Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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).


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

P01AI43664-04


NCT ID:

NCT00056758


Secondary ID:

P01 AI43664-04


Study Acronym:


Brief Title:

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


Official Title:

Randomized Phase I Evaluation of Immunization With Highly Conserved HIV-1 Derived Peptides and Influenza Matrix Peptide in HIV-1-Infected Subjects on Highly Active Antiretroviral Therapy (HAART) Using Autologous Dendritic Cells Derived From Adherent Monoc


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:


Overall Contact Information

Official Name:Sharon A. Riddler, MD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:February 2003
Verification Date:August 2007
Last Changed Date:August 23, 2007
First Received Date:March 21, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety and tolerability of peptide pulsed, autologous, cultured dendritic cells
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:Autologous Dendritic Cell HIV Vaccination

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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