Drugs / Nelfinavir
last change Jun 2026 re-read 9 days ago

Nelfinavir

Other / unclassified

Developed for
HIV infectious disease · Kaposi's sarcoma · non-small cell lung carcinoma · plasma cell myeloma · cervical cancer · lung cancer · Mycobacterium avium complex disease · pancreatic adenocarcinoma
+33 more · pancreatic neoplasm · adult liposarcoma · cancer · Castleman disease · central nervous system neoplasm · cervical carcinoma · colorectal carcinoma · cutaneous melanoma · cytomegalovirus retinitis · dysplasia of cervix · Epstein-Barr virus infection · gastric cancer · glioblastoma · glioma · head and neck squamous cell carcinoma · hepatitis C virus infection · HIV-associated nephropathy · Hodgkins lymphoma · infectious disease with sepsis · leukemia · lymphoma · myelofibrosis · nasopharyngeal carcinoma · neoplasm of mature T-cells or NK-cells · non-Hodgkin lymphoma · ovarian serous cystadenocarcinoma · plasma cell neoplasm · prostate cancer · renal cell adenocarcinoma · renal cell carcinoma · salivary gland adenoid cystic carcinoma · systemic lupus erythematosus · vulva cancer
Investigated by
National Institute of Allergy and Infectious Diseases (NIAID) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · National Cancer Institute (NCI) · Agouron Pharmaceuticals · Glaxo Wellcome · Abramson Cancer Center at Penn Medicine
+56 more · Hoffmann-La Roche · Bristol-Myers Squibb · Mayo Clinic · Merck Sharp & Dohme LLC · Pfizer · Swiss Cancer Institute · University of Iowa · Abbott · Boehringer Ingelheim · Centers for Disease Control and Prevention · Gilead Sciences · Holden Comprehensive Cancer Center · Maastricht Radiation Oncology · Medical University of South Carolina · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Nebraska · AIDS Associated Malignancies Clinical Trials Consortium · AIDS Malignancy Consortium · AIDS and Cancer Specimen Resource · Academic Medical Center - University of Amsterdam · Cancer Research UK · Celgene Corporation · City of Hope Medical Center · Dartmouth-Hitchcock Medical Center · Eastern Cooperative Oncology Group · Fight AIDS and Infectious Diseases Foundation · French National Agency for Research on AIDS and Viral Hepatitis · Germans Trias i Pujol Hospital · Jasper Clinic, Michigan · Kirby Institute · M.D. Anderson Cancer Center · Maastricht University Medical Center · Montefiore Medical Center · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Mental Health (NIMH) · National Institutes of Health (NIH) · Northwell Health · Oxford University Hospitals NHS Trust · PENTA Foundation · Pharmacia and Upjohn · St Vincent's Hospital, Sydney · Tata Memorial Hospital · The Emmes Company, LLC · The University of Texas Health Science Center, Houston · US Department of Veterans Affairs · University of Arkansas · University of California, Irvine · University of California, Los Angeles · University of California, San Diego · University of Maryland, Baltimore · University of Miami · University of Oxford · University of Washington · University of Wisconsin, Madison

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Viracept — 2013-01-23 europa.eu ↗
Label expansions (3) US (FDA) VIRACEPT — 1999-11-24 – 2004-03-19 fda.gov ↗
Approved EU (EMA) Viracept — 1998-01-22 europa.eu ↗
Approved US (FDA) VIRACEPT — 1997-03-14 fda.gov ↗

