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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interleukin-2, Polyethylene Glycolated
Zidovudine
Didanosine
Sponsored by
Chiron Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Polyethylene Glycols, Interleukin-2, Didanosine, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr David R Senechek

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Chiron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00001997
Brief Title
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
Official Title
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
July 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chiron Corporation

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Recombinant Proteins, Polyethylene Glycols, Interleukin-2, Didanosine, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interleukin-2, Polyethylene Glycolated
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Dr David R Senechek
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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