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

A5207, Maintaining Options for Mothers Study (MOMS): A Phase...

A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional resistance to...

Read More

The Pharmacokinetics, Safety and Acceptability of New...

PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of...

Read More

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate...

This study is currently on hold. The study is designed to characterize the pharmacokinetics of DLM using a model-based...

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

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