Trials 119 · started per year

today
US approved 1997
EU approved 1998
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1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02080416 Jul 2014 → Feb 2016 Castleman disease, Epstein-Barr virus infection, Hodgkins lymphoma, Kaposi's sarcoma +3 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded Stop: Enrollment
Phase 133 trials
Phase 1 NCT04169763 Aug 2020 → Dec 2026 expected vulva cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT03829020 Apr 2019 → Sep 2022 plasma cell myeloma Mayo Clinic Completed No outcome recorded
Phase 1 NCT03422874 Aug 2016 → Aug 2017 lymphoma Dartmouth-Hitchcock Medical Center Withdrawn No outcome recorded
Phase 1 NCT02363829 Feb 2015 → Feb 2020 cervical carcinoma Abramson Cancer Center at Penn Medicine Completed No outcome recorded
Phase 1 NCT01485731 Jan 2012 → Feb 2015 cervical cancer University of Miami Completed No outcome recorded
Phase 1 NCT01164709 Jul 2010 → Jul 2012 leukemia, neoplasm of mature T-cells or NK-cells, plasma cell neoplasm Swiss Cancer Institute Completed No outcome recorded
Phase 1 NCT01079286 Jun 2009 → May 2011 renal cell carcinoma Academic Medical Center - University of Amsterdam Completed No outcome recorded
Phase 1 NCT01086332 May 2009 → Jul 2011 pancreatic neoplasm University of Iowa Terminated No outcome recorded Stop: Business
Phase 1 NCT00915694 Apr 2009 → Jul 2011 central nervous system neoplasm Abramson Cancer Center at Penn Medicine Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT01020292 Apr 2009 → Dec 2017 glioma Abramson Cancer Center at Penn Medicine Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT07281781 Sep 2025 → Jun 2026 overdue myelofibrosis University of California, Irvine Recruiting No outcome recorded
Phase 1/2 NCT05036226 Mar 2022 → May 2027 expected prostate cancer Medical University of South Carolina Recruiting No outcome recorded
Phase 1/2 NCT02024009 Mar 2016 → Jun 2021 pancreatic neoplasm University of Oxford Completed No outcome recorded
Phase 1/2 NCT01555281 Feb 2012 → Jun 2022 plasma cell myeloma Swiss Cancer Institute Terminated No outcome recorded
Phase 1/2 NCT01447589 Feb → Oct 2012 lung cancer Oxford University Hospitals NHS Trust Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT00704600 Sep 2008 → Sep 2010 colorectal carcinoma Maastricht Radiation Oncology Completed No outcome recorded
Phase 1/2 NCT00589056 Jun 2007 → Mar 2012 lung cancer Abramson Cancer Center at Penn Medicine Completed No outcome recorded
Phase 1/2 NCT00233948 Mar 2006 → Jul 2013 adult liposarcoma City of Hope Medical Center Terminated No outcome recorded
Phase 232 trials · 1 missed
Phase 2 NCT06971744 Dec 2025 → Jun 2028 expected ovarian serous cystadenocarcinoma Medical University of South Carolina Recruiting No outcome recorded
Phase 2 NCT01925378 Nov 2018 → Dec 2022 dysplasia of cervix The University of Texas Health Science Center, Houston Withdrawn No outcome recorded
Phase 2 NCT03050060 Jun 2017 → Oct 2018 cutaneous melanoma, non-small cell lung carcinoma, renal cell adenocarcinoma University of Washington Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03077451 Mar 2017 → May 2022 Kaposi's sarcoma AIDS Malignancy Consortium Completed No outcome recorded
Phase 2 NCT02188537 Dec 2014 → Jul 2016 plasma cell myeloma Swiss Cancer Institute Completed No outcome recorded
Phase 2 NCT02066311 Sep 2014 → Jun 2018 systemic lupus erythematosus Northwell Health Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02207439 Jul 2014 → May 2021 head and neck squamous cell carcinoma Abramson Cancer Center at Penn Medicine Completed No outcome recorded
Phase 2 NCT01728779 Jan 2014 → Mar 2020 — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 2 NCT01959672 Sep 2013 → Apr 2018 pancreatic adenocarcinoma University of Nebraska Completed No outcome recorded
Phase 2 NCT01108666 Mar 2010 → Jul 2018 non-small cell lung carcinoma Abramson Cancer Center at Penn Medicine Terminated No outcome recorded Stop: Enrollment
Phase 2/32 trials · 2 missed
Phase 2/3 NCT00624195 Mar 2007 → Feb 2012 HIV infectious disease University of California, San Diego Completed Missed primary
