A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
研究概览
简要总结
To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with HIV infection and CD4 count < 400 cells/mm3.
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.
详细描述
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.
Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. Mean duration of follow-up is expected to be 13 months.
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:
- •Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine).
- •Phenytoin for < grade 2 peripheral neuropathy.
- •A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP).
- •Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis.
- •Patients must have:
- •HIV infection.
- •CD4 count < 400 cells/mm3 within 30 days prior to study entry.
- •Minimal Kaposi's sarcoma is allowed.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Active opportunistic infection requiring acute therapy.
- •Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection.
- •Malignancy (other than minimal Kaposi's sarcoma) requiring therapy.
- •Grade 2 or worse peripheral neuropathy.
- •Concurrent Medication:
- •Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs).
- •Recombinant erythropoietin, G-CSF, or GM-CSF.
- •Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs).
- •Concurrent Treatment:
- •Radiation therapy (unless approved by the protocol chairs).
- •Patients with the following prior conditions are excluded:
- •History of intolerance to AZT at 600 mg/day or less.
- •Unexplained temperature of 38.5 degrees C persisting for 14 days or longer.
- •Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14 days or longer.
- •Prior Medication:
- •Acute therapy for opportunistic infection within 14 days prior to study entry.
- •Prior ddC, ddI, or IFN alfa-2a.
- •Active substance abuse.