The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection

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

Summary

To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and pharmacokinetic markers.

AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-2; Thymalfasin; Zidovudine

Criteria

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.