Back to resultsStudy Evaluating Vaccine in Adults With HIV
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HIV CTL MEP 1000 micrograms, 19 months per subject
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
Full Information
NCT ID
NCT00195234
First Posted
September 12, 2005
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195234
Brief Title
Study Evaluating Vaccine in Adults With HIV
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
HIV CTL MEP 1000 micrograms, 19 months per subject
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5083
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2582
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Vaccine in Adults With HIV
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