Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-10-31

Brief Summary

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Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated HIV-1 infection the investigators have identified relatively immune silent immune subdominant HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about 50% of peoples in Denmark). Immunising with these conserved epitopes could induce new immunity and lower viral load so the patient will live longer before AIDS or Antiviral medicine and a lower viral load will limit spread in the population. As adjuvants the investigators used patients' own autologous Dendritic Cells generated from blood cells in vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4 T-cell immunity.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Peptides on autologous Dendritic Cells

10 Peptides Pulsed onto 10e7 autologous macrophage-derived maturated dendritic cells administered s.c. week 0, 2, 4, 8.

1. Gag150 RLLNAWVKV
2. Gag433 FLGKIWPV
3. Env 67 NIWATHACV
4. Pol606 KLGKAGYVV
5. Vpu66 ALVEMGHHV
6. Vif101 GLADQLIHL
7. Vif23 SLVKHHMYV
8. Gag298 KRWIILGLNKIVRMY
9. gp41 VWGIKQLQARVLAVERYLKD
10. Padre AKXVAAWTLKAAA

Intervention Type BIOLOGICAL

Other Intervention Names

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Dendritic Cells HIV-1 Peptides

Eligibility Criteria

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Inclusion Criteria

* HIV positive male
* Viral load \>1000/ml
* CD4 count \>300
* HLA-A2 tissue type
* 18-50 years of age
* Able to follow the instructions
* Informed consent