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

A5332: Randomized Trial to Prevent Vascular Events in HIV...

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months....

Read More

A5290, A Randomized, Phase 2b Study of a Double-Dose...

Rifampin (RIF), the cornerstone of TB treatment, has very problematic drug-drug interactions with PIs. The use of relatively...

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

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

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