Clinical Trials

Enfuvirtide Acetate has been evaluated across early- to late-phase clinical studies focusing on HIV, AIDS, HIV-associated lipodystrophy, and specialized populations with liver failure or progressive multifocal leukoencephalopathy. Multiple clinical trials have been sponsored by industry leaders such as Hoffmann-La Roche alongside public and academic entities, including the NIAID and ANRS. While the majority of these investigations—assessing delivery methods like needle-free devices to reduce injection-site reactions—have been completed, several clinical trials were terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01836068 COMPLETED
HIV
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2013-06 EARLY_PHASE1
NCT01022476 COMPLETED
HIV Infection; Liver Failure; Evidence of Liver Transplantation
ANRS, Emerging Infectious Diseases
 2010-05 PHASE1; PHASE2
NCT00537394 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2008-01 PHASE3
NCT00615134 COMPLETED
HIV Infections
Hoffmann-La Roche
 2008-01 PHASE2
NCT00302822 COMPLETED
HIV Infections; AIDS
French National Agency for Research on AIDS and Viral Hepatitis
 2006-04 PHASE3
NCT02582983 COMPLETED
HIV Infections
Hoffmann-La Roche
 2004-02 PHASE4
NCT00312546 TERMINATED
HIV Infections
University of North Carolina, Chapel Hill
 2006-06 PHASE1
NCT00523237 COMPLETED
HIV Infections
Stanford University
 2007-10
NCT00488059 TERMINATED
HIV Infections
Hoffmann-La Roche
 2007-06 PHASE4
NCT00460746 COMPLETED
HIV
Tibotec, Inc
 2007-05 PHASE3
NCT00454337 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2007-05 PHASE3
NCT00128830 COMPLETED
Human Immunodeficiency Virus Type 1
Tibotec Pharmaceuticals, Ireland
 2005-06 PHASE2
NCT00529243 COMPLETED
HIV Infections
Kaiser Permanente
 2007-09 PHASE3
NCT02733419 COMPLETED
HIV Infections
Hoffmann-La Roche
 2004-12 PHASE3
NCT00461266 WITHDRAWN
HIV Infections
Hoffmann-La Roche
 2007-04 PHASE4
NCT00051831 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2003-10
NCT00120367 COMPLETED
Leukoencephalopathy, Progressive Multifocal; HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2005-04 PHASE2
NCT00487188 COMPLETED
HIV Infections
Hoffmann-La Roche
 2005-11 PHASE4
NCT02569502 COMPLETED
HIV Infections
Hoffmann-La Roche
 2005-04 PHASE4
NCT00333736 COMPLETED
Human Immunodeficiency Virus
Canadian Immunodeficiency Research Collaborative
 2005-05 PHASE2
NCT00334022 COMPLETED
HIV-1
Canadian Immunodeficiency Research Collaborative
 2006-02
NCT00326963 COMPLETED
HIV Infections
Hoffmann-La Roche
 2006-03 PHASE4
NCT00344760 COMPLETED
HIV Infections
University of Maryland, Baltimore
 2005-01 PHASE4
NCT00337701 COMPLETED
HIV Infections
Hoffmann-La Roche
 2006-06 PHASE4
NCT00192660 COMPLETED
HIV-Associated Lipodystrophy Syndrome; Cardiovascular Disease
Kirby Institute
 2003-02 PHASE4
NCT00233883 COMPLETED
HIV Infections
Hoffmann-La Roche
 2005-08 PHASE4
NCT00089492 COMPLETED
HIV Infections
Hoffmann-La Roche
 2004-07 PHASE2
NCT00657761 COMPLETED
HIV Infections
Hospital Clinic of Barcelona
 2005-09 PHASE4
NCT00102934 UNKNOWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2003-03
NCT00187551 COMPLETED
HIV Infections
University of California, San Francisco
 2000-05 PHASE4
NCT00232908 COMPLETED
HIV Infections
Hoffmann-La Roche
 2004-06 PHASE4
NCT00100984 TERMINATED
HIV Infection
Hoffmann-La Roche
 2004-07-21 PHASE4
NCT00022763 COMPLETED
HIV Infections
Hoffmann-La Roche
 2001-08 PHASE2
NCT00021554 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00008528 COMPLETED
HIV Infections
Hoffmann-La Roche
 PHASE3
NCT00086710 COMPLETED
HIV Infections; AIDS
Trimeris
 PHASE1
NCT00050856 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-11 PHASE3
NCT00031044 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1; PHASE2
NCT00002239 COMPLETED
HIV Infections
Hoffmann-La Roche
 1999-05 PHASE2
NCT00001118 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002228 COMPLETED
HIV Infections
Trimeris
 PHASE2

(data from https://clinicaltrials.gov, updated on 2021-11-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enfuvirtide Acetate acts as a biomimetic HIV fusion inhibitor by binding directly to the HR1 region of viral glycoprotein gp41, thereby preventing the conformational changes necessary for viral envelope fusion with target CD4+ cell membranes. By blocking host cell entry and subsequent viral replication, the compound provides essential clinical utility in the treatment and management of HIV-1 infections.

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.