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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00000824
• Other study ID #: SPIRAT 2
• 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

• HIV Infections

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,