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

A5342: Evaluating the Safety, Tolerability, and Effect of a...

The purpose of this study is to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody...

Read More

A5322: Long-Term Follow-up of Older HIV-infected Adults in...

The A5322 protocol is a long-term observational study, with a planned series of analyses of data to be collected from an...

Read More

P1077BF: Breastfeeding Version of the PROMISE Study...

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

Read More

ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients...

Rationale: There is an urgent need for a platform to rapidly evaluate therapies in the outpatient setting, to prevent disease...

Read More

A5349: Rifapentine-containing treatment shortening regimens...

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a...

Read More