NWCS 414, Evaluation of a Serum Biosignature for Identifying HIV-infected Individuals at Greatest risk for Developing Active TB

Study Location:

India

Topic:

Tuberculosis and HIV

IRB#:

IRB00123874

Enrollment:

Closed

Trial Period:

Ongoing

We will address our hypothesis using a case-control study design. We plan to leverage the existing biorepository of longitudinally collected serum samples through the REMEMBER (Reducing Early Mortality & Early Morbidity by Empiric Tuberculosis Treatment Regimens) ACTG5274 study, which involves serial serum collection from advanced HIV-infected subjects (CD4<50), who did (experimental subjects) and did not develop TB (negative controls) within 24 weeks post-ART. Altogether, serum samples have been collected from approximately 50 cases at the time of TB diagnosis. Serum will be evaluated for the metabolite/miRNA biosignature in cases and negative controls matched on the same two strata used at entry into the parent trial (CD4<25 cells/ml vs. CD4= 26-50 cells/ml and presence vs. absence of poor prognostic factors). Metabolites will be analyzed by LC-MS/MS at Metabolon, and miRNAs will be analyzed by microarrays and reverse-transcriptase PCR (RT-PCR) at Johns Hopkins.

N/A

Categories

Location
Topic

Clinical Trials

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

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

A5314: Effect of LDMTX on Inflammation in HIV-infected...

A5314 is a phase II randomized, double-blind, placebo-controlled 36-week trial that will examine the safety and efficacy of...

Read More

A5361s: Pitavastatin to REduce Physical Function Impairment...

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants...

Read More

A5128: Consent for Use of Stored Patient Specimens for...

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other...

Read More