NWCS 445: Novel Biomarkers to Shorten TB Treatment NWCS 445: Novel Biomarkers to Shorten TB Treatment: A Substudy of S31/A5349

Study Location:

India

Topic:

Tuberculosis and HIV

IRB#:

IRB00144879

Enrollment:

Closed

Trial Period:

Ongoing

Objectives:


Primary:

  • To develop a highly predictive algorithm that identifies TB patients who will be cured by treatment with shortened-duration regimens in a model that includes measured host clinical characteristics, pharmacokinetic data, and key bacterial measures. 

Secondary:

  • To test and refine measures of initial bacterial load as predictors of successful four- and six-month TB treatments
  • To test and refine measures of change in bacterial load during treatment as predictors of successful four- and six-month TB treatments
  • To investigate the contribution of M. tuberculosis sub-breakpoint minimum inhibitory concentrations as predictors of successful four- and six-month TB treatments
  • To identify simplified bacterial markers with the potential to be developed into a predictive test to identify TB patients who will be cured by treatment with shortened-duration regimens 


Partncipants enrolled in “Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized, open-label, controlled phase 3 clinical trial” (CDC TB Trials Consortium Study 31/AIDS Clinical Trials Group Study A5349 [S31/A5349]; NCT02410772)

Categories

Location
Topic

Clinical Trials

P1108: A Phase I/II, Open-Label, Single Arm Study to...

This purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of bedaquiline (BDQ) in...

Read More

P1077FF: Formula Feeding Version of the PROMISE Study...

1077FF is a randomized strategy trial, which is part of the PROMISE studies (1077BF, 1077FF, P1084s, and 1077HS). The Promoting...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled...

P1078 is a Phase IV, randomized, double-blind, placebo-controlled study of HIV-infected pregnant women and the infants born to...

Read More

A5225: Phase I/II Dose-Finding Study of High-Dose...

A5225/HiFLAC is a Phase I/II dose escalation and validation study of the safety, tolerability, and therapeutic effect of an...

Read More