Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
91 participants
INTERVENTIONAL
2005-08-31
2007-08-31
Brief Summary
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A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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HIV-1 gag DNA (formulated with bupivacaine)
IL-15 DNA (formulated with bupivacaine)
IL-12 DNA (formulated with bupivacaine)
Sodium chloride injection USP (0.9%)
Eligibility Criteria
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Inclusion Criteria
* Receiving stable HAART for a minimum of 6 consecutive months immediately before screening.
* CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4 T-cell count less than 250 mm cubed/mL at any time before screening.
Other Inclusions Apply
Exclusion Criteria
* History of diagnosed autoimmune disease (currently active or under control).
* Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening (documented, unblinded placebo recipients from previous clinical trials may participate without this time restriction).
Other Exclusions Apply
18 Years
50 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor, MD
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Birmingham, Alabama, United States
Denver, Colorado, United States
Orlando, Florida, United States
Boston, Massachusetts, United States
Austin, Texas, United States
Dallas, Texas, United States
Berlin, , Germany
Cologne, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
München, , Germany
Stockholm, , Sweden
Countries
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Other Identifiers
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6120K1-100
Identifier Type: -
Identifier Source: org_study_id