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

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Terminated

Conditions

HIV Infections

Treatments

Drug: Lymphocytes, Activated

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000824
SPIRAT 2

Details and patient eligibility

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.

Full description

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. Dendritic cells and lymphocytes are obtained from an HIV-negative sibling. HIV-specific CTLs are generated from these cells and then 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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