Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341042
Status:
TERMINATED
Last Update Posted:
2018-04-05
First Post:
2006-06-19
Brief Title:
Collection of Tissue Specimens in Mali West Africa for HIV and Tuberculosis Research
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Establishment of Normal Parameters for Blood and Sputum With Samples Obtained From Volunteers in Bamako
Status:
TERMINATED
Status Verified Date:
2013-05-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted in Bamako Mali West Africa will collect blood and sputum samples to establish normal values for laboratory test results among Malians Researchers are starting a new initiative to study HIV and tuberculosis in Africa using Mali as a model country In order to perform these studies the scientists need to know what constitutes normal laboratory values among the population People in developing countries may have dramatically different laboratory values from those who live in developed countries and there is currently little information available to distinguish normal from abnormal results in Malians This study will establish normal ranges that will provide a basis for future HIV and tuberculosis research in Mali Additionally it will provide blood and sputum samples to researchers to study different scientific questions related to HIV and Tuberculosis infection
Healthy volunteers and people infected with HIV or tuberculosis or both who are 18 years of age or older and who live in Bamako Mali may be eligible for this study Candidates are screened with a medical history physical examination and blood test
Participants provide a blood or sputum sample or both for laboratory analysis Blood is collected through a needle inserted into an arm vein and sputum is collected by having the participant cough deeply and spit in a cup Participants may agree to provide samples one time only or on a returning visit basis Returning visits may be scheduled daily or weekly Subjects may continue to participate for the duration of the 4-year study provided their medical history and physical examination are updated once a year
Healthy volunteers and people infected with HIV or tuberculosis or both who are 18 years of age or older and who live in Bamako Mali may be eligible for this study Candidates are screened with a medical history physical examination and blood test
Participants provide a blood or sputum sample or both for laboratory analysis Blood is collected through a needle inserted into an arm vein and sputum is collected by having the participant cough deeply and spit in a cup Participants may agree to provide samples one time only or on a returning visit basis Returning visits may be scheduled daily or weekly Subjects may continue to participate for the duration of the 4-year study provided their medical history and physical examination are updated once a year
Detailed Description:
HIV and tuberculosis are major health issues in the developing world - HIV and tuberculosis affect several million people worldwide Individually and together these two diseases kill more people than any other infections with the worst suffering occurring on the African continent Mali is a West African state awakening to the reality of these issues While tuberculosis has always been a major problem in Mali more recently HIV incidence has begun to increase
We are commencing a new research initiative to study HIV and tuberculosis in Africa using Mali as a model country However there is little baseline epidemiological hematological immunological or microbiological data to help distinguish normal from abnormal results establishing normal population baseline values is necessary to facilitate future research We will collect whole blood and sputum samples to establish baseline values for the purpose of facilitating ongoing or future HIV and tuberculosis research Specifically samples will be used to determine normal hematological immunological and other parameters for Malian people In addition we will use samples to optimize routine and specialized research assays Sputum samples will be used in bacteriological and genetic studies intended to optimize studies relating to tuberculosis
We are commencing a new research initiative to study HIV and tuberculosis in Africa using Mali as a model country However there is little baseline epidemiological hematological immunological or microbiological data to help distinguish normal from abnormal results establishing normal population baseline values is necessary to facilitate future research We will collect whole blood and sputum samples to establish baseline values for the purpose of facilitating ongoing or future HIV and tuberculosis research Specifically samples will be used to determine normal hematological immunological and other parameters for Malian people In addition we will use samples to optimize routine and specialized research assays Sputum samples will be used in bacteriological and genetic studies intended to optimize studies relating to tuberculosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-N028 | None | None | None |