Study Evaluating Vaccine in Adults With HIV
A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.
1 other identifier
interventional
60
1 country
10
Brief Summary
The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV. A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Dec 2004
Typical duration for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 5, 2007
December 1, 2007
September 12, 2005
December 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
Secondary Outcomes (1)
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
Interventions
Eligibility Criteria
You may qualify if:
- years of age diagnosed with HIV and on stable HAART for a minimum of six months
- CD4 T-cell count greater than and equal to 350/mm3 at screening
- No reported CD4 T-cell count less than 350/mm3 at any time before screening
- Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening
You may not qualify if:
- Any chronic symptomatic infection other than HIV
- Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
- Any malignancy that may require systemic therapy
- Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
Cleveland, Ohio, 44106-5083, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Nashville, Tennessee, 37232-2582, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Dallas, Texas, 75390-9103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
December 1, 2004
Study Completion
February 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12