- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00856154
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection (HIVDCVac)
April 7, 2009 updated by: Statens Serum Institut
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection. Phase I Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, DK-2100
- Rigshospitalet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cellular Immunity induction
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Anders Fomsgaard, MD DMSc, Statens Serum Institut
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
March 4, 2009
First Posted (Estimate)
March 5, 2009
Study Record Updates
Last Update Posted (Estimate)
April 8, 2009
Last Update Submitted That Met QC Criteria
April 7, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- EudraCT2006-000102-22
- EudraCT 2006-000102-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Peptides on autologous Dendritic Cells
-
Sara VareaCompletedMultiple Sclerosis | Neuromyelitis OpticaSpain
-
The Republican Research and Practical Center for...Belarusian State Medical UniversityCompletedPancreatic Neoplasms | Dendritic CellsBelarus
-
Fundació Sant Joan de DéuInstitut d'Investigacions Biomèdiques August Pi i SunyerUnknownDiffuse Intrinsic Pontine GliomaSpain
-
Ever Supreme Bio Technology Co., Ltd.Recruiting
-
Jonsson Comprehensive Cancer CenterKite, A Gilead CompanyCompletedClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
Massachusetts General HospitalNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV Infections | HIV-1 InfectionUnited States
-
Radboud University Medical CenterRotterdam Eye HospitalTerminated
-
The Catholic University of KoreaRecruitingMyocardial InfarctionKorea, Republic of
-
Clinica Universidad de Navarra, Universidad de...CompletedGlioblastoma MultiformeSpain
-
Cedars-Sinai Medical CenterCompletedGlioblastoma | Brain Stem GliomaUnited States