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Home > "S" Clinical Trials Conditions > Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons  Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons
Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons
For Condition: HIV Infection
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will examine the effects of HIV infection on substances produced by immune cells that increase or decrease HIV infection. HIV-infected patients and healthy normal volunteers may be eligible for this study. Participants will be required to have a yearly medical evaluation, including blood tests for cell counts and chemistries, a blood or urine pregnancy test for women, and other laboratory tests as medically indicated or for research purposes. Participants will donate blood or reproductive fluids, or both. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be drawn from the arm using a small needle. Participants may be asked to provide blood samples on more than one occasion over the course of the study. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Males will be given a private room for semen donation; fluid from females will be collected with a cotton swab after speculum insertion. Participants may also be asked to have a buccal swab. For this procedure, the inside of the cheek is gently scraped with a blunt-ended stick or brush to obtain cells (buccal mucosal cells). The tissues will be used for a variety of studies on the effects of HIV infection on factors that increase or decrease HIV infection. Some of the tissues collected for this study may also be used for the following tests: - Hepatitis screening - Blood may be screened for different types of viral liver infections, such as hepatitis A, B, C, D, E, or G. - Genetic testing - DNA from blood or cheek cells may be examined for mutations or deletions that affect chemokines, cytokines and a family of enzymes called caspases. Chemokines and cytokines are important mediators of the immune response. Alterations in the genes for some of these substances influence HIV infection. Caspases regulate the process of cell death, known as apoptosis. Caspase gene variations may determine the rate of cell death in HIV-infected persons, and therefore, the rate of HIV progression. Patients with abnormalities of any of these genes may be invited to join other studies of the role of genetic defects in HIV infection. - HLA testing - Blood may be tested for HLA type-a genetic marker of the immune system. These tests may be used to try to identify factors associated with the rate of progression of HIV disease or related conditions. Determining HLA type is necessary to be able to perform certain research studies. Some HLA types have been associated with an increased risk of certain diseases like arthritis and other rheumatologic problems.
Details: We are requesting permission to undertake these studies for the following reasons. We are studying the pathogenesis of HIV infection. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection using human peripheral blood mononuclear cells as a model.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 18 years of age or older. Both males and females. Adequate venous access. Hgb greater than 12 g/dL. Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening. Able to sign informed consent, willingness to comply with study requirements and clinic policies, and willingness and ability to undergo study procedures. EXCLUSION CRITERIA: Pregnant and/or breastfeeding females. Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
Total Enrollment: 1200
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 910140; 91-I-0140
Study Start Date: May 17, 1991
Record last reviewed: May 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001281
Other Hiv Infection Studies:
1. Pharmacokinetics of Antiretroviral Agents in HIV-1 Infected Pregnant Women
2. Genetic Factors and Interrelationships for Sexual Orientation, Susceptibility to HIV and Kaposi's Sarcoma, Alcoholism and Psychological Traits, and Histocompatibility Antigens
3. Phase I Study of APL 400-003, a Candidate HIV Vaccine, in HIV-Negative Volunteers
4. Screening Patients for NCI Protocol Eligibility
5. Screening HIV-Infected Patients for Vaccine Studies
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons
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