NCT00856154|CompletedPhase 1DMC
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection
HIVDCVac
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Sponsor study identifier
Secondary identifiers
interventional
12
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
October 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
April 2008
Actual (reported)October 2008
Actual (reported)March 3, 2009
Actual (reported)March 5, 2009
Actual (reported)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
Cellular Immunity induction
12 months
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rigshospitalet
Copenhagen, DK-2100, Denmark
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.
Anders Fomsgaard, MD DMSc
Statens Serum Institut
12 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2009
First Posted
March 5, 2009
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals
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Primary Completion
April 2008
Actual (reported)Study Completion
October 2008
Actual (reported)Last Updated
April 8, 2009
Record last verified: 2009-03
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Source: ClinicalTrials.gov.
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