Amprenavir (VX-478) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials have evaluated amprenavir and its prodrug formulations across Phase I, Phase II, and unclassified study phases, all of which have reached completed status. Sponsored by pharmaceutical companies and academic medical centers, these studies assessed therapeutic applications in human immunodeficiency virus (HIV) infection, co-occurring Herpesviridae or fungal infections, and pharmacokinetic interactions in healthy volunteers. Specific investigations focused on steady-state pharmacokinetics, drug interaction profiles, and regimen optimization alongside agents like ritonavir, raltegravir, and posaconazole.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01209065	Completed	Infections Human Immunodeficiency Virus and Herpesviridae	ViiV Healthcare\|GlaxoSmithKline	2010-09	Phase 1
NCT00817765	Completed	HIV Infection\|Fungal Infection	Radboud University Medical Center\|GlaxoSmithKline	2009-01	Phase 1
NCT00802074	Completed	Healthy	Garden State Infectious Disease Associates PA\|GlaxoSmithKline	2008-12	Not Applicable
NCT00764465	Completed	Healthy	Garden State Infectious Disease Associates PA\|GlaxoSmithKline	2008-10	Phase 2

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

Check the Amprenavir (VX-478) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amprenavir selectively binds to human immunodeficiency virus (HIV) protease, forming a tight inhibitor-enzyme complex that prevents the cleavage of viral polyprotein substrates. By arresting polyprotein processing, the compound interrupts viral maturation and prevents the generation of infectious virions, underlying its efficacy in clinical trials targeting HIV infection.

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>).