NCT00014053

Brief Summary

The purpose of this study is to compare immune system activity in young people and older people who do not have HIV. This information will be compared to that of HIV patients in another study. Aging affects immune system activity. This study will look at some of the factors involved. HIV also affects immune system activity. The results from this study, using healthy volunteers, will be compared to those in another study of HIV-infected patients. This may provide information on immune system activity in aging and HIV.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2001

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

July 30, 2008

Status Verified

June 1, 2003

First QC Date

April 10, 2001

Last Update Submit

July 29, 2008

Conditions

Keywords

Reference ValuesHIV SeropositivityImmune SystemCD4-Positive T-LymphocytesHIV SeronegativityAntigens, CD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers may be eligible for this study if they:
  • Are willing to undergo HIV testing.
  • Have a negative urine or serum pregnancy test within 30 days prior to study entry (for women volunteers).
  • Are between the ages of 18 and 30 or are 45 or older.

You may not qualify if:

  • Volunteers will not be eligible for this study if they:
  • Have HIV infection.
  • Have a serious infection or other serious medical illness that requires treatment and/or hospitalization within 90 days before study entry.
  • Have had cancer.
  • Have received any of the following within 6 months of study entry: systemic corticosteroids; chemotherapy or radiation; erythropoietin, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or growth hormone; drugs that affect the immune system including thalidomide, interleukins, interferons, or other cytokines; anabolic steroids at high levels; or any experimental agent, unless allowed otherwise by the researchers.
  • Are immune to hepatitis A.
  • Have received tetanus toxoid within 5 years prior to study entry or have a history of severe reaction to tetanus vaccine at any time in the past.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Univ of California San Francisco

San Francisco, California, 94110, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Washington Univ School of Medicine

St Louis, Missouri, 63108, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

Univ of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Tenorio AR, Spritzler J, Martinson J, Gichinga CN, Pollard RB, Lederman MM, Kalayjian RC, Landay AL. The effect of aging on T-regulatory cell frequency in HIV infection. Clin Immunol. 2009 Mar;130(3):298-303. doi: 10.1016/j.clim.2008.10.001. Epub 2008 Nov 12.

MeSH Terms

Conditions

HIV InfectionsHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Robert Kalayjian

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 10, 2001

First Posted

August 31, 2001

Last Updated

July 30, 2008

Record last verified: 2003-06

Locations