Back to resultsA Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lymphocytes, Activated
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Immunotherapy, Adoptive, T-Lymphocyte Subsets, T-Lymphocytes, Cytotoxic, Dendritic Cells
Eligibility 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.
Sites / Locations
- Stanford Univ School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000824
First Posted
November 2, 1999
Last Updated
December 13, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000824
Brief Title
A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 1995
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Immunotherapy, Adoptive, T-Lymphocyte Subsets, T-Lymphocytes, Cytotoxic, Dendritic Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lymphocytes, Activated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Stanford Univ School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
12. IPD Sharing Statement
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A Study of Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients
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