A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/15/2016 |
| End Date: | June 2005 |
A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3
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.
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.
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.
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.
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.
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