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

Not Recruiting

Trial ID: NCT00001036


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.

Official Title

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

Stanford Investigator(s)


Inclusion Criteria

Concurrent Medication:


   - 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:


   - Antihypertensive medication other than diuretics.

   - Chemotherapy, hormonal therapy, or other immunotherapy.

   - Other investigational drugs, agents, or devices.

   - Beta-blockers.

   - Non-topical steroids.

Concurrent Treatment:


   - Radiation therapy.

Prior Medication:


   - 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:


   - Transfusion within 4 weeks prior to study entry.

   - Radiation within 30 days prior to study entry.

Active substance abuse.


drug: Thymalfasin

drug: Interleukin-2, Polyethylene Glycolated

drug: Zidovudine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305