Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
Patients are stabilized on oral AZT daily for 8 weeks and then begin receiving bolus infusions of PEG IL-2 every other week for at least four doses. Thymosin alpha 1 (given SC) is then added to this regimen twice weekly for 4 weeks. If no significant toxicity occurs, thymosin alpha 1 is increased to and administered along with scheduled doses of PEG IL-2 for an additional 8 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Prophylactic pentamidine for Pneumocystis carinii.
- •Patients must have:
- •HIV seropositivity.
- •CD4 count > 50 and < 200 cells/mm
- •No active opportunistic infections.
排除标准
- •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.