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Gene Expression in HIV and Tuberculosis Co-infection

NCT01611402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2018-04-05

No results posted yet for this 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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Irini Sereti, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-29
Completion
2016-04-06

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611402 on ClinicalTrials.gov