Overview

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.