A Phase I Pilot Study of the Safety and Efficacy of Interferon Alfa-2b (IFN Alfa-2b) in Combination With Nucleoside Analog Therapy in Patients With Combined Hepatitis C (HCV) and Advanced Human Immunodeficiency Virus (HIV) Infections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
研究概览
简要总结
To investigate the toxicity of interferon alfa-2b ( IFN alfa-2b ) in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C. To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy.
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
详细描述
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C. Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C, but the drug's benefit against hepatitis C in patients with advanced HIV infection has not been determined.
Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months. If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy, dose is increased. Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months. All patients will also receive available nucleoside analog therapy ( zidovudine, didanosine, zalcitabine ) at currently accepted doses as clinically appropriate.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Treatment or suppression of opportunistic infections with standard drugs.
- •Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.
- •Clinically indicated antibiotics.
- •Short courses of steroids (< 21 days) for acute problems not related to hepatitis C.
- •Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.
- •Patients must have:
- •HIV positivity.
- •Documented hepatitis C virus.
- •CD4 count <= 200 cells/mm
- •No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.
- •Willingness to be followed for the duration of treatment and follow-up period.
- •Prior Medication:
- •Prior AZT, ddI, and ddC.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Hepatitis B (HBsAg positive).
- •Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160).
- •Wilson's disease.
- •alpha-1 antitrypsin deficiency.
- •Hemochromatosis.
- •Malignancy requiring systemic chemotherapy.
- •Concurrent Medication:
- •Nonnucleoside analog therapy for HIV.
- •Biologic response modifiers.
- •Systemic cytotoxic chemotherapy.
- •Chronic systemic steroid use.
- •Concurrent Treatment:
- •Radiation therapy other than local irradiation to the skin.
- •Prior Medication:
- •Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).
- •Acute therapy for an infection within 2 weeks prior to study entry.