Terminated

Phase Not Applicable
Age: 18Years +
All Genders
ID00000824

A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2016-12-14

N/A

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

To define the safety of cytotoxic T lymphocytes (CTLs) generated from sibling-supplied dendritic cells and lymphocytes and infused into an HIV-infected patient. To determine the efficacy of these CTLs in helping the immune system to fight HIV. With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus.

CONDITIONS

Official Title

A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Patients must have:

  • HLA A2+.
  • Other HLA matching with sibling.
  • CD4 count 100-350 cells/mm3.
  • No active opportunistic infection or malignancy (other than cutaneous Kaposi's sarcoma).
  • Current stable antiviral regimen.
  • Normal lab values and chest x-ray.

Donor siblings must have:

  • HLA A2+.
  • HIV negativity.
  • Good venous access.
  • Ability to donate on multiple occasions.
  • Negative status for hepatitis B and C.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Immunomodulators.
  • Cytokines.
  • Systemic steroids.
  • IV pentamidine.
  • Investigational drugs.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

Stanford Univ School of Medicine

Stanford, California, United States, 943055107

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3 | DecenTrialz