NCT02822014

Brief Summary

Objective Prospectively describe the kinetics of 18F-FDG uptake of extrapulmonary TB after two months and at the end of TB treatment in HIV patients. Evaluate 18F-FDG-PET/CT as a TB treatment response monitoring tool. Design The investigators performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. The investigators correlated evolution of FDG uptake with clinical evolution of patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

2.9 years

First QC Date

June 24, 2016

Last Update Submit

June 29, 2016

Conditions

Extrapulmonary Tuberculosis in HIV Patients

Outcome Measures

Primary Outcomes (1)

  • clinical evolution of TB/HIV patients: cure or relapse within 36 months of follow-up with relapse documented microbiologically

    36 months

Study Arms (1)

FDG-PET/CT arm

OTHER

We performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. We correlated evolution of FDG uptake with clinical evolution of patients.

Other: FDG-PET/CT

Interventions

FDG-PET/CTOTHER

We performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients.

FDG-PET/CT arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected patient
  • aged at least 18 years old
  • with high clinical suspicion of extrapulmonary tuberculosis

You may not qualify if:

  • predominant neurological symptoms
  • pregnancy
  • positive smear sputum for tuberculosis
  • MDR or XDR tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 4, 2016

Study Start

February 1, 2010

Primary Completion

January 1, 2013

Study Completion

June 1, 2015

Last Updated

July 4, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share