Search / Trial NCT00000680

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 23, 2024

Completed

Keywords

T Lymphocytes, Suppressor Effector Indium Radioisotopes Leukapheresis Interleukin 2 Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Immunization, Passive

Description

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 vir...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • 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.
  • Exclusion Criteria
  • 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:
  • Antineoplastic therapy.
  • Medication required for treatment of active cardiac disease.
  • Cardiac glycosides.
  • Antiarrhythmics.
  • Antianginal agents.
  • Anticoagulants.
  • Thrombolytic agents.
  • Vasodilators.
  • Excluded within 30 days of study entry:
  • Antiretroviral agents not specifically allowed.
  • Corticosteroids.
  • Acyclovir.
  • Excluded within 60 days of study entry:
  • Biological response modifiers.
  • Patients with the following are excluded:
  • Unable to give properly informed consent by reason of impaired mentation.
  • Diseases and conditions specified elsewhere in the protocol.
  • Required:
  • Zidovudine (AZT) for at least 6 weeks prior to infusion.
  • Risk Behavior: Excluded:
  • Active substance abuse.

Attachments

readout_NCT00000680_2024-05-23.pdf

4.5 MB

NCT00000680_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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