Ibalizumab in Multidrug-Resistant HIV — Accepting Uncertainty

The FDA has recommended a streamlined trial design for assessing drugs’ safety and efficacy in patients with multidrug-resistant HIV infection, and ibalizumab has recently undergone such a trial. But clinicians and patients should recognize this design’s limitations.

Saved in:
Bibliographic Details
Published inThe New England journal of medicine Vol. 379; no. 7; pp. 605 - 607
Main Authors Sheikh, Virginia, Murray, Jeffrey S, Sherwat, Adam
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 16.08.2018
Subjects
Acquired immune deficiency syndrome
AIDS
Anti-HIV Agents - therapeutic use
Antibodies, Monoclonal - therapeutic use
Antiretroviral drugs
Causality
Clinical trials
Design
Disclosure
Disease
Disease Progression
Drug development
Drug resistance
Drug Resistance, Multiple, Viral
Drug screening
Food
HIV
HIV Fusion Inhibitors - therapeutic use
HIV Infections - drug therapy
Human immunodeficiency virus
Humans
Infections
Monoclonal antibodies
Multidrug resistance
Patients
Research Design
Researchers
Uncertainty
United States > US
Online AccessGet full text

Cover

More Information
Summary:The FDA has recommended a streamlined trial design for assessing drugs’ safety and efficacy in patients with multidrug-resistant HIV infection, and ibalizumab has recently undergone such a trial. But clinicians and patients should recognize this design’s limitations.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMp1808729