NCT00407836

Brief Summary

The hallmark of HIV infection and AIDS is the continuous attrition of CD4 T cells. One of the mechanisms that may account for the CD4 attrition , is autoimmunity against the CD4 T cells, caused by autologous immune cells. Vaccination against autoimmune reactive T cells has been successfully tried in animal models of autoimmune diseases and is now being tried in patients with Multiple Sclerosis. The purpose of the present study is to test this hypothesis in HIV infection. We will vaccinate HIV infected patients in whom specific autoimmune reactivity against CD4 is present , with their own CD4 reactive T cells. Following that, we shall study the patients and find out if the T cell vaccination caused a rise in CD4 T cell levels, and whether it influenced HIV viral load, as well as HIV and CD4 specific immunity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 2, 2009

Status Verified

November 1, 2006

Enrollment Period

2 years

First QC Date

December 3, 2006

Last Update Submit

December 1, 2009

Conditions

HIV Infections

Keywords

HIVCD4 T cell levelCD4 autoimmunityViral loadT cell vaccinationHIV Therapeutic Vaccine

Outcome Measures

Primary Outcomes (3)

  • CD4 T cell levels

    one year follow up

  • HIV plasma viral load

    one year follow up

  • Clinical HIV infection

    one year follow up

Secondary Outcomes (3)

  • HIV specific immune responses

    One year follow up

  • CD4 specific responses

    One year follow up

  • Immune profile

    One year follow up

Study Arms (1)

Vaccination

EXPERIMENTAL

One arm of open label T cell vaccination in which all participants will receive the T cell vaccine

Biological: T cell vaccination

Interventions

T cell vaccinationBIOLOGICAL

Approximately 10-20 million glutaraldehyde fixed CD4 responsive autologous T cells in 1-2 ml, per vaccine injection.

Vaccination

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CD4 cell counts -from 150 to 450/mm3 and stable for at least 12 months, and treatment with HAART for at least 6 months.
  • Positive cell proliferation assay to CD4 molecule
  • Low HIV viral load (\<400 - 5000 copies/ml) for at least 12 months
  • No change of antiretroviral treatment for at least 6 months
  • Signed informed consent

You may not qualify if:

  • Concomitant immunosuppressive or antineoplastic treatment as well as chronic systemic glucocorticoid therapy.
  • Pregnancy and women without any efficacious contraception.
  • Clinically relevant liver disease (AST and/or ALT \>2,5x upper limit of normal range, or total bilirubin \> 3,5 mg/dl).
  • Serum creatinine \>1,8mg/dl or creatinine clearance \<30ml/min.
  • Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

Location

Related Publications (2)

  • Abulafia-Lapid R, Bentwich Z, Keren-Zur Y, Cohen IR, Atlan H. T-cell vaccination against anti-CD4 autoimmunity in HIV-1 infected patients. J Clin Virol. 2004 Dec;31 Suppl 1:S48-54. doi: 10.1016/j.jcv.2004.09.017.

    PMID: 15567094RESULT

  • Abulafia-Lapid R, Mayan S, Bentwich Z, Keren-Zur Y, Avbramovitz Y, Cohen IR, Atlan H. T-cell vaccination against anti-CD4 autoimmunity in HIV-1 subtypes B and C-infected patients--an extended open trial. Vaccine. 2005 Mar 18;23(17-18):2149-53. doi: 10.1016/j.vaccine.2005.01.054.

    PMID: 15755585RESULT

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

  • Klaris Riesenberg, M.D.

    Soroka U Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2006

First Posted

December 5, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 2, 2009

Record last verified: 2006-11

Locations

IL(1)