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Completed

NCT Number: NCT00856154

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

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Treated with other experimental vaccines or immune modulatig medicine
  • Other chronic infectious diseases
  • Allergy or autoimmune disease

Treatment and study plan

Peptides on autologous Dendritic Cells

Biological

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

  • Gag150 RLLNAWVKV
  • Gag433 FLGKIWPV
  • Env 67 NIWATHACV
  • Pol606 KLGKAGYVV
  • Vpu66 ALVEMGHHV
  • Vif101 GLADQLIHL
  • Vif23 SLVKHHMYV
  • Gag298 KRWIILGLNKIVRMY
  • gp41 VWGIKQLQARVLAVERYLKD
  • Padre AKXVAAWTLKAAA

Other names: Dendritic Cells, HIV-1 Peptides

Primary outcomes

  1. Safety: no changes in the blood Hemoglobin, leucocytes, trombocytes, serum sodium,potassium,creatinine,phosphatase, ALAT,ASAT, bilirubin,CRP. No dose limiting toxicity defined as unwanted events defined by CTC version 3 definition as greade 3 or more.

    Time frame: 12 months

Secondary outcomes

  1. Cellular Immunity induction

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Collaborators

  • Hvidovre University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection. Phase I Trial

Acronym: HIVDCVac

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2009
Registry last updated
Apr 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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