Trial record 10 of 118 for:    NIAID | Recruiting, Not yet recruiting, Available Studies | Acquired Immunodeficiency Syndrome OR Human Immunodeficiency Virus OR chlamydia OR genital herpes OR gonorrhea OR pelvic inflammatory

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00001281
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : October 26, 2018
Washington Hospital Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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.

Condition or disease
HIV Infection

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 21, 1991

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

HIV-uninfected volunteers
HIV-infected volunteers

Primary Outcome Measures :
  1. The purpose of this protocol is to provide a mechanism to obtain blood products and other biologic samples that will be used by NIH Intramural Investigators in studies of HIV and related diseases. [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. To provide the opportunity to compare genomic and proteomic properties of specimens obtained from individuals with HIV and other immunodeficiencies with those of healthy volunteers. [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV-uninfected and HIV-infected volunteers
  • 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, platelets greater than or equal to 50,000; HIV negative volunteers: hemoglobin greater than or equal to 9.0 g/dL, platelets greater than or equal to 50,000)
  • Be willing and able to provide written informed consent on screening and every 5 years, comply with study requirements and procedures, and comply with clinic policies
  • 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


  • Pregnant and/or breastfeeding females.
  • Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001281

Contact: Catherine A Seamon, R.N. (301) 402-3481
Contact: Susan Moir, Ph.D. (301) 402-4559

United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Christian Woods, M.D.    Not Listed   
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Washington Hospital Center
Principal Investigator: Susan Moir, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001281     History of Changes
Other Study ID Numbers: 910140
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 23, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Mononuclear Cells

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Slow Virus Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases