

NCT00002386

NCT00001029

NCT00002334

NCT00002162

NCT00001022

NCT00002265

NCT00001040

NCT00000997

NCT00000954

NCT00000682

NCT00000969

NCT00002256

NCT00000718

NCT00002081

NCT00001032

NCT00001087

NCT00000978

NCT00000653

NCT00000651

NCT00000781

NCT00002001

NCT00002279

NCT00000754

NCT00001035

NCT00002118

NCT00002347

Known as 2',3'-dideoxycytidine “the drug 2',3'-dideoxycytidine ( zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ).” NCT00000704
1

“regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC )” NCT00000719

Known as ddC “To determine if alternating zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) (first one and then the other) or intermittent therapy (1 week of drug then 1 week off) will...” NCT00000718
28

“To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients...” NCT00000678

“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

“To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in...” NCT00000754

“To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC...” NCT00000679

“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

“To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.” NCT00002436

“interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC ) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E” NCT00000753

“Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ).” NCT00002347

“safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs” NCT00000978

“To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone” NCT00000651

“safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination” NCT00001032

“the drug 2',3'-dideoxycytidine ( zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ).” NCT00000704

“To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients with advanced HIV infection.” NCT00002081

“To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or advanced AIDS-related complex (ARC)” NCT00002279

“regimens of zidovudine ( AZT ) and 2',3'-dideoxycytidine ( zalcitabine; ddC )” NCT00000719

“zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable” NCT00002265

“zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours” NCT00000653

“when zalcitabine ( dideoxycytidine; ddC ) is given orally” NCT00000997

“tenofovir disoproxil fumarate (TDF), zalcitabine (ddC)” NCT00039741

“HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone” NCT00002333

“zalcitabine ( dideoxycytidine; ddC )” NCT00000969

“zalcitabine (dideoxycytidine; ddC)” NCT00001040

“Zalcitabine (Dideoxycytidine; ddC)” NCT00002334

“Zalcitabine (Dideoxycytidine; ddC)” NCT00002118

“zalcitabine (dideoxycytidine; ddC)” NCT00001029

“zalcitabine (dideoxycytidine; ddC)” NCT00000954

“AZT plus zalcitabine ( ddC )” NCT00000781

“zalcitabine (ddC)” NCT00002386

Known as Ddc (ddc) ChEMBL registry synonym — accepted as the source's own label CHEMBL853
Known as dideoxycytidine “To determine if alternating zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) (first one and then the other) or intermittent therapy (1 week of drug then 1 week off) will...” NCT00000718
19

“To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients...” NCT00000678

“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

“To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC...” NCT00000679

“To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.” NCT00002436

“interactive effects of didanosine ( ddI ) or zalcitabine ( dideoxycytidine; ddC ) with zidovudine ( AZT ) on the pharmacokinetics of U-87201E” NCT00000753

“To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone” NCT00000651

“safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination” NCT00001032

“To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients with advanced HIV infection.” NCT00002081

“To provide zalcitabine (dideoxycytidine; ddC) for patients with AIDS or advanced AIDS-related complex (ARC)” NCT00002279

“zalcitabine (dideoxycytidine; ddC) monotherapy is safe and tolerable” NCT00002265

“zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours” NCT00000653

“when zalcitabine ( dideoxycytidine; ddC ) is given orally” NCT00000997

“HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone” NCT00002333

“zalcitabine ( dideoxycytidine; ddC )” NCT00000969

“zalcitabine (dideoxycytidine; ddC)” NCT00000954

“Zalcitabine (Dideoxycytidine; ddC)” NCT00002118

“Zalcitabine (Dideoxycytidine; ddC)” NCT00002334

“zalcitabine (dideoxycytidine; ddC)” NCT00001040

“zalcitabine (dideoxycytidine; ddC)” NCT00001029

Known as HIVID HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone” NCT00002333
Known as NSC-606170 ChEMBL registry synonym — accepted as the source's own label CHEMBL853
Known as RO 24-2027/000 ChEMBL registry synonym — accepted as the source's own label CHEMBL853
Known as Zalcitabina ChEMBL registry synonym — accepted as the source's own label CHEMBL853
Known as Zalcitabine (dideoxycytidine,ddc) ChEMBL registry synonym — accepted as the source's own label CHEMBL853
Action Inhibit “AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators.” NCT00000754
Modality Small molecule “nucleoside analog” NCT00000781
Route Oral “taken orally every 8 hours” NCT00000653