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

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

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

HPTN 078: Enhancing Recruitment, Linkage to Care and...

The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable...

Read More

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled...

P1078 is a Phase IV, randomized, double-blind, placebo-controlled study of HIV-infected pregnant women and the infants born to...

Read More

NWCS 408: Examining Longitudinal Cytokine Profiles in HIV-TB...

Using existing data from A5274 and data obtained from retrospectively testing available biospecimens, we propose the following...

Read More