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

A5384: A Phase II, Randomized, Open-Label Trial of a...

Study Description A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease...

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

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

A5350: Effects of Visbiome Extra Strength on Gut Microbiome...

Many factors contribute to the development of aging-related conditions, including gastrointestinal (GI) diseases, such as...

Read More

A5300/P2003: PHOENIx Feasibility Study

Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Read More