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HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs

NCT ID: NCT00056758

Last Updated: 2007-08-27

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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This study will evaluate the safety of and immune responses to a dendritic cell vaccination for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).

Detailed Description

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Untreated HIV-1 infection is characterized by progressive immune dysfunction and the development of opportunistic infections and AIDS-associated malignancies. Highly active antiretroviral therapy (HAART) has been successful in suppressing HIV replication and restoring partial immune function. However, HIV-specific immunity remains poor, as evidenced by rapid rebound of HIV-1 RNA following HAART withdrawal. Studies of individuals with acute HIV-1 infection, as well as those who are long-term nonprogressors, have suggested that robust HIV-specific immune responses are associated with control of HIV-1 viremia. Dendritic cells (DCs) are potent antigen presenting cells that may increase HIV-specific immune responses. This protocol will evaluate the use of DCs to help control HIV infection.

Patients will be randomized to receive either intravenous or subcutaneous administration of HIV antigen expressing DCs. Each subject will receive two administrations of mature DCs given 3 weeks apart. Subjects will be followed weekly for 8 weeks, then at Weeks 12, 16, 24, 36, and 48. Two doses of DCs will be evaluated (low dose: 1-3 million cells; high dose: 5-10 million cells) for safety and immune system response.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous Dendritic Cell HIV Vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infection
* Current CD4 count more than 400/mm3
* HIV RNA less than 400 copies/ml
* Stable combination antiretroviral therapy for at least 4 weeks prior to study entry
* HLA A2.1 (to be tested at screening)

Exclusion Criteria

* Prior HIV vaccine
* Systemic steroids or immunosuppressive drugs within 30 days of study entry
* Pregnant or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Sharon A. Riddler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh, Pitt Treatment Evaluation Unit

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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P01AI043664-04

Identifier Type: NIH

Identifier Source: secondary_id

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P01AI043664-04

Identifier Type: NIH

Identifier Source: org_study_id

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