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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: |
NCT00000832 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers
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Scientific title:
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A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers |
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Date of first enrolment:
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November 1994 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00000832 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention
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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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Corey L |
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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
Volunteers must have:
- Normal history and physical exam.
- HIV negativity.
- Absolute CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
- Lower risk sexual behavior.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition (such as recent suicidal ideation or present
psychosis) that precludes compliance.
- Active syphilis. NOTE: Subjects with serology documented to be a false positive or
due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray
showing no evidence of TB and not requiring isoniazid therapy are eligible.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of
immunosuppressive medications.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of serious allergic reaction to any substance, requiring hospitalization or
emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior psychiatric condition (such as history of suicide attempts or past psychosis)
that precludes compliance.
- History of cancer unless there has been surgical excision that is considered to have
achieved cure.
Prior Medication:
Excluded:
- Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically
indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude
if administered at least 2 weeks from HIV immunizations.
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
Prior Treatment:
Excluded:
- Blood products or immunoglobulin within the past 6 months.
Identifiable high-risk behavior for HIV infection, including:
- History of injection drug use within past 12 months.
- Higher risk sexual behavior.
Age minimum:
18 Years
Age maximum:
60 Years
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: MF59
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Biological: rgp120/HIV-1 SF-2
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Secondary ID(s)
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10575
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AVEG 024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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