Status:
COMPLETED
Faster Identification of TB and Evaluation of Drug Resistance in HIV-infected People
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
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...
Detailed Description
Early diagnosis 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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- Receipt of 7 or more cumulative days of anti-TB treatment within 12 months prior to sputum collection
- Inability to provide sputum sample
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT00959088
Start Date
August 1 2009
End Date
June 1 2012
Last Update
April 11 2013
Active Locations (3)
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1
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, Brazil, 21045
2
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, Peru, 18 PE
3
Wits HIV CRS
Johannesburg, Gauteng, South Africa