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Tracking Information | |||||||||
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First Received Date ICMJE | April 25, 2003 | ||||||||
Last Updated Date | August 24, 2009 | ||||||||
Start Date ICMJE | April 2003 | ||||||||
Current Primary Outcome Measures ICMJE | |||||||||
Original Primary Outcome Measures ICMJE |
To eval the effect of acyclovir prophylaxis vs placebo among HIV-1/HSV-2 co-infected individuals on the progression to AIDS (CD4+ less than 250 cells/microliter or World Health Organization [WHO] stage III/IV dx) and requirement for ART. | ||||||||
Change History | Complete list of historical versions of study NCT00059423 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE |
Meas diff in # of episodes of genital ulcer dx btw interv and placebo arms;HIV-1 viral load btw interv and placebo arms;Toxicity of acyclovir;Adherence to acyclovir; virologic/immun resp to ART in those who progress to CD+4 less than 250cells/microliter. | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Gene Message (mRNA) Analysis of Granulocytes | ||||||||
Official Title ICMJE | Peripheral Blood Granulocyte Mobilization and Gene Expression Profiling in Adult Individuals of African Descent, With and Without Benign Ethnic Neutropenia | ||||||||
Brief Summary | In recent decades, hematologists have noticed that persons of African descent sometimes have lower white blood cell counts of a certain type, called granulocytes. These cells help to fight infections. The lower number of granulocytes in this situation does not appear to lead to more infections, and these individuals do not have any symptoms. This condition is called benign ethnic neutropenia (BEN), and is observed in a small percentage of individuals of African descent. This study will investigate the condition by studying people with and without BEN. The goals of this study are to:
Study participants will be asked to interview with the research team, undergo physical exams, donate a blood sample, and receive G-CSF by injection, followed by dexamethasone (orally) about three weeks later. They also will be required to undergo apheresis three times, a procedure in which blood is drawn from a donor and separated into its components. Some components are retained for research analyses, such as granulocytes, and small amount of blood; the remainder is returned by transfusion to the donor. This procedure will be required of participants before they receive G-CSF, the day after they receive G-CSF, and the day after they receive dexamethasone. Gene messages (mRNA will be isolated from granulocytes, and analyzed to better understand granulocyte growth and movement. |
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Detailed Description | Benign ethnic neutropenia (BEN) is defined by peripheral blood absolute neutrophil count less than 1.5 x 10(9) per liter without an increase in infections. This condition has been described in individuals of African descent. Although these individuals have normal myeloid maturation on bone marrow examinations, they appear to release fewer neutrophils into the circulation when stimulated by hydrocortisone, compared to normal controls. This suggests that there may be differences in the regulation of neutrophil release or trafficking. In the past decade, granulocyte-colony stimulating factor (G-CSF) has been widely used in a variety of clinical settings, from patients with chemotherapy-induced neutropenia to normal volunteers for peripheral blood stem cell collection. G-CSF, however, has not been used in individuals with BEN. Furthermore, gene expression in neutrophil proliferation and trafficking has not been studied in these individuals. The purpose of this study is to identify individuals with BEN; to characterize and compare neutrophil response to dexamethasone and G-CSF; to compare the pattern of neutrophil gene expression by microarray analyses; to determine if mutations are present at the DNA level to account for gene expression pattern differences, in individuals of African descent with and without BEN at baseline, post dexamethasone, and post G-CSF stimulation and to follow the natural history of BEN. |
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Study Phase | |||||||||
Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | |||||||||
Condition ICMJE | Neutropenia | ||||||||
Intervention ICMJE | |||||||||
Study Arms / Comparison Groups | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Enrollment ICMJE | 99999999 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | March 2005 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Individuals of African descent of age 18 or greater Normal renal function: creatinine less than 1.5 mg/dl and proteinuria less than 1+ Normal liver function: bilirubin less than 1.5 mg/dl and transaminases within normal limits For CONTROL subjects: WBC within normal range (3,300 -9,600/mm(3)), granulocytes greater than or equal to 1,500/mm(3), platelets greater than 150,000/mm(3), hemoglobin greater than 11.5 g/dL, and normal MCV For BENIGN ETHNIC NEUTROPENIC subjects: two blood counts, at least 1 month apart, in the last 6 months, with granulocytes less than 1,500/mm(3), platelet greater than 150,000/mm(3), hemoglobin greater than 12.5 g/dL, and normal MCV Female volunteers of childbearing age should not be pregnant Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research uses (negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1) Ability to give informed consent to participate in the protocol EXCLUSION CRITERIA: Any underlying hematologic disorder including anemia, thalassemia, and sickle cell trait or disease Current use of corticosteroids, e.g. prednisone, dexamethasone, or hydrocortisone. Corticosteroids must be discontinued at least one month prior Active or chronic viral, bacterial, fungal, or parasitic infection. Any antibiotic use should be discontinued at least one month prior History of autoimmune disease, such as rheumatoid arthritis or systemic lupus erythematosus, or positive anti-nuclear antibody (ANA ELISA) of 3 E.U. (ELISA units) or greater Low B12 or folate levels, or abnormal thyroid function tests History of cancer or chemotherapy, except squamous carcinoma of the skin and cervical carcinoma in situ Pregnant woman or positive urine pregnancy test History of clinically significant cardiovascular disease (cardiology consultation may be obtained when clinically indicated). Any positive serum screening test as listed below Allergy to G-CSF or bacterial E. coli products |
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID ICMJE | NCT00059423 | ||||||||
Responsible Party | |||||||||
Study ID Numbers ICMJE | 030168, 03-H-0168 | ||||||||
Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
Investigators ICMJE | |||||||||
Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | January 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |