A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC
2 other identifiers
interventional
6
1 country
1
Brief Summary
1\) To determine whether it is possible to remove and culture (increase in number and activate) in the laboratory, CD8(+) lymphocytes (white blood cells) from HIV-infected patients receiving zidovudine (AZT); 2) To determine the toxicity of returning to the patients intravenously the expanded and activated autologous cells (given to the patient from whom they were taken), with and without giving the patients recombinant interleukin-2 ( aldesleukin; IL-2 ) at the same time; 3) To radiolabel (mark) the CD8(+) lymphocytes with Indium 111, and then scan the patients to determine the distribution of the CD8(+) lymphocytes in those who are and are not given IL-2 infusions; 4) To determine the toxicity of IL-2 given at the same time with autologous CD8(+) lymphocytes; 5) To measure changes in the immunology of the subjects following these treatments. CD8(+) cells are suppressor/killer lymphocyte cells that act to limit replication of viruses. It is hoped that the reinfusion of activated autologous CD8(+) cells into patients with AIDS will help to control opportunistic infections such as cytomegalovirus and toxoplasmosis (two of the leading causes of sickness and death in AIDS patients). This treatment may also stop the HIV virus from replicating (reproducing itself) in the AIDS patient. Further activation of these cells, once infused, may be necessary. It is hoped that IL-2 will stimulate the patient's immune system against the AIDS virus along with the activated CD8(+) cells. Thus, IL-2 will be given, and its effects studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1993
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 2, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Required:
- Zidovudine (AZT) during treatment and for 20 weeks after the last infusion unless medically contraindicated.
- Allowed:
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Oral antibiotics for PCP prophylaxis if hematologically stable on that regimen for at least 30 days prior to study entry.
- Patients must have the following:
- Positive HIV antibody test by federally licensed ELISA.
- Positive HIV culture or plasma p24 antigen.
- CDC Group IV severe AIDS-related complex (ARC) or AIDS.
- Must have been on zidovudine (AZT) at least 6 weeks prior to infusion and agree to continue this medication during the study and for 20 weeks after the last infusion unless medically contraindicated.
- Allowed:
- Kaposi's sarcoma.
You may not qualify if:
- Co-existing Condition:
- AMENDED:
- Pulmonary diseases that require treatment.
- AMENDED:
- Significant central nervous system disease including AIDS dementia, psychiatric disabilities, or seizure disorders.
- AMENDED:
- Symptomatic HIV CNS infections or symptoms compatible with HIV encephalopathy.
- Original design:
- Patients with the following conditions or symptoms are excluded:
- Active bacterial or opportunistic infection that requires treatment.
- Neoplasms not specifically allowed, basal cell carcinoma of the skin, or in-situ carcinoma of the cervix.
- Clinically significant cardiac (= or \> class II, New York Heart Association) or peripheral vascular disease that requires treatment.
- Hemorrhagic diathesis including hemophilia or active bleeding disorder.
- Concurrent Medication:
- Excluded:
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Related Publications (4)
Torpey D 3rd, Huang XL, Armstrong J, Ho M, Whiteside T, McMahon D, Pazin G, Heberman R, Gupta P, Tripoli C, et al. Effects of adoptive immunotherapy with autologous CD8+ T lymphocytes on immunologic parameters: lymphocyte subsets and cytotoxic activity. Clin Immunol Immunopathol. 1993 Sep;68(3):263-72. doi: 10.1006/clin.1993.1127.
PMID: 8370181BACKGROUNDHo M, Armstrong J, McMahon D, Pazin G, Huang XL, Rinaldo C, Whiteside T, Tripoli C, Levine G, Moody D, et al. A phase 1 study of adoptive transfer of autologous CD8+ T lymphocytes in patients with acquired immunodeficiency syndrome (AIDS)-related complex or AIDS. Blood. 1993 Apr 15;81(8):2093-101.
PMID: 8471768BACKGROUNDHo M, et al. Phase I study of in vitro purified and expanded autologous CD8(+) lymphocytes infused into patients with advanced ARC or AIDS (ACTG 080). Int Conf AIDS. 1991 Jun 16-21;7(2):77 (abstract no THB83)
BACKGROUNDArmstrong JA, Ho M, Herberman R, Elder E, Ferbas J, McMahon D, Gupta P, Rinaldo C, Whiteside T. A phase I study of autologous, activated CD8(+) lymphocytes expanded in vitro infused into patients with advanced ARC or AIDS (ACTG 080). Int Conf AIDS. 1990 Jun 20-23;6(3):208 (abstract no SB491)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
M Ho
- STUDY CHAIR
R Herberman
- STUDY CHAIR
J Armstrong
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
April 1, 1993
Last Updated
November 2, 2021
Record last verified: 2021-10