Back to resultsStudy Evaluating Vaccine in Adults With HIV
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
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%)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Vaccine, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: Must be HIV positive. 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: Any chronic symptomatic infection other than HIV. 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
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART
intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
Secondary Outcome Measures
Full Information
NCT ID
NCT00195312
First Posted
August 5, 2005
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195312
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-1 Gag DNA Vaccine Administered Alone or With Escalating Doses of IL-12 DNA or IL-15 DNA Molecular Adjuvants to HIV-1 Positive Adults Receiving Stable HAART.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 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 main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Vaccine, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
91 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
HIV-1 gag DNA (formulated with bupivacaine)
Intervention Type
Biological
Intervention Name(s)
IL-15 DNA (formulated with bupivacaine)
Intervention Type
Biological
Intervention Name(s)
IL-12 DNA (formulated with bupivacaine)
Intervention Type
Biological
Intervention Name(s)
Sodium chloride injection USP (0.9%)
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART
Title
intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
Title
intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be HIV positive.
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:
Any chronic symptomatic infection other than HIV.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Germany, MedinfoDEU@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Sweden, MedInfoNord@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Berlin
ZIP/Postal Code
12157
Country
Germany
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
München
ZIP/Postal Code
80336
Country
Germany
City
Stockholm
ZIP/Postal Code
118 23
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Vaccine in Adults With HIV
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