NCT01611402

Gene Expression in HIV and Tuberculosis Co-infection

Completed Last updated 5 April 2018

What this trial tests

trial in Tuberculosis in 96 participants. Completed in 6 April 2016.

Timeline

29 May 2012

6 April 2016

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	96
Start date	29 May 2012
Estimated completion	6 April 2016
Sites	1 location across United States

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lysosomal Cathepsin Release Is Required for NLRP3-Inflammasome Activation by <i>Mycobacterium tuberculosis</i> in Infected Macrophages.
   Amaral EP, Riteau N, Moayeri M, Maier N, et al · · 2018 · cited 95× · PMID 29977244 · DOI 10.3389/fimmu.2018.01427
2. Heme Oxygenase-1 Regulation of Matrix Metalloproteinase-1 Expression Underlies Distinct Disease Profiles in Tuberculosis.
   Andrade BB, Pavan Kumar N, Amaral EP, Riteau N, et al · · 2015 · cited 53× · PMID 26268658 · DOI 10.4049/jimmunol.1500942
3. Evaluation of Canonical Inflammasome Activation in Human Monocytes by Imaging Flow Cytometry.
   Lage SL, Dominical VM, Wong CS, Sereti I. · · 2019 · cited 25× · PMID 31214205 · DOI 10.3389/fimmu.2019.01284
4. Cathepsin K Contributes to Cavitation and Collagen Turnover in Pulmonary Tuberculosis.
   Kubler A, Larsson C, Luna B, Andrade BB, et al · · 2016 · cited 25× · PMID 26416658 · DOI 10.1093/infdis/jiv458
5. Classical complement and inflammasome activation converge in CD14highCD16- monocytes in HIV associated TB-immune reconstitution inflammatory syndrome.
   Lage SL, Wong CS, Amaral EP, Sturdevant D, et al · · 2021 · cited 6× · PMID 33788899 · DOI 10.1371/journal.ppat.1009435