NCT00110578

Brief Summary

Effective, suppressive treatment for HIV infected patients can be a major challenge because HIV progressively destroys their immune systems. CD8 cells isolated from a patient's blood and grown in large numbers in the laboratory may increase a patient's immune system response to HIV. The purpose of this study is to determine if CD8 cells will provide effective antiviral activity against HIV when transplanted back in large numbers into HIV infected patients. Study hypothesis: There are specific cells in the immune system that recognize and can kill HIV-infected cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2005

Completed
Last Updated

August 8, 2008

Status Verified

July 1, 2007

First QC Date

May 10, 2005

Last Update Submit

August 7, 2008

Conditions

HIV Infections

Keywords

Treatment NaiveTreatment Experienced

Outcome Measures

Primary Outcomes (2)

  • To determine the safety of administering CD8+ HIV-specific CTL clones followed by subcutaneous IL-2 (Proleukin, Chiron) daily for up to 21 days

  • To identify a regimen of IL-2 that will improve the in vivo persistence and function of adoptively transferred CD8+ HIV-specific CTL

Secondary Outcomes (2)

  • To determine whether the administration of IL-2 prolongs the antiviral activity of transferred CD8+ HIV-specific CTL

  • To determine if IL-2 promotes the accumulation of adoptively transferred CD8+ HIV-specific CTL in lymph nodes

Interventions

Adoptive transfer of HIV-specific CD8+ T cellsPROCEDURE
AldesleukinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • CD4 count greater than 200 cells/mm3 at study entry
  • Absolute neutrophil count greater than 1000 cells/mm3
  • Willing to take Pneumocystis prophylaxis, if indicated
  • Willing to comply with study requirements
  • Willing to forgo other experimental therapy during the 26-week study period
  • Willing to use acceptable forms of contraception
  • Currently receiving treatment with an FDA-approved or expanded access antiretroviral agent (or combinations thereof) at a stable dose for at least 24 weeks prior to study entry
  • Have not received antiretroviral therapy for 6 months prior to study entry

You may not qualify if:

  • Treatment with other immunomodulatory therapies (interferon, HIV vaccines, intravenous immunoglobulin), pentoxifylline, cancer chemotherapy, radiation therapy, or other investigational agents
  • Past or present infection with mycobacterium avium complex, toxoplasmosis, cryptococcus, or cytomegalovirus (including retinitis)
  • Active opportunistic infection at study entry or serious systemic infection requiring chronic maintenance or suppressive therapy
  • Lymphoma, symptomatic visceral Kaposi's sarcoma, or any malignancy expected to require systemic therapy
  • Serious psychological or emotional disorder that would affect ability to comply with study requirements or that would be exacerbated by protocol participation
  • Alcohol or drug use, abuse, or dependence that, in the opinion of the investigator, would interfere with the study
  • Estimated life expectancy of less than 4 months
  • Abnormal neurocognitive examination
  • Significant abnormality on electrocardiogram or chest radiograph
  • Inability to generate CD8+ HIV-specific cytotoxic T cell clones
  • Previously treated in FHCRC Protocol #827.1
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

University of Washington (UW)

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • Chapuis AG, Casper C, Kuntz S, Zhu J, Tjernlund A, Diem K, Turtle CJ, Cigal ML, Velez R, Riddell S, Corey L, Greenberg PD. HIV-specific CD8+ T cells from HIV+ individuals receiving HAART can be expanded ex vivo to augment systemic and mucosal immunity in vivo. Blood. 2011 May 19;117(20):5391-402. doi: 10.1182/blood-2010-11-320226. Epub 2011 Mar 21.

    PMID: 21422474DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Stanley Riddell, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

May 10, 2005

First Posted

May 11, 2005

Study Start

September 1, 1998

Study Completion

April 1, 2005

Last Updated

August 8, 2008

Record last verified: 2007-07

Locations

US(2)