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

P2010: Phase III Study of the Virologic Efficacy and Safety...

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a...

Read More

IMPAACT 2034 - Phase I Study of the Pharmacokinetics,...

This is a Phase I, multi-site, open-label, non-comparative study of the PK, safety, tolerability, and acceptability of a...

Read More

A5282: A Randomized, Phase II Trial to Compare an HPV...

The investigators are looking for a better way to prevent cervical cancer. This study is comparing two different methods to...

Read More

A5253: Sensitivity and Specificity of Mycobacterium...

An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with...

Read More

HPTN083: A Phase 2b/3 Double Blind Safety and Efficacy Study...

HPTN 083 is a study being done to evaluate the efficacy of the long-acting injectable agent, cabotegravir (CAB LA), for...

Read More