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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000824

Enrollment

Unknown

Registered

2001-08-31

Start date

Unknown

Completion date

2005-06-30

Last updated

2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Immunotherapy, Adoptive, T-Lymphocyte Subsets, T-Lymphocytes, Cytotoxic, Dendritic Cells

Brief 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.

Detailed 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.

Interventions

DRUGLymphocytes, Activated

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026