Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
NCT ID: NCT00001997
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Interleukin-2, Polyethylene Glycolated
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
* HIV seropositivity by commercially available ELISA.
* Meet Disease Status criteria.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Chiron Corporation
INDUSTRY
Locations
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Dr David R Senechek
San Francisco, California, United States
Countries
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Other Identifiers
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CS-PG91-07
Identifier Type: -
Identifier Source: secondary_id
072B
Identifier Type: -
Identifier Source: org_study_id