Clinical Trials

Nelfinavir mesylate has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, primarily for HIV infections, co-occurring conditions, and various solid tumors including cervical, colorectal, and lung cancers. Supported by government agencies, academic institutions, and pharmaceutical entities, these studies have investigated combination regimens and radiosensitizing properties. Although many protocols are completed, the overall trial record includes recruiting, suspended, terminated, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06971744 RECRUITING
Ovarian Cancer
Medical University of South Carolina
 2025-12-18 PHASE2
NCT05036226 RECRUITING
Prostate Cancer Recurrent; Solid Tumor, Adult
Medical University of South Carolina
 2022-03-03 PHASE1; PHASE2
NCT04169763 RECRUITING
Stage II Vulvar Cancer AJCC v8; Stage III Vulvar Cancer AJCC v8; Stage IIIA Vulvar Cancer AJCC v8; Stage IIIB Vulvar Cancer AJCC v8; Stage IIIC Vulvar Cancer AJCC v8; Stage IVA Vulvar Cancer AJCC v8
M.D. Anderson Cancer Center
 2020-08-07 PHASE1
NCT07281781 RECRUITING
Myelofibrosis; Myelofibrosis; Anemia
University of California, Irvine
 2025-09-16 PHASE1; PHASE2
NCT03256916 COMPLETED
Carcinoma Cervix,Stage III
Tata Memorial Hospital
 2018-01-16 PHASE3
NCT01925378 WITHDRAWN
Cervical Dysplasia
The University of Texas Health Science Center, Houston
 2018-11-07 PHASE2
NCT03829020 COMPLETED
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
Mayo Clinic
 2019-04-17 PHASE1
NCT01555281 TERMINATED
Multiple Myeloma
Swiss Cancer Institute
 2012-02-23 PHASE1; PHASE2
NCT03077451 COMPLETED
Recurrent Kaposi Sarcoma; Skin Kaposi Sarcoma
AIDS Malignancy Consortium
 2017-03-13 PHASE2
NCT02024009 COMPLETED
Pancreatic Neoplasms (Locally Advanced Non-metastatic)
University of Oxford
 2016-03 PHASE1; PHASE2
NCT02207439 COMPLETED
Head and Neck Squamous Cell Carcinoma
Abramson Cancer Center at Penn Medicine
 2014-07 PHASE2
NCT01728779 COMPLETED
Oligometastases
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2014-01-08 PHASE2
NCT02363829 COMPLETED
Uterine Cervix Cancer
Abramson Cancer Center at Penn Medicine
 2015-02 PHASE1
NCT03050060 TERMINATED
Metastatic Kidney Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Cutaneous Melanoma AJCC v6 and v7; Stage IV Renal Cell Cancer AJCC v7; Stage IV Lung Non-Small Cell Cancer AJCC v7
University of Washington
 2017-06-09 PHASE2
NCT01108666 TERMINATED
Non Small Cell Lung Cancer
Abramson Cancer Center at Penn Medicine
 2010-03 PHASE2
NCT02066311 TERMINATED
Systemic Lupus Erythematosus
Northwell Health
 2014-09 PHASE2
NCT01959672 COMPLETED
Pancreatic Adenocarcinoma; Resectable Pancreatic Carcinoma; Stage I Pancreatic Cancer; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage II Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer
University of Nebraska
 2013-09-06 PHASE2
NCT01020292 COMPLETED
Glioma
Abramson Cancer Center at Penn Medicine
 2009-04 PHASE1
NCT03422874 WITHDRAWN
Neoplasms; Lymphoma
Dartmouth-Hitchcock Medical Center
 2016-08 PHASE1
NCT02188537 COMPLETED
Myeloma
Swiss Cancer Institute
 2014-12-02 PHASE2
NCT02080416 TERMINATED
Non-Hodgkin Lymphoma; Hodgkin Lymphoma; Kaposi Sarcoma; Gastric Cancer; Nasopharyngeal Cancer; EBV; Castleman Disease
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2014-07 EARLY_PHASE1
NCT01065844 COMPLETED
Carcinoma, Adenoid Cystic; Head and Neck Neoplasms
University of Iowa
 2009-10 PHASE2
NCT01485731 COMPLETED
Cervical Cancer
University of Miami
 2012-01 PHASE1
NCT01068327 COMPLETED
Adenocarcinoma of the Pancreas; Stage III Pancreatic Cancer
University of Nebraska
 2007-11-05 PHASE1
NCT00233948 TERMINATED
Adult Liposarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
City of Hope Medical Center
 2006-03 PHASE1; PHASE2
NCT00694837 COMPLETED
Glioblastoma
Maastricht Radiation Oncology
 2009-03 PHASE1
NCT01447589 WITHDRAWN
Lung Cancer
Oxford University Hospitals NHS Trust
 2012-02 PHASE1; PHASE2
NCT01164709 COMPLETED
Leukemia; Lymphoma; Mature T-cell and Nk-cell Neoplasms; Multiple Myeloma and Plasma Cell Neoplasm
Swiss Cancer Institute
 2010-07 PHASE1
NCT00589056 COMPLETED
Lung Cancer
Abramson Cancer Center at Penn Medicine
 2007-06 PHASE1; PHASE2
NCT00234091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-04 PHASE3
