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Clinical Trials

MainTitle

Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals

This study has been completed
Sponsor
Chiron Corporation


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00001997

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1991
History of Changes
Purpose

Purpose

To investigate the safety of polyethylene glycolated interleukin-2 (PEG IL-2) given subcutaneously in conjunction with antiviral treatment and to explore the effects of treatment on surrogate markers of efficacy and incidence of opportunistic infection and other clinical markers of HIV disease.

Condition Intervention
HIV Infections

Drug : Interleukin-2, Polyethylene Glycolated
Drug : Zidovudine
Drug : Didanosine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Four escalating doses of PEG IL-2 are studied. Patients are stratified by CD4 level. CD4 levels in Group A are 200 to 500 cells/mm3; in Group B - 1 to less than 200 cells/mm3. Further stratification is by p24 positive or negative, antiviral therapy for more or less than a year, and zidovudine (AZT) versus didanosine (ddI). The duration of PEG IL-2 treatment is a maximum of 28 weeks. This is an outpatient study; patients will be observed for four hours after the first dose of PEG IL-2 and for one hour after subsequent doses.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
Patients must have:

  • HIV seropositivity by commercially available ELISA.
  • Meet Disease Status criteria.

  • Exclusion Criteria
    Co-existing Condition:
    Patients with the following conditions or symptoms are excluded:
  • Concurrent neoplasms other than basal cell carcinoma of the skin, in-situ carcinoma of the cervix or limited cutaneous Kaposi's sarcoma.
  • Recently treated HIV-related lymphoma.
  • Major organ allograft.
  • Presence of space occupying central nervous system (CNS) lesions or other conditions which would be anticipated to cause cerebral edema.
  • Renal compromise or use of drug therapy anticipated to lead to renal compromise.
  • Active opportunistic infection requiring hospitalization or exclude medication.
  • Requiring continual acyclovir for suppression of herpes infection.

  • Concurrent Medication:
    Excluded:
  • Acyclovir.
  • Drug therapy anticipated to lead to renal compromise.

  • Patients with the following are excluded:
  • Intolerance to zidovudine (AZT) at 300 mg/day divided q8h or didanosine (ddI) at 7 mg/kg/day given twice a day.
  • History of HIV-related lymphoma.
  • History of asthma requiring frequent therapy, chronic pulmonary disease, hypertension requiring therapy, or congestive heart failure.
  • Any of the symptoms or conditions listed in Exclusion - Co-Existing Conditions.

  • Prior Medication:
    Excluded:
  • Any prior therapy with interleukin-2 (IL-2) or PEG IL-2.

  • Excluded 30 days prior to study entry:
  • Treatment with other anti-HIV medication or known immunomodulators or other chemotherapy
or radiation therapy.
Active substance abuse so patients would be anticipated to be poorly compliant with protocol requirements.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001997

Locations

United States, California
Dr David R Senechek
San Francisco, California, United States, 94108

Sponsors and Collaborators

Chiron Corporation
More Information

More Information


Responsible Party: Chiron Corporation  
ClinicalTrials.gov Identifier: NCT00001997   History of Changes  
Other Study ID Numbers: 072B  
  CS-PG91-07  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Polyethylene Glycols
Interleukin-2
Didanosine
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Zidovudine
Didanosine
Interleukin-2

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.