NCT00068978

Brief Summary

This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2003

Completed
Last Updated

September 18, 2007

Status Verified

August 1, 2007

First QC Date

September 12, 2003

Last Update Submit

September 17, 2007

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Keywords

HIV SeronegativityHIV Preventive VaccineHIV Therapeutic Vaccine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Blood samples from 5 cohorts of HIV infected individuals and 2 cohorts of HIV uninfected individuals will be evaluated. Varying stages of HIV disease are represented in these cohorts, including: * Individuals who have been exposed but who have not seroconverted * Individuals who have recently seroconverted * HAART-treated patients who receive immune modulators such as IL-2 and therapeutic immunization * HAART-treated patients who undergo structured treatment interruptions * HAART-treated patients who have durable suppression of viremia * HAART-treated patients who experience incomplete suppression of viremia * HAART-treated patients followed with careful drug adherence monitoring * Long-term nonprogressors * Untreated progressors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Core Immunology Laboratory

San Francisco, California, 94103, United States

Location

Related Publications (16)

  • Jacobson MA, Schrier R, McCune JM, Torriani FJ, Holland GN, O'Donnell JJ, Freeman WR, Bredt BM. Cytomegalovirus (CMV)-specific CD4+ T lymphocyte immune function in long-term survivors of AIDS-related CMV end-organ disease who are receiving potent antiretroviral therapy. J Infect Dis. 2001 May 1;183(9):1399-404. doi: 10.1086/319854. Epub 2001 Mar 30.

    PMID: 11294673RESULT

  • Aberg JA, Price RW, Heeren DM, Bredt B. A pilot study of the discontinuation of antifungal therapy for disseminated cryptococcal disease in patients with acquired immunodeficiency syndrome, following immunologic response to antiretroviral therapy. J Infect Dis. 2002 Apr 15;185(8):1179-82. doi: 10.1086/339680. Epub 2002 Apr 1.

    PMID: 11930330RESULT

  • Bredt BM, Higuera-Alhino D, Shade SB, Hebert SJ, McCune JM, Abrams DI. Short-term effects of cannabinoids on immune phenotype and function in HIV-1-infected patients. J Clin Pharmacol. 2002 Nov;42(S1):82S-89S. doi: 10.1002/j.1552-4604.2002.tb06007.x.

    PMID: 12412840RESULT

  • Jacobson MA, Bredt BM. Association of cytomegalovirus (CMV)-specific CD4+ T lymphocyte reactivity and protective immunity against acquired immunodeficiency syndrome-related CMV retinitis. J Infect Dis. 2002 Dec 1;186(11):1701-2; author reply 1702-3. doi: 10.1086/345369. No abstract available.

    PMID: 12447752RESULT

  • Hunt PW, Martin JN, Sinclair E, Bredt B, Hagos E, Lampiris H, Deeks SG. T cell activation is associated with lower CD4+ T cell gains in human immunodeficiency virus-infected patients with sustained viral suppression during antiretroviral therapy. J Infect Dis. 2003 May 15;187(10):1534-43. doi: 10.1086/374786. Epub 2003 Apr 23.

    PMID: 12721933RESULT

  • Abrams DI, Hilton JF, Leiser RJ, Shade SB, Elbeik TA, Aweeka FT, Benowitz NL, Bredt BM, Kosel B, Aberg JA, Deeks SG, Mitchell TF, Mulligan K, Bacchetti P, McCune JM, Schambelan M. Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized, placebo-controlled clinical trial. Ann Intern Med. 2003 Aug 19;139(4):258-66. doi: 10.7326/0003-4819-139-4-200308190-00008.

    PMID: 12965981RESULT

  • Suni MA, Dunn HS, Orr PL, de Laat R, Sinclair E, Ghanekar SA, Bredt BM, Dunne JF, Maino VC, Maecker HT. Performance of plate-based cytokine flow cytometry with automated data analysis. BMC Immunol. 2003 Sep 2;4:9. doi: 10.1186/1471-2172-4-9. Epub 2003 Sep 2.

    PMID: 12952557RESULT

  • Karlsson AC, Martin JN, Younger SR, Bredt BM, Epling L, Ronquillo R, Varma A, Deeks SG, McCune JM, Nixon DF, Sinclair E. Comparison of the ELISPOT and cytokine flow cytometry assays for the enumeration of antigen-specific T cells. J Immunol Methods. 2003 Dec;283(1-2):141-53. doi: 10.1016/j.jim.2003.09.001.

