TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II –III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis
DiscussionTB-PRACTECAL is an ambitious trial using adaptive design to accelerate regimen assessment and bring novel treatments that are effective and safe to patients quicker. The trial took a patient-centred approach, adapting to best practice guidelines throughout recruitment. The implementation faced significant challenges from the COVID-19 pandemic. The trial was terminated early for efficacy on the advice of the DSMB and will report on data collected up to the end of recruitment and, additionally, the planned final analysis at 72 weeks after the end of recruitment.Trial registrationClinicaltrials.gov NCT02589782.  Re...
Source: Trials - June 13, 2022 Category: Research Source Type: clinical trials

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
Conditions:   HIV Infections;   Multi-Antiviral Resistance Interventions:   Other: No ibalizumab or Pre-ibalizumab treatment;   Biological: On ibalizumab treatment Sponsors:   Theratechnologies;   Research Organization (KC) Ltd.;   Excelsus Statistics Inc.;   Health Psychology Research Group (HPR);   ICON Clinical Research Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - May 24, 2022 Category: Research Source Type: clinical trials