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Sponsored by: |
Chiron Corporation |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00001997 |
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 |
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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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
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.
Study ID Numbers: | 072B, CS-PG91-07 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001997 |
Health Authority: | United States: Food and Drug Administration |
Recombinant Proteins Polyethylene Glycols Interleukin-2 Didanosine Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral Didanosine HIV Seropositivity Interleukin-2 HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Lentivirus Infections Peripheral Nervous System Agents Analgesics Central Nervous System Agents Nucleic Acid Synthesis Inhibitors |