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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Chiron Corporation
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00001997
  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: Treatment, Dose Comparison, Safety Study
Official Title: Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

Study ID Numbers: 072B, CS-PG91-07
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00001997     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Recombinant Proteins
Polyethylene Glycols
Interleukin-2
Didanosine
Zidovudine

Study placed in the following topic categories:
Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Didanosine
Anti-Retroviral Agents
HIV Seropositivity
Analgesics, Non-Narcotic
HIV Infections
Interleukin-2
Sexually Transmitted Diseases
Peripheral Nervous System Agents
Analgesics
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Didanosine
Analgesics, Non-Narcotic
HIV Infections
Interleukin-2
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on July 02, 2009