NCT00000986

Brief Summary

To test the safety and tolerance of three different doses of recombinant human interleukin 2 (aldesleukin; IL-2), when it is given for five consecutive days to patients with AIDS or AIDS related complex (ARC), who have also received zidovudine (AZT) for at least 6 weeks just before beginning the IL-2 treatment. AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS. IL-2 is a substance found naturally in the body that boosts the body's immune response to invading organisms and tumor cells. These two drugs, when administered together, may have a mutually helpful effect in treating AIDS patients, but before this effect can be studied, it is important to understand the proper dose and any side effects that may occur when these drugs are used together. The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will interact with each other.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 hiv-infections

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

Study Completion

Last participant's last visit for all outcomes

January 1, 1994

Completed
5.8 years until next milestone

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

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Recombinant ProteinsInterleukin-2Drug InteractionsDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudine

Interventions

ZidovudineDRUG
AldesleukinDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Acetaminophen under the supervision of a study physician.
  • Prior Medication:
  • Required for at least 6 weeks prior to study entry:
  • Zidovudine at a dose of at least 300 mg/day.
  • Allowed:
  • Aerosolized pentamidine prior to combination therapy.
  • Patients must demonstrate the following clinical and laboratory findings:
  • Currently receiving zidovudine (AZT) at a dose of at least 300 mg/day and have received the drug for at least 6 weeks.
  • Have a life expectancy of = or \> 4 months.
  • Available for the duration of the study and for follow-up visits.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions will be excluded:
  • Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy.
  • A fever \> 101 degrees F within the past 10 days.
  • Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders.
  • Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume \< 75 percent).
  • Kaposi's sarcoma or other AIDS related malignancy.
  • Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months.
  • Concurrent Medication:
  • Excluded:
  • Cardiac medications.
  • Glucocorticosteroids.
  • Probenecid.
  • Acetylsalicylic acid.
  • Trimethoprim / sulfamethoxazole.
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

  • McMahon DK, Armstrong JA, Huang XL, Rinaldo CR Jr, Gupta P, Whiteside TL, Pazin GJ, Tripoli C, Ho M. A phase I study of subcutaneous recombinant interleukin-2 in patients with advanced HIV disease while on zidovudine. AIDS. 1994 Jan;8(1):59-66. doi: 10.1097/00002030-199401000-00009.

    PMID: 8011237BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudinealdesleukin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • M Ho

    STUDY CHAIR

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

January 1, 1994

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(1)