NCT00763295

Brief Summary

HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function. Therefore, an accurate and reliable method for detection of latent tuberculosis in patients with HIV is urgently needed. This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB,for detection of TB in HIV-infected individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

September 28, 2008

Last Update Submit

October 25, 2012

Conditions

Latent TuberculosisHIV Infections

Keywords

latent tuberculosisHIVIFN-γ based assay

Study Arms (1)

HIV infection

Other: T-Spot.TB test

Interventions

T-Spot.TB testOTHER

diagnostic test

HIV infection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with HIV confirmed by standard methods

You may qualify if:

  • adult individuals with confirmed HIV infection

You may not qualify if:

  • Patients who are on INH treatment
  • Patients who have a positive PPD test within 1 year of study enrollment
  • Individuals with blistering or ulcerating skin disorder
  • Pregnant women
  • Patients who were given blood transfusion within 6 weeks prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Latent TuberculosisHIV Infections

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2008

First Posted

September 30, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

US(1)