    PMID: 14659906RESULT

  • Deeks SG, Martin JN, Sinclair E, Harris J, Neilands TB, Maecker HT, Hagos E, Wrin T, Petropoulos CJ, Bredt B, McCune JM. Strong cell-mediated immune responses are associated with the maintenance of low-level viremia in antiretroviral-treated individuals with drug-resistant human immunodeficiency virus type 1. J Infect Dis. 2004 Jan 15;189(2):312-21. doi: 10.1086/380098. Epub 2004 Jan 7.

    PMID: 14722897RESULT

  • Jacobson MA, Maecker HT, Orr PL, D'Amico R, Van Natta M, Li XD, Pollard RB, Bredt BM; Adult AIDS Clinical Trials Group and the Studies of Ocular Complications of AIDS Research Group. Results of a cytomegalovirus (CMV)-specific CD8+/interferon- gamma+ cytokine flow cytometry assay correlate with clinical evidence of protective immunity in patients with AIDS with CMV retinitis. J Infect Dis. 2004 Apr 15;189(8):1362-73. doi: 10.1086/382964. Epub 2004 Mar 31.

    PMID: 15073672RESULT

  • Karlsson AC, Younger SR, Martin JN, Grossman Z, Sinclair E, Hunt PW, Hagos E, Nixon DF, Deeks SG. Immunologic and virologic evolution during periods of intermittent and persistent low-level viremia. AIDS. 2004 Apr 30;18(7):981-9. doi: 10.1097/00002030-200404300-00005.

    PMID: 15096800RESULT

  • Sinclair E, Black D, Epling CL, Carvidi A, Josefowicz SZ, Bredt BM, Jacobson MA. CMV antigen-specific CD4+ and CD8+ T cell IFNgamma expression and proliferation responses in healthy CMV-seropositive individuals. Viral Immunol. 2004;17(3):445-54. doi: 10.1089/vim.2004.17.445.

    PMID: 15357911RESULT

  • Neuenburg JK, Sinclair E, Nilsson A, Kreis C, Bacchetti P, Price RW, Grant RM. HIV-producing T cells in cerebrospinal fluid. J Acquir Immune Defic Syndr. 2004 Oct 1;37(2):1237-44. doi: 10.1097/01.qai.0000136733.09275.fa.

    PMID: 15385730RESULT

  • Maecker HT, Rinfret A, D'Souza P, Darden J, Roig E, Landry C, Hayes P, Birungi J, Anzala O, Garcia M, Harari A, Frank I, Baydo R, Baker M, Holbrook J, Ottinger J, Lamoreaux L, Epling CL, Sinclair E, Suni MA, Punt K, Calarota S, El-Bahi S, Alter G, Maila H, Kuta E, Cox J, Gray C, Altfeld M, Nougarede N, Boyer J, Tussey L, Tobery T, Bredt B, Roederer M, Koup R, Maino VC, Weinhold K, Pantaleo G, Gilmour J, Horton H, Sekaly RP. Standardization of cytokine flow cytometry assays. BMC Immunol. 2005 Jun 24;6:13. doi: 10.1186/1471-2172-6-13.

    PMID: 15978127RESULT

  • Emu B, Sinclair E, Favre D, Moretto WJ, Hsue P, Hoh R, Martin JN, Nixon DF, McCune JM, Deeks SG. Phenotypic, functional, and kinetic parameters associated with apparent T-cell control of human immunodeficiency virus replication in individuals with and without antiretroviral treatment. J Virol. 2005 Nov;79(22):14169-78. doi: 10.1128/JVI.79.22.14169-14178.2005.

    PMID: 16254352RESULT

  • Jacobson MA, Sinclair E, Bredt B, Agrillo L, Black D, Epling CL, Carvidi A, Ho T, Bains R, Adler SP. Antigen-specific T cell responses induced by Towne cytomegalovirus (CMV) vaccine in CMV-seronegative vaccine recipients. J Clin Virol. 2006 Mar;35(3):332-7. doi: 10.1016/j.jcv.2005.09.019. Epub 2006 Jan 18.

    PMID: 16387547RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Joseph M. McCune, MD, PhD

    University of California at San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 12, 2003

First Posted

September 16, 2003

Study Start

April 1, 2003

Last Updated

September 18, 2007

Record last verified: 2007-08

Locations

US(1)