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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
Purpose
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)
Eligibility
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.
Intervention(s):
drug: Thymalfasin
drug: Interleukin-2, Polyethylene Glycolated
drug: Zidovudine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305