NCT00959088

Brief Summary

Early identification of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV is difficult, however, because 24-61% of HIV co-infected individuals with pulmonary TB have negative TB test results. In addition, conventional testing can take 6 weeks or longer and may not be available at all in many settings. This study is being conducted to see whether some new tests for identifying TB and for identifying resistance to TB drugs are at least as accurate as the current testing methods when used on HIV-infected individuals. The study will also assess whether the new tests can provide accurate results faster than the current methods.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
641

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

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

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

2.8 years

First QC Date

August 12, 2009

Last Update Submit

April 9, 2013

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples

    Throughout study

Secondary Outcomes (8)

  • GenoType Direct line probe assay results on direct sputum samples

    Throughout study

  • GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples

    Throughout study

  • Identified strains of drug resistant MTB

    Throughout study

  • AFB smear with ZN staining results

    Throughout study

  • AFB smear as evaluated with fluorescent microscopy results

    Throughout study

  • +3 more secondary outcomes

Study Arms (1)

1

HIV-infected individuals with suspected TB co-infection.

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected individuals with suspected TB co-infection

You may qualify if:

  • HIV-1 infection, as documented at any time prior to study entry by a rapid HIV test or any licensed ELISA test kit
  • Probable or confirmed pulmonary TB at the time of enrollment
  • Current use of an anti-TB regimen for treatment of active TB for fewer than 7 days prior to sputum sample collection or anticipated initiation of same within 30 days after study entry
  • Ability and willingness of participant or legal guardian/representative to provide informed consent.

You may not qualify if:

  • Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to sputum collection
  • Inability to provide sputum sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Instituto de Pesquisa Clinica Evandro Chagas (12101)

Rio de Janeiro, 21045, Brazil

Location

Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)

Lima, 18 PE, Peru

Location

Wits HIV CRS

Johannesburg, Gauteng, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

samples of sputum and blood may be retained

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Annie Luetkemeyer, MD

    San Francisco General Hospital

    STUDY CHAIR

  • Cynthia (Cindy) Firnhaber, MD

    University of Witwatersrand, South Africa

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 14, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

ZA(1)BR(1)PE(1)