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



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

For Condition: HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

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


Additional Information:
Study ID Numbers:  SPIRAT 2; 
Study Start Date: 
Record last reviewed: April 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000824

Other Hiv Infections Studies:
1. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers

2. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

3. Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials

4. An HIV Vaccine Preparedness Study

5. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

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