Suspended

A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 Cells/mm3

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What is being tested

Allogenic Dendritic Cells

Drug
Who is being recruted

HIV Infections

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: December 14, 2016
Sourced from a government-validated database.Claim as a partner

To define the safety and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in increasing the immune response in HIV-infected patients. Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus. Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus. Dendritic cells from an HIV-negative sibling are obtained and treated with various viral proteins (HIV vaccines) or immunomodulators. The treated dendritic cells are infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.

Official TitleA Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 Cells/mm3 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: December 14, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Patients must have: * HLA A2+. * Same cell type as donor sibling. * CD4 count \> 350 cells/mm3. * HIV asymptomatic status. * No HIV antivirals during study. * Normal labs and chest x-ray. Donor siblings must have: * HLA A2+. * HIV negativity. * Ability to donate cells on multiple occasions. * Negative status for hepatitis B and C. Exclusion Criteria Concurrent Medication: Excluded: * Antiviral therapy (unless CD4 count declines to \< 350 cells/mm3). Prior Medication: Excluded: * Antiviral therapy within 90 days prior to study entry.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Stanford Univ School of MedicineStanford, United StatesSee the location
SuspendedOne Study Center