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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00000824
Other study ID # SPIRAT 2
Secondary ID
Status Terminated
Phase N/A
First received November 2, 1999
Last updated December 13, 2016
Est. completion date June 2005

Study information

Verified date April 1995
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lymphocytes, Activated


Locations

Country Name City State
United States Stanford Univ School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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