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NCT01611402 · ClinicalTrials.gov registry record

Gene Expression in HIV and Tuberculosis Co-infection

A clinical trial of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
96
Enrollment target
1
Study location

NCT01611402 is a study of Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 96 participants, below the 931-participant average among 29 other Tuberculosis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01611402, a study of Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
96 participants
Enrollment target
1
Study location

Study Summary

Background: \- Tuberculosis (TB) infection is particularly deadly when it happens in people who are also infected with the human immunodeficiency virus (HIV). However, not much is known about how these two infections affect each other. Some people who have HIV or TB infections develop health problems after they start taking either HIV or TB medications or both. These drugs can improve the body s ability to fight infections, but sometimes this sudden improvement can make the infected person initially become sicker. Researchers want to study how these infections affect the immune system and the gene expression of people who have TB and may or may not have HIV, to see if there is a pattern of gene expression that may predict whether people starting treatment may get sicker initially. Objectives: \- To study the gene expression and immune systems of people with TB who may or may not also have HIV. Eligibility: * Adults at least 18 years of age who have tuberculosis. * Participants will be drawn from study sites in the United States and China. Design: * Participants will be divided into three study groups. The first group will have TB but not HIV. The second group will have both TB and HIV that have not been treated. The third group will have both TB and HIV that are currently being treated. * All participants will have a single study visit. Blood samples will be collected at this visit. A medical history will also be collected. * No treatment will be provided as part of this study.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2012-05-29
Est. Completion 2016-04-06

What the Registry Record Tells You About NCT01611402

The ClinicalTrials.gov registry entry for NCT01611402 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 931-participant average among 29 other Tuberculosis trials with a reported enrollment target (90% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 0 interventions.

NCT01611402 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01611402 about?

NCT01611402 is a clinical study titled "Gene Expression in HIV and Tuberculosis Co-infection". Background: \- Tuberculosis (TB) infection is particularly deadly when it happens in people who are also infected with the human immunodeficiency virus (HIV). However, not much is known about how these two infections affect each other. Some people who have HIV or TB infections develop health proble...

What is the current status of trial NCT01611402?

This trial is currently completed. The enrollment target is 96 participants. The study started on 2012-05-29. Estimated completion is 2016-04-06.

What conditions does trial NCT01611402 study?

This clinical trial studies the following conditions: Tuberculosis.

Who is sponsoring clinical trial NCT01611402?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01611402 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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