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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-000102-22 |
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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular Immunity induction | 12 months |
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| Name | Affiliation | Role |
|---|---|---|
| Anders Fomsgaard, MD DMSc | Statens Serum Institut | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17550385 | Background | Thorn M, Tang S, Therrien D, Kloverpris H, Vinner L, Kronborg G, Gerstoft J, Corbet S, Fomsgaard A. Sequence conservation of subdominant HLA-A2-binding CTL epitopes in HIV-1 clinical isolates and CD8+ T-lymphocyte cross-recognition may explain the immune reaction in infected individuals. APMIS. 2007 Jun;115(6):757-68. doi: 10.1111/j.1600-0463.2007.apm_595.x. |
| Label | URL |
|---|---|
| Danish Medicines Agency | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Danish register of persons in projects | View source |
| Statens Serum Institut in Denmark (government institution) | View source |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |