Clinical Trials

Numerous early- to late-phase clinical trials evaluate the safety, antiretroviral efficacy, and pharmacokinetic profile of indinavir sulfate in diverse populations. These studies target HIV infection, cardiovascular conditions like hypertension, and oncology indications including Kaposi's and Ewing's sarcomas. Sponsored by public entities such as the National Institute of Allergy and Infectious Diseases alongside pharmaceutical developers including Merck Sharp & Dohme, Glaxo Wellcome, and Bristol-Myers Squibb, the majority of trials are completed, while several have been withdrawn, terminated, or suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01067690 COMPLETED
Kaposi's Sarcoma
Barbara Ensoli, MD, PhD
 2008-06 PHASE2
NCT00001644 COMPLETED
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 1997-03-03 PHASE1
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2005-01 PHASE1
NCT00637637 UNKNOWN
Cancer
Oncology Institute of Southern Switzerland
 2007-09 PHASE2
NCT00411996 COMPLETED
HIV Infections; Tuberculosis
The HIV Netherlands Australia Thailand Research Collaboration
 2006-12 PHASE1; PHASE2
NCT00001566 COMPLETED
Ewing's Sarcoma; Rhabdomyosarcoma
National Cancer Institute (NCI)
 1996-12 PHASE2
NCT00050180 COMPLETED
Healthy; HIV Infections
National Institutes of Health Clinical Center (CC)
 2002-11-22 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
NCT00001119 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 1999-10
NCT00006443 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000875 TERMINATED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000922 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000804 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000882 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002371 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1996-06 PHASE3
NCT00002354 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00002233 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00002351 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE1
NCT00039975 COMPLETED
HIV Infections; Cardiovascular Diseases; Hypertension
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002376 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE4
NCT00002361 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00000870 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000850 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002208 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE3
NCT00001083 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000903 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002179 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE4
NCT00002387 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00002386 COMPLETED
HIV Infections; Hemophilia A
Merck Sharp & Dohme LLC
 PHASE4
NCT00000841 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00000877 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002401 COMPLETED
HIV Infections
Pharmacia and Upjohn
NCT00002369 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00002451 UNKNOWN
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00000861 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002442 COMPLETED
HIV Infections
Glaxo Wellcome
 1999-06 PHASE2
NCT00000896 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00148785 COMPLETED
HIV Infections
Emory University
 2005-07 PHASE4
NCT00001095 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00362310 COMPLETED
Classical Kaposi's Sarcoma
Istituto Superiore di Sanità
 2003-06 PHASE2
NCT00012519 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1; PHASE2
NCT00002241 UNKNOWN
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00000912 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000916 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002199 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00000919 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002443 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00002410 COMPLETED
HIV Infections
Dupont Merck
 PHASE3
NCT00002223 COMPLETED
HIV Infections
Abbott
NCT00001086 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002155 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00006339 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00005118 UNKNOWN
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00002379 COMPLETED
HIV Infections
Gilead Sciences
 PHASE2
NCT00000885 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00016601 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-06
NCT00000901 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000848 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)
NCT00000944 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00006326 TERMINATED
HIV Infections
Agouron Pharmaceuticals
 2000-08
NCT00006154 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
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
NCT00006397 UNKNOWN
HIV Infections
PPD Development, LP
 2000-08 PHASE3
NCT00120783 TERMINATED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2002-02 PHASE2
NCT00000918 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00011635 COMPLETED
HIV Infection; Healthy
National Institutes of Health Clinical Center (CC)
 2001-02 PHASE1
NCT00002202 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE3
NCT00002372 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00002236 COMPLETED
HIV Infections
Pharmacia and Upjohn
NCT00002424 SUSPENDED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00158405 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2002-12 PHASE3
NCT00027339 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002400 COMPLETED
HIV Infections
Pharmacia and Upjohn
NCT00000923 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002407 COMPLETED
HIV Infections
Weill Medical College of Cornell University
NCT00005762 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-03
NCT00001084 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002168 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00002220 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE3
NCT00001443 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
National Cancer Institute (NCI)
 1995-07 PHASE1
NCT00000859 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002440 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00002452 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2
NCT00001058 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002393 COMPLETED
HIV Infections
Dupont Merck
 PHASE3
NCT00541463 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 2001-01 PHASE2
NCT00000914 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002430 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
NCT00002406 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE3
NCT00002235 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 PHASE2

(data from https://clinicaltrials.gov, updated on 2016-08-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indinavir sulfate selectively binds to the active site of the HIV-1 protease enzyme, inhibiting the proteolytic processing of viral gag-pol polyprotein precursors into essential structural and functional viral proteins. This inhibition prevents the cleavage necessary for viral maturation, resulting in the production of immature, non-infectious virions and establishing its therapeutic utility in clinical trials targeting HIV infection and associated malignancies such as Kaposi's sarcoma.

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.