Phase 2/3 NCT00039741 Aug 2002 → Aug 2009 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 313 trials · 1 missed
Phase 3 NCT03256916 Jan 2018 → May 2024 cervical cancer Tata Memorial Hospital Completed No outcome recorded
Phase 3 NCT00099359 Feb 2004 → Feb 2011 HIV infectious disease Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Completed No outcome recorded
Phase 3 NCT00017719 May 2002 → Mar 2006 HIV infectious disease, pregnancy disorder National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 3 NCT00028067 Aug 2001 → Apr 2002 HIV infectious disease Bristol-Myers Squibb Terminated No outcome recorded
Phase 3 NCT00009061 Nov 2000 → ? HIV infectious disease Glaxo Wellcome Unknown No outcome recorded
Phase 3 NCT00008554 Nov 2000 → ? HIV infectious disease Glaxo Wellcome Unknown No outcome recorded
Phase 3 NCT00004583 Mar 1999 → ? HIV infectious disease Abbott Completed No outcome recorded
Phase 3 NCT00028327 ? → Jul 2004 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00002178 — HIV infectious disease Hoffmann-La Roche Completed No outcome recorded
Phase 3 NCT00002397 — HIV infectious disease, HIV-associated nephropathy Hoffmann-La Roche Completed No outcome recorded
Phase 49 trials
Phase 4 NCT00246610 Mar 2006 → Nov 2007 HIV infectious disease Pfizer Completed No outcome recorded
Phase 4 NCT00312182 Mar → Jun 2006 — Pfizer Completed No outcome recorded
Phase 4 NCT00251030 Nov 2005 → Jan 2006 — Pfizer Completed No outcome recorded
Phase 4 NCT00141284 Oct 2005 → Dec 2006 HIV infectious disease, hepatitis C virus infection Pfizer Completed No outcome recorded
Phase 4 NCT00192660 Feb 2003 → Oct 2006 cardiovascular disorder, lipodystrophy Kirby Institute Completed No outcome recorded
Phase 4 NCT00006190 Nov 2000 → Nov 2001 HIV infectious disease, lipodystrophy National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed No outcome recorded
Phase 4 NCT00023400 Feb 2000 → Feb 2002 HIV infectious disease, tuberculosis Centers for Disease Control and Prevention Completed No outcome recorded
Phase 4 NCT00005000 Dec 1999 → ? HIV infectious disease Agouron Pharmaceuticals Unknown No outcome recorded
Phase 4 NCT00005106 Sep 1999 → ? HIV infectious disease Glaxo Wellcome Completed No outcome recorded
Phase not applicable21 trials · 2 missed
— NCT00205283 Aug 2003 → Aug 2005 HIV infectious disease University of Wisconsin, Madison Completed No outcome recorded
— 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
— NCT00002411 Mar 1998 → Sep 1999 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
— NCT00002176 May 1997 → Mar 2000 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
— NCT00002177 May 1997 → Mar 2000 HIV infectious disease Bristol-Myers Squibb Completed No outcome recorded
— NCT00002201 — HIV infectious disease Abbott Completed No outcome recorded
— NCT00000892 ? → Aug 1999 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00000922 ? → Jan 2003 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Comparator or background therapy16 trials
Phase 1 NCT00000899 Background ? → Oct 2001 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT00006211 Background Feb 2000 → Apr 2001 HIV infectious disease Agouron Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00004985 Background Jan 2000 → ? HIV infectious disease Agouron Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00004998 Background Nov 1999 → ? HIV infectious disease Agouron Pharmaceuticals Suspended No outcome recorded
Phase 2 NCT00004999 Background Aug 1999 → ? HIV infectious disease Agouron Pharmaceuticals Suspended No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2004-01-20 Vertex Pharmaceuticals Incorporated Results Phase III, 48-Week NEAT Study Results Comparing LEXIVA(TM) to Nelfinavir Published in the Journal of Acquired Immune Deficiency Syndrome (JAIDS) vrtx.com ↗
In the trial, 66 percent of 166 HIV+ patients (n=109) achieved a viral load (vRNA) 400 copies/mL with LEXIVA, compared to 51 percent of 83 patients (n=42) taking nelfinavir.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 142 sources stand behind the page.

