Overview

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

Status:
Terminated
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
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.