AzTrials
AzTrials

HIV InfectionsPhase 1NCT00000680

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

A Phase 1 study testing Zidovudine and Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Aldesleukin
How many people
6 participants
Where
1 siteUnited States
Study dates
Start not givento Apr 1993
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Co-existing Condition:
  • AMENDED:
  • Pulmonary diseases that require treatment.
  • AMENDED:
  • Significant central nervous system disease including AIDS dementia, psychiatric disabilities, or seizure disorders.
  • AMENDED:
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Univ of Pittsburgh Med School

    Pittsburgh, Pennsylvania

Other trials in United States

About this study

  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.

Read the detailed 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 virus along with the activated CD8(+) cells. Thus, IL-2 will be given, and its effects studied.

AMENDED: 09/28/90 The CD8 lymphocytes are grown in vitro for 21 days before infusion. Leukapheresis and infusion continue every 21 days for 3 infusions with the last infusion during week 16. During weeks 13 and 16, indium 111 radio labelled cells are injected to permit determination of the distribution and pharmacokinetics of the infused cells. At week 16, IL-2 is administered concurrently with Indium 111 labelled cells and the CD8+ lymphocytes - delivered by continuous infusion over 5 days following cell infusion. Patients are followed at the clinic 1 week prior to scheduled infusions, during infusion weeks and then every 2 weeks to week 21 and at week 27. Original design: Patients undergo leukapheresis every 2 weeks for a total of 6 times during the initial phase of the study. During this procedure, a catheter is placed in an arm vein, and the blood flows through a machine which separates the lymphocytes from the other blood components. The blood is then returned to the patient's body through the catheter. Less than 10 percent of the lymphocytes in the blood are removed during the process. The CD8(+) cells taken from the patient are cultured in the laboratory until they increase 10- to 1000-fold. These cells are then infused back into the patient from whom they were taken. The first two patients are admitted for 24 hours at the time of each infusion. In the absence of severe side effects, the subsequent four patients are infused at the clinic. Patients are admitted for 5 days for continuous infusion of IL-2 in week 13.

Conditions
HIV Infections
Being tested
Zidovudine, Aldesleukin
Keywords
T-Lymphocytes, Suppressor-Effector, Indium Radioisotopes, Leukapheresis, Interleukin-2, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Immunization, Passive
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionApr 1993

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
6 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000680
Sponsor's protocol ID
ACTG 080
Other IDs
11055
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
2 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 8370181

  • Ho 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.

    PubMed 8471768

  • Ho 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)

  • Armstrong 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)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zidovudine and Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000680, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.

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