A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
研究概览
简要总结
PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151.
SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity.
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
详细描述
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Patients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Required for patients with CD4 count <= 200 cells/mm3:
- •PCP prophylaxis using TMP/SMX or aerosolized pentamidine.
- •Topical antifungal agents.
- •Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.
- •Antibiotics for bacterial infections.
- •Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.
- •Patients must have:
- •HIV infection.
- •CD4 count 150 - 500 cells/mm3.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Unable to tolerate the standard diet required for the study.
- •Unable to give informed consent.
- •Concurrent Medication:
- •Antiretrovirals and biologic response modifiers (including HIV vaccines).
- •Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
- •Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
- •Allopurinol.
- •Omeprazole.
- •Astemizole.
- •Terfenadine.
- •Loratadine.
- •Psychotropics.
- •Phenylbutazone.
- •Barbiturates.
- •Benzodiazepines.
- •Monoamine oxidase inhibitors.
- •H-2 blockers.
- •Anticonvulsants.
- •Coumadin anticoagulants.
- •Oral contraceptives.
- •Antiarrhythmics.
- •Diltiazem.
- •Metronidazole.
- •Erythromycin.
- •Chloramphenicol.
- •Fluoroquinolones.
- •Disulfiram.
- •Erythropoietin.
- •G-CSF or GM-CSF.
- •Systemic corticosteroids.
- •Alcohol, including alcohol-containing medications.
- •Patients with the following prior conditions are excluded:
- •Unexplained temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.
- •Chronic diarrhea (>= three stools per day) for any 15 days within the 30 days prior to study entry.
- •Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma.
- •Prior Medication:
- •Excluded at any time:
- •Prior HIV protease inhibitor.
- •Excluded within 30 days prior to study entry:
- •Investigational drugs.
- •Recombinant erythropoietin.
- •G-CSF or GM-CSF.
- •Interferon or interleukin.
- •Any HIV-1 vaccine.
- •Excluded within 14 days prior to study entry:
- •Antiretrovirals.
- •Acute therapy for any opportunistic or other serious infection.
- •Therapy for malignancy.
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