We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00001997
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
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.
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.
Interventional
Not Provided
Primary Purpose: Treatment
HIV Infections
  • Drug: Interleukin-2, Polyethylene Glycolated
  • Drug: Zidovudine
  • Drug: Didanosine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001997
072B
CS-PG91-07
Not Provided
Not Provided
Not Provided
Not Provided
Chiron Corporation
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
July 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP