NIH Clinical Research Studies

Protocol Number: 91-I-0140

Active Accrual, Protocols Recruiting New Patients

Title:
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Reproductive Fluids in HIV-Infected and HIV-Uninfected Volunteers
Number:
91-I-0140
Summary:
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.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility 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.

Special Instructions: Currently Not Provided
Keywords:
Lymphocytes
Venipuncture
Mononuclear Cells
Blood Draw
Reproductive Fluids
Recruitment Keywords:
None
Conditions:
HIV Infection
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

Active Accrual, Protocols Recruiting New Patients

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