Optimized Background Regimen

DRUG4 trials

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis, Otsuka Pharmaceutical Development & Commercialization, Inc., CytoDyn, Inc., TaiMed Biologics Inc.

Conditions

HIVHIV InfectionsMultidrug Resistant TuberculosisPediatric

Phase 1

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

CompletedNCT01856634

Otsuka Pharmaceutical Development & Commercialization, Inc.Multidrug Resistant Tuberculosis, Pediatric

Start: 2013-06-14End: 2017-12-28Updated: 2018-01-30

Phase 2

Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses

CompletedNCT00460382

French National Agency for Research on AIDS and Viral HepatitisHIV Infections

Start: 2007-05-31End: 2009-09-30Updated: 2010-09-17

Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140

CompletedNCT02483078

CytoDyn, Inc.HIV

Start: 2015-10-31End: 2018-07-31Updated: 2022-11-03

Phase 3

Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

CompletedNCT02707861

TaiMed Biologics Inc.HIV

Start: 2016-03-31End: 2018-11-30Updated: 2021-03-11

Related Papers

Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced People Living With Multidrug-Resistant HIV-1: A Phase 3, Multicenter, Expanded Access Study

JAIDS Journal of Acquired Immune Deficiency Syndromes2025-06-04

QT Interval Prolongation and Second-line Antituberculosis Medicines in Children: An Update and Practical Considerations for Noncardiologists

The Pediatric Infectious Disease Journal2023-02-03

Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial.

2022-04-1112 citations