NCT00002017

Brief Summary

To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Polyethylene GlycolsInterleukin-2

Interventions

Interleukin-2, Polyethylene GlycolatedDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT).
  • Necessary topical agents such as nystatin, clotrimazole, and acyclovir.
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Oral antibiotics for PCP prophylaxis if hematologically stable for = or \> 30 days prior to study entry.
  • Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma.
  • Patients must have:
  • HIV-1 seropositivity.
  • Asymptomatic.
  • No opportunistic infection for 8 weeks prior to study entry.
  • Been on azidothymidine (AZT) (= or \> 500 mg/day) for at least 8 weeks prior to beginning interleukin-2 (IL-2), with stable CD4 cell counts.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT).

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens.
  • Fever = or \> 101 F. within 10 days prior to study entry.
  • Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder.
  • Significant cardiac disease (New York Heart Association Stage III or IV).
  • Significant pulmonary disease (Forced Expiratory Volume \< 75 percent.
  • Weight loss = or \> 10 percent within last 3 months.
  • Concurrent Medication:
  • Excluded:
  • Systemic therapy for opportunistic infection (OI).
  • Patients with the following are excluded:
  • Presence of antibody to interleukin-2 (IL-2).
  • Prior Medication:
  • Excluded within 12 weeks prior to study entry:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller Univ

New York, New York, 10021, United States

Location

Related Publications (4)

  • Teppler H, Montana A, Meyn P, Kaplan G, Cohn ZA. Prolonged immunostimulatory effect of low dose PEG interleukin-2 in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(2):B162 (abstract no PoB 3453)

    BACKGROUND

  • Zhang W, Ruan J, Zhang R, Zhang M, Hu X, Han Z, Ruan Q. Association between age-related hearing loss with tinnitus and cognitive performance in older community-dwelling Chinese adults. Psychogeriatrics. 2022 Nov;22(6):822-832. doi: 10.1111/psyg.12889. Epub 2022 Sep 8.

    PMID: 36075585DERIVED

  • Zhang W, Ruan J, Zhang R, Zhang M, Hu X, Yu Z, Han Z, Ruan Q. Age-Related Hearing Loss With Tinnitus and Physical Frailty Influence the Overall and Domain-Specific Quality of Life of Chinese Community-Dwelling Older Adults. Front Med (Lausanne). 2021 Oct 21;8:762556. doi: 10.3389/fmed.2021.762556. eCollection 2021.

    PMID: 34746196DERIVED

  • Ruan Q, Chen J, Zhang R, Zhang W, Ruan J, Zhang M, Han C, Yu Z. Heterogeneous Influence of Frailty Phenotypes in Age-Related Hearing Loss and Tinnitus in Chinese Older Adults: An Explorative Study. Front Psychol. 2021 Feb 16;11:617610. doi: 10.3389/fpsyg.2020.617610. eCollection 2020.

    PMID: 33664689DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-08

Locations

US(1)