Status:
COMPLETED
Immune Responses to Mycobacterium Tuberculosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
This study, conducted at the University of Mali in the capital city of Bamako, will investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the organism that causes tubercu...
Detailed Description
Tuberculosis is a daunting global health problem. The solution requires development of an effective vaccine. But incomplete understanding of Mycobacterium tuberculosis (MTB) immunity-how it is acquire...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Ability to sign informed consent and willingness to comply with study requirements (including storage of blood specimens for future research on HIV, AIDS, MTB or the immune system).
- CATEGORY-SPECIFIC MTB INCLUSION CRITERIA:
- Group A (HIV-/MTB\[BCG\]) HIV ELISA(2) negative; BCG vaccinated with TST(2) less than 15 mm
- Group B (HIV+/MTB\[BCG\]) HIV ELISA/WB(2) positive; BCG vaccinated with TST less than 5 mm
- Group C (HIV-/MTB\[pulm\]) HIV ELISA negative; pulmonary MTB
- Group D (HIV-/MTB\[diss\]) HIV ELISA negative; disseminated MTB
- Group E (HIV+/MTB\[pulm\]) HIV ELISA/WB positive; pulmonary MTB
- Group F (HIV+/MTB\[diss\]) HIV ELISA/WB positive; disseminated MTB
- EXCLUSION CRITERIA:
- Age less than 18 years (because of the risk for inducing protocol-related anemia)
- Hg less than 7.5 g/dL
- Latent MTB infection (as evidenced by a TST greater than 5 mm if HIV infected or greater than 15 mm if HIV uninfected) for arms A and B only.
- Past history of treated MTB infection
- Known or underlying bleeding disorder (due to risk of bleeding from venipuncture)
- Psychiatric illness that might interfere with study compliance
- Use of immunomodulators (including corticosteroids and IL-2) or cytotoxic agents (including hydroxyurea) within 45 days of signing consent and at any time during study
- Small or difficult to access antecubital veins that make venipuncture difficult
Exclusion
Key Trial Info
Start Date :
October 6 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2015
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00340990
Start Date
October 6 2003
End Date
November 27 2015
Last Update
December 5 2019
Active Locations (1)
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1
University of Mali
Bamako, Mali