Study Evaluating Vaccine in Adults With HIV

NCT ID: NCT00195234

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV 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 CTL MEP 1000 micrograms, 19 months per subject

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 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

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Sacramento, California, United States

Site Status

Denver, Colorado, United States

Site Status

Chicago, Illinois, United States

Site Status

New York, New York, United States

Site Status

Cleveland, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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6112K2-100

Identifier Type: -

Identifier Source: org_study_id