Drugs / INDINAVIR ANHYDROUS

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT00307502 Jan 2005 → Dec 2009 HIV infectious disease Germans Trias i Pujol Hospital Completed No outcome recorded
Phase 1 NCT00001644 Mar 1997 → Feb 2010 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00001443 Jul 1995 → Oct 2000 AIDS National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00000901 ? → Oct 2000 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00002351 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00001133 ? → Aug 2006 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000877 ? → Oct 2000 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00039975 ? → Apr 2004 HIV infectious disease, hypertensive disorder National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00002372 — HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase 1 NCT00000944 ? → Mar 2003 HIV infectious disease, pregnancy disorder National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT00411996 Dec 2006 → Oct 2008 HIV infectious disease, tuberculosis The HIV Netherlands Australia Thailand Research Collaboration Completed No outcome recorded
Phase 1/2 NCT00012519 ? → Jul 2005 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 228 trials · 1 met primary · 1 missed
Phase 2 NCT01067690 Jun 2008 → Oct 2015 Kaposi's sarcoma Barbara Ensoli, MD, PhD Completed No outcome recorded
Phase 2 NCT00637637 Sep 2007 → Jun 2009 cancer Oncology Institute of Southern Switzerland Unknown No outcome recorded
Phase 2 NCT00362310 Jun 2003 → Jul 2007 classic Kaposi sarcoma Italian National Institute of Health Completed No outcome recorded
Phase 2 NCT00120783 Feb 2002 → Aug 2003 HIV infectious disease French National Agency for Research on AIDS and Viral Hepatitis Terminated No outcome recorded
Phase 2 NCT00541463 Jan 2001 → May 2003 HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00002423 Mar 1999 → ? HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase 2 NCT00003008 Dec 1997 → Jun 2006 sarcoma Eastern Cooperative Oncology Group Completed No outcome recorded
Phase 2 NCT00001084 ? → Dec 1997 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00002361 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00002233 — HIV infectious disease Glaxo Wellcome 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 310 trials
Phase 3 NCT00158405 Dec 2002 → Dec 2006 HIV infectious disease French National Agency for Research on AIDS and Viral Hepatitis Completed Mixed
Phase 3 NCT00006397 Aug 2000 → ? HIV infectious disease PPD Development, LP Unknown No outcome recorded
Phase 3 NCT00002202 — HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase 3 NCT00006154 — HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00002199 — HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase 3 NCT00002406 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00000841 ? → Jun 1997 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00002220 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00002410 — HIV infectious disease Dupont Merck Completed No outcome recorded
Phase 3 NCT00002208 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 47 trials
Phase 4 NCT00148785 Jul 2005 → Jan 2007 HIV infectious disease Emory University Completed No outcome recorded
Phase 4 NCT00122668 Nov 2003 → Jul 2005 HIV infectious disease, lipodystrophy French National Agency for Research on AIDS and Viral Hepatitis Terminated No outcome recorded
Phase 4 NCT00192660 Feb 2003 → Oct 2006 cardiovascular disorder, lipodystrophy Kirby Institute Completed No outcome recorded
Phase 4 NCT00050180 Nov 2002 → Aug 2007 HIV infectious disease National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 4 NCT00002376 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 4 NCT00002179 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 4 NCT00002386 — HIV infectious disease, hemophilia A Merck Sharp & Dohme LLC Completed No outcome recorded
Phase not applicable23 trials · 1 missed
— NCT00122590 Jul 2002 → Mar 2005 HIV infectious disease French National Agency for Research on AIDS and Viral Hepatitis Terminated No outcome recorded
— NCT00016601 Jun 2001 → May 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00005762 Mar 2001 → May 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00006326 Aug 2000 → ? HIV infectious disease Agouron Pharmaceuticals Terminated No outcome recorded
— NCT00001119 Oct 1999 → Jun 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00002354 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
— NCT00002443 ? → Jan 1996 HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
— NCT00002155 — HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
— NCT00000896 ? → Oct 2000 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00006443 ? → Oct 2003 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Comparator or background therapy17 trials
Phase 1 NCT02556268 Background Feb → Dec 2016 — Bayer Completed No outcome recorded
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 NCT00000850 Background ? → Dec 2003 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) 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

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
1998-09-23 Gilead Sciences Results Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗
These data demonstrate that PREVEON has durable anti-HIV activity in treatment-experienced patients, including those infected with strains of HIV resistant to most currently approved therapies.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 101 sources stand behind the page.

FieldValueCited 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 2004
27

“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 ↗

Show 17 more sources

Known as Indinavir “Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents” NCT02556268 ↗
91

“Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗

“Indinavir” NCT02300623 ↗

NCT00002430 ↗

NCT00001083 ↗

NCT00002168 ↗

NCT00001644 ↗

NCT00362310 ↗

NCT00000901 ↗

NCT00541463 ↗

NCT00002179 ↗

Show 81 more sources

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 ↗

NCT00006154 ↗

NCT00002379 ↗

NCT00000870 ↗

NCT00002387 ↗

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-0639 “MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks” NCT00541463 ↗
1

“protease inhibitor indinavir (MK-0639)” NCT00001443 ↗

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 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 ↗