TuberculosisNCT00341042
Collection of Tissue Specimens in Mali, West Africa, for HIV and Tuberculosis Research
An observational study of Tuberculosis and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, HIV
- How many people
- 253 participants
- Where
- 1 siteMali
- Study dates
- 4 Jan 2005to 1 May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tuberculosis, HIV
- Keywords
- Normal Values, Complete Blood Count, HIV, Tuberculosis, Flow Cytometry
- Medical subject headings
- Tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start4 Jan 2005
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Sophia B Siddiqui, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341042
- Sponsor's protocol ID
- 999905028
- Other IDs
- 05-I-N028
- Status last verified
- 1 May 2013
- First submitted
- 19 Jun 2006
- Last updated
- 5 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Normal Parameters for Blood and Sputum With Samples Obtained From Volunteers in Bamako
- ClinicalTrials.gov ID
- NCT00341042
- Acronym / sponsor ID
- 999905028
- Conditions
- Tuberculosis, HIV
- Keywords
- Normal Values, Complete Blood Count, HIV, Tuberculosis, Flow Cytometry
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 253 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 4 Jan 2005
- Study completion
- 1 May 2013
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia B Siddiqui, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.