Collection of Tissue Specimens in Mali, West Africa, for HIV and Tuberculosis Research

NCT00341042 | Terminated

• 2 other identifiers: 99990502805-I-N028
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; HIV

Keywords

Normal Values; Complete Blood Count; HIV; Tuberculosis; Flow Cytometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Universite of Bamako

Bamako, Mali

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sophia B Siddiqui, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: January 4, 2005
• Study Completion: May 1, 2013
• Last Updated: April 5, 2018

Record last verified: 2013-05-01

Locations

MA (1)