Study Evaluating Vaccine in Adults With HIV

NCT ID: NCT00195312

Last Updated: 2007-12-05

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV Vaccine Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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HIV-1 gag DNA (formulated with bupivacaine)

Intervention Type BIOLOGICAL

IL-15 DNA (formulated with bupivacaine)

Intervention Type BIOLOGICAL

IL-12 DNA (formulated with bupivacaine)

Intervention Type BIOLOGICAL

Sodium chloride injection USP (0.9%)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Sweden, [email protected]

Locations

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Birmingham, Alabama, United States

Site Status

Denver, Colorado, United States

Site Status

Orlando, Florida, United States

Site Status

Boston, Massachusetts, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Berlin, , Germany

Site Status

Cologne, , Germany

Site Status

Frankfurt, , Germany

Site Status

Hamburg, , Germany

Site Status

Hanover, , Germany

Site Status

München, , Germany

Site Status

Stockholm, , Sweden

Site Status

Countries

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United States Germany Sweden

Other Identifiers

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6120K1-100

Identifier Type: -

Identifier Source: org_study_id