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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockefeller University
• Treatments: Interleukin-2

Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.