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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000824

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Lymphocytes, Activated

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000824

Locations

United States, California
Stanford Univ School of Medicine
Stanford, California, United States, 943055107

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

No publications provided

Study ID Numbers:	SPIRAT 2
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000824 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 09, 2009