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

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.