NCT00002254已完成不适用
A Multi-Center, Open-Label, Ascending, Multiple Oral Dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 3
研究概览
简要总结
To assess the tolerance and toxicity profile of deoxy-3'-fluorothymidine (FLT) after multiple oral dosing for 16 weeks. To characterize the steady-state pharmacokinetics of FLT after multiple oral doses. To assess the effect of FLT on immunologic and virologic markers of HIV infection (CD4+ lymphocyte count, p24 antigen, viremia) in patients with AIDS or AIDS related complex (ARC) after multiple oral dosing for 16 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:
- •Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- •Up to 14 days of systemic therapy for minor opportunistic infections such as candidiasis, mucocutaneous Herpes simplex or cutaneous Herpes zoster infections.
- •Patients must have the following:
- •AIDS or AIDS related complex (ARC) as defined by the CDC.
- •Positive antibody to HIV as determined by a commercially licensed ELISA test kit, confirmed by Western blot analysis.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry (progression is defined as more than a 25 percent increase in the product of bidirectional measurement of indicator lesions and/or more than a 25 percent increase in the number of new lesions).
- •Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin. Patients who have had a malignancy in the past that has been in complete remission for 1 year without therapy may be enrolled.
- •Signs or symptoms of neuropathy and a Vibratron 2 score = or > 4 for either great toe.
- •Concurrent Medication:
- •Acute therapy for AIDS-related infection.
- •Systemic maintenance therapy for AIDS-defining opportunistic infection.
- •Recombinant erythropoietin.
- •Long term therapy with either aspirin or probenecid.
- •Concurrent Treatment:
- •Blood transfusion more than once per month.
- •Patients with the following are excluded:
- •Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry.
- •Unwilling to sign an informed consent or patients unwilling to be followed at the medical center where they were enrolled for the duration of the study and follow-up as required.
- •History of intolerance to zidovudine (AZT) at any dose as demonstrated by an AZT related decrease in hemoglobin levels of at least 2 g/dl or AZT related depression of neutrophils of at least 200 cells/mm3 to < 750 cells/mm3 which required discontinuation of AZT therapy.
- •Diseases or conditions listed in Exclusion Co-Existing Conditions.
- •Prior Medication:
- •Antiretroviral agents within 14 days of study entry.
- •Immunomodulating agents or corticosteroids within 30 days prior to study entry.
- •Treatment for acute Pneumocystis carinii pneumonia within 2 weeks prior to study entry.
- •Prior Treatment:
- •Blood transfusions within 7 days prior to study entry.
- •Radiation therapy for Kaposi's sarcoma within 30 days prior to study entry.
- •Active substance abuse.
研究者
研究点 (3)
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