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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT00000704 ? → Apr 1990 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 NCT00000902 ? → Apr 2002 HIV infectious disease 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 NCT00000954 ? → Sep 1996 HIV infectious disease, Kaposi's sarcoma National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 212 trials
Phase 2 NCT00000781 ? → Sep 1996 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 NCT00000679 ? → Feb 1994 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 NCT00000625 ? → Nov 1995 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 NCT00002086 — HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase 2 NCT00000678 ? → Jul 1992 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3 NCT00039741 Aug 2002 → Aug 2009 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 36 trials
Phase 3 NCT00002117 — HIV infectious disease Hoffmann-La Roche 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 3 NCT00000682 ? → Sep 1992 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
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 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
— NCT00000997 ? → Dec 1988 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
— NCT00000719 ? → Feb 1995 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
— NCT00002118 — HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
— NCT00002081 — 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
— NCT00002256 — HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Comparator or background therapy7 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 2 NCT00001087 Background ? → Jul 2000 HIV infectious disease 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

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 ↗

NCT00000754 ↗

NCT00002001 ↗

NCT00000625 ↗

NCT00002256 ↗

NCT00000651 ↗

NCT00002334 ↗

NCT00002118 ↗

NCT00002117 ↗

NCT00002347 ↗

Show 30 more sources

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 ↗

Show 18 more sources

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 ↗

Show 9 more sources

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 ↗