Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine or Dideoxyinosine in HIV Positive, Asymptomatic and Symptomatic Individuals
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1991
History of Changes
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.
Drug : Interleukin-2, Polyethylene Glycolated
Drug : Zidovudine
Drug : Didanosine
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:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- HIV seropositivity by commercially available ELISA.
- Meet Disease Status criteria.
- 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.
- Drug therapy anticipated to lead to renal compromise.
- 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.
- Any prior therapy with interleukin-2 (IL-2) or PEG IL-2.
- Treatment with other anti-HIV medication or known immunomodulators or other chemotherapy
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Excluded 30 days prior to study entry:
Active substance abuse so patients would be anticipated to be poorly compliant with protocol requirements.
Contacts and LocationsChoosing 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 Show More
|United States, California|
|Dr David R Senechek|
|San Francisco, California, United States, 94108|
Sponsors and CollaboratorsChiron Corporation
|Responsible Party:||Chiron Corporation|
|ClinicalTrials.gov Identifier:||NCT00001997 History of Changes|
|Other Study ID Numbers:||072B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Recombinant Proteins
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 28, 2020
This information is provided by ClinicalTrials.gov.