NCT00067795

Brief Summary

Some people's immune systems are able to control HIV infection without anti-HIV drugs. Other people with HIV must take drugs to prevent the virus from destroying their immune systems. There are many different laboratory tests that measure immune function in people with HIV. This study will compare some of these tests to see if they consistently measure differences between people who control the HIV without anti-HIV drugs and those who must take drugs.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

6 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

August 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2003

Completed
Last Updated

November 22, 2010

Status Verified

November 1, 2010

First QC Date

August 27, 2003

Last Update Submit

November 19, 2010

Conditions

HIV Infections

Keywords

Treatment ExperiencedAntiretroviral Therapy, Highly ActiveHIV AntigensCohort StudiesImmunity, CellularT-Lymphocytes

Eligibility Criteria

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

You may qualify if:

  • HIV-1 infection
  • CD4 cell count \> 300 cells/mm3 within 60 days prior to study entry
  • Negative pregnancy test within 14 days of starting study
  • Agree to use acceptable methods of contraception while in study
  • Stable HAART regimen, defined as the suppression of viral load to undetectable levels, for at least 9 months prior to study entry
  • Viral load \< 75 copies/ml on at least three occasions within 9 months prior to study entry, with at least one of these values obtained between 6 and 9 months prior to study entry
  • No single viral load \>= 75 copies/ml within 9 months prior to study entry
  • Not taking any antiretroviral drugs for at least 6 months prior to study entry
  • Meets study definition of efficient immune control (generally HIV-1 viral load \< 3,000 copies/ml, with some exceptions)

You may not qualify if:

  • Pregnancy or breast-feeding
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  • History of an AIDS-defining opportunistic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35924-2050, United States

Location

UC Davis Medical Center

Sacremento, California, 95814, United States

Location

University of Miami

Miami, Florida, 33136-1013, United States

Location

Rush-Presbyterian/St. Lukes

Chicago, Illinois, 60612-3806, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106-5083, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Related Publications (4)

  • Bucy RP, Kilby JM. Perspectives on inducing efficient immune control of HIV-1 replication--a new goal for HIV therapeutics? AIDS. 2001 Feb;15 Suppl 2:S36-42. doi: 10.1097/00002030-200102002-00007.

    PMID: 11424975BACKGROUND

  • Bucy RP. Immune clearance of HIV type 1 replication-active cells: a model of two patterns of steady state HIV infection. AIDS Res Hum Retroviruses. 1999 Feb 10;15(3):223-7. doi: 10.1089/088922299311394. No abstract available.

    PMID: 10052752BACKGROUND

  • Pantaleo G, Menzo S, Vaccarezza M, Graziosi C, Cohen OJ, Demarest JF, Montefiori D, Orenstein JM, Fox C, Schrager LK, et al. Studies in subjects with long-term nonprogressive human immunodeficiency virus infection. N Engl J Med. 1995 Jan 26;332(4):209-16. doi: 10.1056/NEJM199501263320402.

    PMID: 7808486BACKGROUND

  • Macatangay BJ, Zheng L, Rinaldo CR, Landay AL, Pollard RB, Pahwa S, Lederman MM, Bucy RP. Comparison of immunologic assays for detecting immune responses in HIV immunotherapeutic studies: AIDS Clinical Trials Group Trial A5181. Clin Vaccine Immunol. 2010 Sep;17(9):1452-9. doi: 10.1128/CVI.00498-09. Epub 2010 Jul 14.

    PMID: 20631337RESULT

MeSH Terms

Conditions

HIV Infections

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

  • R. Pat Bucy, MD, PhD

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 27, 2003

First Posted

August 28, 2003

Last Updated

November 22, 2010

Record last verified: 2010-11

Locations

US(6)