Optimized Background Regimen (OBR)

DRUG9 trials

Sponsors

Boehringer Ingelheim, Tibotec Pharmaceuticals, Ireland, Otsuka Pharmaceutical Development & Commercialization, Inc., Boston University, TaiMed Biologics Inc.

Conditions

Extensively Drug-Resistant TuberculosisHIVHIV InfectionsHIV-1HIV-1-infectionMultidrug Resistant TuberculosisTuberculosisTuberculosis, Multidrug Resistant

Phase 2

TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

CompletedNCT00665847

Tibotec Pharmaceuticals, IrelandHIV-1

Start: 2008-11-30End: 2011-08-31Updated: 2015-04-23

A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)

CompletedNCT00685360

Otsuka Pharmaceutical Development & Commercialization, Inc.Extensively Drug-Resistant Tuberculosis, Tuberculosis, Multidrug Resistant, Tuberculosis, Pulmonary

Start: 2008-05-08End: 2010-06-11Updated: 2021-12-01

Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

TerminatedNCT01131351

Otsuka Pharmaceutical Development & Commercialization, Inc.Tuberculosis

Start: 2010-02-19End: 2011-05-12Updated: 2021-11-11

A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

CompletedNCT01859923

Otsuka Pharmaceutical Development & Commercialization, Inc.Multidrug Resistant Tuberculosis

Start: 2013-07-20End: 2020-01-13Updated: 2020-11-23

Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB

CompletedNCT01918397

Boston UniversityTuberculosis, Multidrug-Resistant

Start: 2015-01-31End: 2022-03-29Updated: 2023-05-24

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

Active, not recruitingNCT04150068

Gilead SciencesHIV-1-infection

Start: 2019-11-21End: 2027-01-01Updated: 2026-03-13

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

RecruitingNCT06749054

Gilead SciencesHIV-1-infection

Start: 2025-03-26End: 2027-04-30Target: 12Updated: 2025-12-02

Phase 3

SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC

TerminatedNCT00440271

Boehringer IngelheimHIV Infections

Start: 2007-02-28Updated: 2014-06-27

Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

CompletedNCT02475629

TaiMed Biologics Inc.HIV

Start: 2015-08-31End: 2016-12-31Updated: 2020-03-19

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