INDINAVIR ANHYDROUS
Other / unclassified targets MMP2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | CRIXIVAN | — | 1998-02-06 – 2000-10-23 | fda.gov ↗ |
| Approved | EU (EMA) | Crixivan | — | 1996-10-04 | europa.eu ↗ |
| Approved | US (FDA) | CRIXIVAN | — | 1996-03-13 | fda.gov ↗ |
Trials 81 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT00002442 Background | Jun 1999 → ? | HIV infectious disease | Glaxo Wellcome | Completed | No outcome recorded |
| Phase 2 | NCT00001566 Background | Dec 1996 → Sep 2008 | Ewing sarcoma, rhabdomyosarcoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00002452 Background | — | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00001058 Background | ? → Jan 1999 | HIV infectious disease, Mycobacterium avium complex disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00000870 Background | ? → Mar 2007 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00000850 Background | ? → Dec 2003 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT00002371 Background | Jun 1996 → Dec 1997 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00000903 Background | ? → Jul 2001 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00002393 Background | — | HIV infectious disease | Dupont Merck | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02300623 Background | Mar 2000 → Apr 2013 | HIV infectious disease | Juan A. Arnaiz | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT00000923 Background | ? → Aug 2004 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000859 Background | ? → Dec 2001 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002401 Background | — | HIV infectious disease | Pharmacia and Upjohn | Completed | No outcome recorded |
| — | NCT00000875 Background | ? → Apr 2003 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| — | NCT00002369 Background | — | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 101 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | INDINAVIR ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Known as | Crixivan | “100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) +...” NCT00002369 ↗4“To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents.” NCT00002351 ↗ “Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗ “Crixivan (indinavir) plus Lexiva (fosamprenavir)” NCT00148785 ↗ “indinavir sulfate ( MK-639; Crixivan )” NCT00002155 ↗ |
| Known as | IDV | “The purpose of this study was to compare the pharmacokinetics, safety, and tolerability of indinavir (IDV)/RTV at 800/200 mg (arm A) and 400/400 mg (arm B) administered twice...” PMID 15483465 ↗ Nov 200427“Adult AIDS Clinical Trials Group 5043 examined pharmacokinetic (PK) interactions between amprenavir (APV) and efavirenz (EFV) both by themselves and when nelfinavir (NFV),...” PMID 16048950 ↗ Aug 2005 “The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the...” NCT00002241 ↗ “The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to...” NCT00000901 ↗ “This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC).” NCT00002424 ↗ “To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.” NCT00002443 ↗ “Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more.” NCT00000916 ↗ “The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.” NCT00002375 ↗ “All patients will receive open label induction therapy with zidovudine (ZDV), lamivudine (3TC) and indinavir (IDV) for 6 months.” NCT00001084 ↗ “The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice.” NCT00000922 ↗ “The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).” NCT00002401 ↗ “Arm A, B, C, and D: Patients receive indinavir (IDV), amprenavir (APV), ddI, and hydroxyurea (HU).” NCT00000919 ↗ “indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC)” NCT00002451 ↗ “This amendment substitutes indinavir (IDV) capsules for ritonavir capsules in PRAM-1.” NCT00001083 ↗ “Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV” NCT00012519 ↗ “The protease inhibitor provided on this study is indinavir (IDV).” NCT00000923 ↗ “delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV)” NCT00002236 ↗ “Arm B: APV plus indinavir (IDV) plus ABC plus EFV plus ADV.” NCT00000912 ↗ “indinavir (IDV), nevirapine (NVP), 3TC, and d4T” NCT00001095 ↗ “3TC/ZDV/indinavir (IDV) arm” NCT00002199 ↗ “1) indinavir (IDV) and RTV;” NCT00027339 ↗ “Indinavir (IDV) plus EFV.” NCT00000914 ↗ “indinavir (IDV)” NCT00001086 ↗ “indinavir (IDV)” NCT00006443 ↗ “Indinavir (IDV)” NCT00158405 ↗ “indinavir (IDV)” NCT00000896 ↗ “indinavir (IDV)” NCT00006397 ↗ “Indinavir (IDV)” NCT00000882 ↗ |
| Known as | Indinavir | “Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗91“Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents” NCT02556268 ↗ “Indinavir” NCT02300623 ↗ |
| Known as | Indinavir monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Known as | indinavir sulfate | “Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗6“MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks” NCT00541463 ↗ “indinavir sulfate (IDV)” NCT00039741 ↗ |
| Known as | Indinavir sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Known as | Indinavir system suitability | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Known as | indinavir/r | “The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.” NCT00122668 ↗ |
| Known as | Indinaviri sulfas | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Known as | L-735,524 | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Known as | MK-639 | “To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.” NCT00002443 ↗2“To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents.” NCT00002351 ↗ “indinavir sulfate ( MK-639; Crixivan )” NCT00002155 ↗ |
| Known as | MK0639 | “MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks” NCT00541463 ↗1“protease inhibitor indinavir (MK-0639)” NCT00001443 ↗ |
| Known as | NSC-697197 | ChEMBL registry synonym — accepted as the source's own label CHEMBL115 ↗ |
| Action | Inhibit | “which is an inhibitor of the HIV protease enzyme” NCT00000804 ↗ |
| Modality | Other / unclassified | “Protease Inhibitor” NCT00000919 ↗ |
| Route | Oral | “their oral administration is staggered” NCT00000877 ↗ |
| Target | MMP2 | “through a blockade of matrix metalloprotease 2 (MMP2) proteolytic activation.” NCT00362310 ↗ |