NCT00915694 TERMINATED
Brain and Central Nervous System Tumors
Abramson Cancer Center at Penn Medicine
 2009-04 PHASE1
NCT01086332 TERMINATED
Pancreatic Neoplasms
University of Iowa
 2009-05 PHASE1
NCT01445106 COMPLETED
Solid Tumors
National Cancer Institute (NCI)
 2006-12-11 PHASE1
NCT01079286 COMPLETED
Renal Cell Cancer; Cancer
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2009-06 PHASE1
NCT00791336 TERMINATED
Carcinoma, Non-Small-Cell Lung
University of Iowa
 2008-08 PHASE2
NCT00099359 COMPLETED
Disease Transmission, Vertical; Vertical Human Immunodeficiency Virus Transmission; HIV Infections
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2004-02 PHASE3
NCT00704600 COMPLETED
Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal
Maastricht Radiation Oncology
 2008-09 PHASE1; PHASE2
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2005-01 PHASE1
NCT00146380 COMPLETED
HIV Infections
Centers for Disease Control and Prevention
 2003-07 PHASE2
NCT00006441 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2003-02
NCT00385450 TERMINATED
Cardiopulmonary Bypass
Mayo Clinic
 2006-10 PHASE1
NCT00246610 COMPLETED
HIV Infection
Pfizer
 2006-03 PHASE4
NCT00346619 COMPLETED
Immune Response
Mayo Clinic
 2005-10 PHASE1
NCT00457665 COMPLETED
HIV Infections
University of Texas Southwestern Medical Center
 2002-02 PHASE4
NCT00141284 COMPLETED
HIV Infection; Hepatitis C
Pfizer
 2005-10 PHASE4
NCT00192660 COMPLETED
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease
Kirby Institute
 2003-02 PHASE4
NCT00003008 COMPLETED
Sarcoma
Eastern Cooperative Oncology Group
 1997-12-15 PHASE2
NCT00346580 COMPLETED
Sepsis
Mayo Clinic
 2003-06 PHASE1
NCT00205283 COMPLETED
HIV Infections
University of Wisconsin, Madison
 2003-08
NCT00028327 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT02257008 COMPLETED
Healthy
Boehringer Ingelheim
 2003-03 PHASE1
NCT00006443 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001122 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00650637 TERMINATED
Diarrhea
Pfizer
 2003-01 PHASE3
NCT00000922 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00051844 Completed
Human Immunodeficiency Virus
Pfizer
 2002-08 Phase 2
NCT00028067 TERMINATED
HIV Infections
Bristol-Myers Squibb
 2001-08 PHASE3
NCT00002240 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-03 PHASE2
NCT00002429 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-07 PHASE3
NCT00002177 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1997-05
NCT00002176 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1997-05
NCT00002411 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1998-03
NCT00002224 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-03 PHASE3
NCT00004583 COMPLETED
HIV Infections
Abbott
 1999-03 PHASE3
NCT00001766 COMPLETED
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 1998-08 PHASE1
NCT00000941 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002374 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00044837 TERMINATED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002442 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-06 PHASE2
NCT00005002 UNKNOWN
HIV Infections
Agouron Pharmaceuticals
 PHASE3
NCT00000912 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000924 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00312182 COMPLETED
Healthy Volunteers
Pfizer
 2006-03 PHASE4
NCT00000899 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000919 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001108 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002164 COMPLETED
HIV Infections
Agouron Pharmaceuticals
 PHASE1
NCT00001087 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00004999 SUSPENDED
HIV Infections
Agouron Pharmaceuticals
 1999-08 PHASE2
NCT00006190 COMPLETED
HIV Infections; Lipodystrophy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2000-11 PHASE4
NCT00000887 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002219 UNKNOWN
HIV Infections
Gilead Sciences
 PHASE2
NCT00002378 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00002185 COMPLETED
Sarcoma, Kaposi; HIV Infections
Agouron Pharmaceuticals
 PHASE2
