Drugs / Delavirdine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) RESCRIPTOR — 2001-05-16 fda.gov ↗
Approved US (FDA) RESCRIPTOR — 1997-04-04 fda.gov ↗

Trials 19

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00000810 ? → Jan 1996 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 26 trials
Phase 2 NCT00000882 ? → May 1999 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00000891 ? → May 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00000803 ? → Mar 1997 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00001094 — HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded
Phase 2 NCT00002210 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Phase 2 NCT00002420 — HIV infectious disease Bristol-Myers Squibb Terminated No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3 NCT00624195 Mar 2007 → Feb 2012 HIV infectious disease University of California, San Diego Completed Missed primary
Phase 34 trials
Phase 3 NCT00002124 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Phase 3 NCT00002178 — HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00002378 — HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00002123 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Phase not applicable7 trials
— NCT00006326 Aug 2000 → ? HIV infectious disease Agouron Pharmaceuticals Terminated No outcome recorded
— NCT00002400 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
— NCT00002401 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
— NCT00002312 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
— NCT00002236 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
— NCT00000892 ? → Aug 1999 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00002211 — HIV infectious disease Pharmacia and Upjohn Completed No outcome recorded
Comparator or background therapy2 trials
Phase 2 NCT02249130 Background Mar 1999 → Apr 2000 HIV infectious disease Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT03631732 Comparator Aug 2018 → Aug 2019 HIV infectious disease Gilead Sciences Completed Met primary

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as Delavirdine “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗
19

“delavirdine (DLV)” NCT03631732 ↗

NCT00002124 ↗

NCT00000882 ↗

NCT00002400 ↗

NCT00002211 ↗

NCT00000803 ↗

NCT02249130 ↗

NCT00001094 ↗

NCT00002401 ↗

NCT00002236 ↗

Show 9 more sources

Known as Delavirdina ChEMBL registry synonym — accepted as the source's own label CHEMBL593 ↗
Known as Delavirdine mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL593 ↗
Known as Delavirdine mesylate “The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to...” NCT00002210 ↗
3

“Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)” NCT00000810 ↗

“Delavirdine mesylate ( U-90152 )” NCT00000803 ↗

NCT00002378 ↗

Known as Delavirdine methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL593 ↗
Known as DLV “An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens...” NCT00002211 ↗
11

“Zidovudine (ZDV), lamivudine (3TC), stavudine (d4T), didanosine (ddI), delavirdine (DLV), ritonavir (RTV), and saquinavir soft gel capsules (SQV sgc) are provided on-study.” NCT00000891 ↗

“The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients.” NCT00002401 ↗

“Arm A: Saquinavir (SQV) plus ritonavir (RTV) plus delavirdine (DLV) plus adefovir dipivoxil placebo.” NCT00000892 ↗

“delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV)” NCT00002236 ↗

“Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)” NCT00000810 ↗

“delavirdine mesylate (DLV)” NCT00002124 ↗

“delavirdine (DLV)” NCT00001094 ↗

“Delavirdine (DLV)” NCT00000882 ↗

“delavirdine (DLV)” NCT00002420 ↗

“delavirdine (DLV)” NCT03631732 ↗

Show 1 more source

Known as Rescriptor “An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens...” NCT00002211 ↗
3

“The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to...” NCT00002210 ↗

“An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in...” NCT00002401 ↗

“Rescriptor (Delavirdine Mesylate)” NCT00002420 ↗

Known as U-90152 “To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 ) after multiple doses given orally to asymptomatic HIV-1 positive patients who are...” NCT00002312 ↗
2

“delavirdine mesylate ( U-90152 ) monotherapy” NCT00000810 ↗

“Delavirdine mesylate ( U-90152 )” NCT00000803 ↗

Known as U-90152S “Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)” NCT00000810 ↗
2

“Delavirdine Mesylate (U-90152S)” NCT00002123 ↗

“Delavirdine Mesylate (U-90152S)” NCT00002124 ↗

Known as U-90152T ChEMBL registry synonym — accepted as the source's own label CHEMBL593 ↗
Action Inhibit “nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV” NCT00000882 ↗
Modality Small molecule “bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents” NCT00000810 ↗
Route Oral “multiple doses given orally” NCT00002312 ↗