Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons - Full Text View

Purpose

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 associat...

Condition

HIV Infection

MedlinePlus related topics:

AIDS

U.S. FDA Resources

Study Type:	Observational

Official Title:	Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Reproductive Fluids in HIV-Infected and HIV-Uninfected Volunteers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	1800
Study Start Date:	May 1991

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

18 years of age or older.

Adequate venous access.

Have a blood pressure less than or equal to 180/100: pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer.

Have adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 38%, platelets greater than or equal to 150,000)

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001281

Contacts


Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov

Contact: TTY	1-866-411-1010

Locations


United States, Maryland
	National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
	Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Study ID Numbers:	910140, 91-I-0140
First Received:	November 3, 1999
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00001281
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Lymphocytes

Venipuncture

Mononuclear Cells

Blood Draw

Reproductive Fluids

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001281