FieldValueCited text
Known as nelfinavir “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗
126

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

“receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician.” NCT00000895 ↗

“The HIV protease inhibitor nelfinavir (NFV) displays notable radiosensitizing effects.” PMID 30825970 ↗ Dec 2018

“nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately” NCT00001087 ↗

“nelfinavir (NLV)” NCT00336778 ↗

“nelfinavir NFV)” NCT03631732 ↗

NCT00016601 ↗

NCT00002184 ↗

NCT06971744 ↗

NCT00002177 ↗

Show 116 more sources

Known as A430 “A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With...” NCT00141284 ↗
Known as AG-1343 ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗
Known as Nelfinavir mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗
Known as Nelfinavir mesylate “The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective...” NCT00006211 ↗
20

“This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and...” NCT06971744 ↗

“Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗

“VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV) protease.” NCT02024009 ↗

“To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients” NCT00002165 ↗

“Nelfinavir mesylate (Viracept) is an inhibitor of the HIV protease 1.” NCT01555281 ↗

“Viracept (Nelfinavir Mesylate)” NCT00004999 ↗

“Drug: Nelfinavir Mesylate” NCT03077451 ↗

“nelfinavir mesylate (NFV)” NCT00039741 ↗

“Nelfinavir mesylate” NCT00002201 ↗

“Nelfinavir mesylate” NCT00000887 ↗

Show 10 more sources

Known as Nelfinavir methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗
Known as Nelfinaviri mesilas ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗
Known as NEV “receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician.” NCT00000895 ↗
Known as NFV “The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group...” NCT00205283 ↗
35

“Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and...” NCT02363829 ↗

“This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and...” NCT06971744 ↗

“This is a phase 2 trial of the HIV protease inhibitor (HPI) Nelfinavir (NFV) in combination with radiotherapy and chemotherapy in patients with locally advanced non-small cell...” NCT00791336 ↗

“In Pediatric AIDS Clinical Trials Group 377, antiretroviral therapy-experienced children were randomized to 4 treatment arms that included different combinations of stavudine,...” PMID 11372025 ↗ May 2001

“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

“Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors (stavudine, lamivudine, zidovudine, didanosine, zalcitabine) plus...” NCT00000902 ↗

“either nelfinavir (NFV) 30 mg/kg twice daily (bid), ritonavir (RTV) 400 mg/m bid and buffered didanosine (ddI) 240 mg/m daily (arm A) or NFV 50-55 mg/kg bid, nevirapine (NVP)...” PMID 16220085 ↗ Oct 2005

“Nelfinavir (NFV), an FDA-approved protease inhibitor for the treatment of HIV, has been shown to be a potent activator of lytic gene expression of EBV(+) and KSHV(+) cancer cell lines.” NCT02080416 ↗

“Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV).” NCT00000919 ↗

“The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP).” NCT00001108 ↗

Show 25 more sources

Known as NLF “The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).” NCT00002211 ↗
1

“Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).” NCT00002224 ↗

Known as NLV “nelfinavir (NLV)” NCT00336778 ↗
Known as NSC-747167 ChEMBL registry synonym — accepted as the source's own label CHEMBL584 ↗
Known as Viracept “A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With...” NCT00141284 ↗
10

“The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective...” NCT00006211 ↗

“An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (Viramune) and Nelfinavir (Viracept) and the Efficacy of This Combination Therapy in HIV-1...” NCT00002381 ↗

“A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Nelfinavir (Viracept) Co-Administered With Zidovudine (ZDV) and Lamivudine (3TC) in HIV Infected Pregnant...” NCT00000887 ↗

“Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h” NCT00002235 ↗

“These patients are eligible to receive funding for up to a 3-month supply of nelfinavir (Viracept) and Combivir.” NCT00005002 ↗

“To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients” NCT00002165 ↗

“Viracept (Nelfinavir Mesylate)” NCT00004999 ↗

“Nelfinavir (Viracept®) 1250 mg” NCT02207439 ↗

“nelfinavir (Viracept)” NCT00002215 ↗

“Viracept (nelfinavir)” NCT00004998 ↗

Action Inhibit “other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir)” NCT00000892 ↗
Modality Other / unclassified “Protease Inhibitor” NCT00000919 ↗
Route Oral “Oral Nelfinavir” NCT00000887 ↗