NCT00000885 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002381 COMPLETED
HIV Infections
Boehringer Ingelheim
 PHASE1
NCT00016601 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-06
NCT00008554 UNKNOWN
HIV Infections
Glaxo Wellcome
 2000-11 PHASE3
NCT00000913 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00122590 TERMINATED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2002-07
NCT00000892 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002165 COMPLETED
HIV Infections
Agouron Pharmaceuticals
NCT00017758 COMPLETED
HIV Infections; HIV Seronegativity; Lipodystrophy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00006326 TERMINATED
HIV Infections
Agouron Pharmaceuticals
 2000-08
NCT00005000 UNKNOWN
HIV Infections
Agouron Pharmaceuticals
 1999-12 PHASE4
NCT00002171 COMPLETED
HIV Infections
Agouron Pharmaceuticals
 PHASE2
NCT00000895 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002423 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-03 PHASE2
NCT00002375 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00001133 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000872 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002211 COMPLETED
HIV Infections
Pharmacia and Upjohn
NCT00000898 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000918 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00004998 SUSPENDED
HIV Infections
Agouron Pharmaceuticals
 1999-11 PHASE2
NCT00009061 UNKNOWN
HIV Infections
Glaxo Wellcome
 2000-11 PHASE3
NCT00002372 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00004736 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002380 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE1
NCT00002170 COMPLETED
Mycobacterium Avium-Intracellulare Infection; HIV Infections
Agouron Pharmaceuticals
 PHASE2
NCT00005762 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-03
NCT00000902 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00251030 COMPLETED
Healthy Volunteers
Pfizer
 2005-11 PHASE4
NCT00004985 COMPLETED
HIV Infections
Agouron Pharmaceuticals
 2000-01 PHASE2
NCT00002220 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE3
NCT00000859 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002440 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00541463 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 2001-01 PHASE2
NCT00000914 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002215 COMPLETED
HIV Infections
Triangle Pharmaceuticals
NCT00002216 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00002430 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00006211 COMPLETED
HIV Infections
Agouron Pharmaceuticals
 2000-02 PHASE2
NCT00002397 COMPLETED
HIV Infections; AIDS-Associated Nephropathy
Hoffmann-La Roche
 PHASE3
NCT00002235 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00005106 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-09 PHASE4
NCT00017719 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-05 PHASE3
NCT00002178 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00018083 UNKNOWN
Tuberculosis; HIV Infections
National Center for Research Resources (NCRR)
NCT00002169 COMPLETED
Cytomegalovirus Retinitis; HIV Infections
Agouron Pharmaceuticals
 PHASE2
NCT00023400 COMPLETED
HIV Infections; Tuberculosis
Centers for Disease Control and Prevention
 2000-02 PHASE4
NCT00002201 COMPLETED
HIV Infections
Abbott
NCT00001094 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000893 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 1997-10 PHASE1
NCT00002184 COMPLETED
HIV Infections
Gilead Sciences
 PHASE2
NCT00001091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000903 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-12-22)

Check the Nelfinavir Mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nelfinavir mesylate selectively binds to the active site of HIV protease with a Ki of 2 nM, blocking the post-translational processing of viral precursor polyproteins into functional viral enzymes. This inhibition prevents immature viral particle maturation and downregulates cellular Akt signaling pathways, leading to suppressed retroviral replication and therapeutic activity in clinical trials for HIV infection and solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.