Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylactic pentamidine for Pneumocystis carinii.

Patients must have:

• HIV seropositivity.
• CD4 count > 50 and < 200 cells/mm3.
• No active opportunistic infections.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or Kaposi's sarcoma.
• Significant cardiac disease or CNS lesions or other neurologic abnormalities.
• Score of > 0.5 on ACTG AIDS Dementia Complex staging.
• Major organ allograft.
• Intolerance to AZT at 500 mg/day.

Concurrent Medication:

Excluded:

• Antihypertensive medication other than diuretics.
• Chemotherapy, hormonal therapy, or other immunotherapy.
• Other investigational drugs, agents, or devices.
• Beta-blockers.
• Non-topical steroids.

Concurrent Treatment:

Excluded:

• Radiation therapy.

Prior Medication:

Excluded:

• Known anti-HIV medication (other than AZT) or known immunomodulators (e.g., systemic steroids, interferons, interleukins) or other chemotherapy within 30 days prior to study entry.

Prior Treatment:

Excluded:

• Transfusion within 4 weeks prior to study entry.
• Radiation within 30 days prior to study entry.

Active substance abuse.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety