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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00026624 |
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Date of registration:
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12/11/2001 |
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Primary sponsor: |
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Public title:
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Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC
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Scientific title:
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A Phase I/II Study to Evaluate the Safety and Immunogenicity of the Subcutaneous Administration of ALVAC-HIV vCP1452 Infected Autologous Dendritic Cells Versus the Subcutaneous Administration of ALVAC-HIV vCP1452 To HIV-Infected Subjects |
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Date of first enrolment:
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October 2001 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00026624 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeffrey Jacobson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-infected.
- Took 3 or more anti-HIV drugs for 3 or more months before study entry.
- Have a viral load of 400 copies/ml or less for a period of 3 months before study
start and within 30 days before study start.
- Have a CD4 count of 400 cells/mm3 or more for a period of 3 months before study start
and within 30 days before study start.
- Have a CD4 count of 400 cells/mm3 or more at study screening.
- Have a viral load of 50 copies/ml or less at study screening.
- Are at least 18 years old.
- Agree not to become pregnant or to impregnate during the study and for 12 weeks after
the study, if able to have children.
Exclusion Criteria
Patients may not be eligible for this study if they:
- Have a short-term but intense infection or serious illness within 14 days before
study start and have not completed therapy or are not clinically stable on therapy.
- Have viral load values greater than 400 copies/ml within 3 months before study start.
- Have CD4 counts less than 400 cells/mm3 within 3 months before study start.
- Have close contact with canaries through work (e.g., breeding farms, bird shops).
Does not apply to pet canaries.
- Are allergic to eggs or neomycin. Have a history of serious allergic reactions
including allergy-induced asthma.
- Are sensitive or allergic to study drugs.
- Use drugs or alcohol in a way that would interfere with the patients' ability to
follow the study requirements.
- Have become HIV-positive within 1 year before study start.
- Are pregnant or breast-feeding.
- Have had lymph node irradiation.
- Have had any HIV vaccine.
- Have used hydroxyurea within 45 days of study start.
- Have received drugs that affect the immune system, such as corticosteriods, within 30
days before study start.
- Are allergic to shellfish. (This study has been changed to make shellfish allergy an
exclusion criterion and to remove abacavir use as an exclusion criterion.)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Biological: ALVAC(2)120(B,MN)GNP (vCP1452)
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Drug: Keyhole-Limpet Hemocyanin
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Secondary ID(s)
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10080
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A5130
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AACTG A5130
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ACTG A5130
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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