Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.

Key facts

Study ID

NCT00002017

Run by

Rockefeller University

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Zidovudine (AZT).
• Necessary topical agents such as nystatin, clotrimazole, and acyclovir.
• Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
• Oral antibiotics for PCP prophylaxis if hematologically stable for = or > 30 days prior to study entry.
• Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma.
• Patients must have:
• HIV-1 seropositivity.
• Asymptomatic.
• No opportunistic infection for 8 weeks prior to study entry.
• Been on azidothymidine (AZT) (= or > 500 mg/day) for at least 8 weeks prior to beginning interleukin-2 (IL-2), with stable CD4 cell counts.
• Prior Medication:
• Allowed:
• Zidovudine (AZT).

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens.
• Fever = or > 101 F. within 10 days prior to study entry.
• Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder.
• Significant cardiac disease (New York Heart Association Stage III or IV).
• Significant pulmonary disease (Forced Expiratory Volume < 75 percent.
• Weight loss = or > 10 percent within last 3 months.
• Concurrent Medication:
• Excluded:
• Systemic therapy for opportunistic infection (OI).
• Patients with the following are excluded:
• Presence of antibody to interleukin-2 (IL-2).
• Diseases or symptoms listed in Exclusion Co-Existing Conditions.
• Prior Medication:
• Excluded within 12 weeks prior to study entry:
• Other immunomodulators.
• Corticosteroids.
• Other experimental therapy.
• Anti-neoplastic chemotherapy.
• Active drug or alcohol abuse.

Where it is running

• Rockefeller Univ — New York, New York, United States

Full record on ClinicalTrials.gov

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