Collection of Tissue Specimens in Mali, West Africa, for HIV and Tuberculosis Research
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||January 14, 2014|
|Start Date ICMJE||January 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00341042 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Collection of Tissue Specimens in Mali, West Africa, for HIV and Tuberculosis Research|
|Official Title ICMJE||Establishment of Normal Parameters for Blood and Sputum With Samples Obtained From Volunteers in Bamako|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Estimated Enrollment ICMJE||480|
|Completion Date||May 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age 18 yrs or older.
Adequate venous access.
Willingness to allow blood samples to be stored and used for future studies of HIV infection and pathogenesis.
Ability to sign informed consent and willingness to comply with study requirements and procedures.
Anemia (Hg less than10 g/dl) (for patients donating blood only).
Underlying heart disease or bleeding disorder which in the judgment of the PI could increase the risk to the volunteer.
Fever of 101 degrees F or evidence of an acute infection. (for patients donating blood only)
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Mali|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00341042|
|Other Study ID Numbers ICMJE||999905028, 05-I-N028|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP