Clinical Trials

Numerous clinical trials evaluate saquinavir from Early Phase 1 through Phase 4, primarily focusing on Human Immunodeficiency Virus (HIV) infections alongside secondary indications including pulmonary arterial hypertension, sarcoma, and cardiovascular disorders. Encompassing completed, actively recruiting, withdrawn, and terminated cohorts, key investigations have evaluated combination antiretroviral regimens and formulation efficacy. These research efforts are supported by a diverse array of sponsors, including pharmaceutical corporations, academic medical centers, and public research agencies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05997693 Not yet recruiting
Chronic Coronary Disease
Weill Medical College of Cornell University|Canadian Institutes of Health Research (CIHR)
 2024-10 Phase 3
NCT06406218 Recruiting
Acute Myocardial Infarction|Phase I Cardiac Rehabilitation
Han Yaling MD|Shenyang Northern Hospital
 2024-04-24 Not Applicable
NCT06340009 Recruiting
Bell Palsy
Riphah International University
 2024-03-22 Not Applicable
NCT02023450 UNKNOWN
Pulmonary Arterial Hypertension
The Third Xiangya Hospital of Central South University
 2013-12 EARLY_PHASE1
NCT01638650 COMPLETED
HIV Infections
Hoffmann-La Roche
 2012-01 PHASE1
NCT00623597 COMPLETED
HIV Infections
Hoffmann-La Roche
 2008-06 PHASE2
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2005-01 PHASE1
NCT00435929 COMPLETED
HIV Infections
Hoffmann-La Roche
 2006-09 PHASE1
NCT00438152 COMPLETED
HIV Infections
Royal Free Hampstead NHS Trust
 2006-09 PHASE4
NCT00717067 COMPLETED
Human Immunodeficiency Virus (HIV) Infection
ViiV Healthcare
 2008-07 PHASE4
NCT00476359 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2003-10 PHASE4
NCT00379405 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2006-06 PHASE4
NCT00477048 COMPLETED
IDV Associated Nephrotoxicity
The HIV Netherlands Australia Thailand Research Collaboration
 2004-05 PHASE2
NCT00622206 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2008-01 PHASE1; PHASE2
NCT00145561 COMPLETED
HIV Infections
Radboud University Medical Center
 2005-08 PHASE1; PHASE2
NCT00051831 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2003-10
NCT00050180 COMPLETED
Healthy; HIV Infections
National Institutes of Health Clinical Center (CC)
 2002-11-22 PHASE4
NCT00105079 COMPLETED
HIV Infections
Hoffmann-La Roche
 2005-04 PHASE3
NCT00400738 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2004-03 PHASE2
NCT00192660 COMPLETED
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease
Kirby Institute
 2003-02 PHASE4
NCT00003008 COMPLETED
Sarcoma
Eastern Cooperative Oncology Group
 1997-12-15 PHASE2
NCT00192608 COMPLETED
HIV Infections
Kirby Institute
 2004-11
NCT00100984 TERMINATED
HIV Infection
Hoffmann-La Roche
 2004-07-21 PHASE4
NCT00056641 COMPLETED
HIV Infections
Boehringer Ingelheim
 2003-02-18 PHASE2
NCT00035932 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2001-11 PHASE3
NCT00046033 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00004584 COMPLETED
HIV Infections
Bristol-Myers Squibb
 1999-12 PHASE2
NCT02239835 TERMINATED
HIV Infections
Boehringer Ingelheim
 1999-12 PHASE2
NCT02184286 TERMINATED
HIV Infections
Boehringer Ingelheim
 1999-05 PHASE1
NCT00001040 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE2
NCT00002178 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00002425 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE4
NCT00622141 WITHDRAWN
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 PHASE1; PHASE2
NCT00001094 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002184 COMPLETED
HIV Infections
Gilead Sciences
 PHASE2
NCT00002383 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE1
NCT00002162 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE2
NCT00002447 COMPLETED
HIV Infections
Hoffmann-La Roche
 1999-10 PHASE3
NCT00002367 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00000891 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000920 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00038532 COMPLETED
HIV Infections
Abbott
 2001-04 PHASE2
NCT00000941 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002190 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE2
NCT00002374 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00002111 COMPLETED
HIV Infections
Stanford University
 PHASE1
NCT00084058 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1; PHASE2
NCT00038519 COMPLETED
HIV Infections
Abbott
 2001-04 PHASE2; PHASE3
NCT00000912 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002448 COMPLETED
HIV Infections
Hoffmann-La Roche
 1999-10 PHASE3
NCT00002347 COMPLETED
HIV Infections
Parexel
 PHASE2
NCT00001108 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00001087 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002229 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE4
NCT00002382 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00000906 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002333 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE2
NCT00002378 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00102206 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000913 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000848 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000892 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00043953 COMPLETED
HIV Infections
Abbott
 2002-08 PHASE2
NCT00001133 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000898 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00389402 COMPLETED
HIV Infections
International Antiviral Therapy Evaluation Center
 2006-07 PHASE4
NCT00000918 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002372 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00002380 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE1
NCT00476983 WITHDRAWN
Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID
The HIV Netherlands Australia Thailand Research Collaboration
 PHASE2; PHASE3
NCT00122603 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2005-12 PHASE2
NCT00005762 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2001-03
NCT00002334 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00002440 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE2
NCT00002397 COMPLETED
HIV Infections; AIDS-Associated Nephropathy
Hoffmann-La Roche
 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Saquinavir (Ro 31-8959) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Saquinavir selectively binds to and inhibits HIV proteinase, preventing the enzymatic cleavage of viral polyproteins essential for structural assembly. This inhibition halts viral maturation and leads to the formation of immature, non-infectious viral particles, thereby blocking viral propagation in host cells. Consequently, this mechanistic blockade reduces viral load, directly underpinning its therapeutic evaluation for Human Immunodeficiency Virus (HIV) infections in clinical trials.

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>).

Jump to

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