NCT00005120Unknown1 期
A Phase IB Study to Evaluate the Safety, Pharmacokinetics, and Effects of (+)-Calanolide A on Surrogate Markers in HIV-Positive Patients With No Previous Antiretroviral Therapy
Sarawak MediChem Pharmaceuticals13 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2000年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 13
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
详细描述
Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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
- •Patients may be eligible for this study if they:
- •Are at least 18 years old.
- •Agree to use effective methods of birth control during the study.
- •Have a CD4 cell count of 200 cells/mm3 or more.
- •Have HIV levels of 5000 copies/ml or more.
排除标准
- •Patients will not be eligible for this study if they:
- •Have abnormal blood tests.
- •Have had a reaction to study medication.
- •Have a history of opportunistic (AIDS-related) infection or cancer.
- •Are being treated for active pulmonary tuberculosis.
- •Have a fever of 39 degrees C or more within 14 days of beginning study treatment.
- •Are unable to take medications by mouth.
- •Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment.
- •Have hepatitis, hemophilia, or other blood disorder.
- •Have significant heart, stomach, intestinal, liver, nerve, or kidney problems.
- •Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder.
- •Have taken anti-HIV drugs in the past.
- •Are taking certain medications.
- •Have had a blood transfusion within the 3 months prior to entering the study.
- •Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study.
- •Are pregnant or breast-feeding.
研究者
研究点 (13)
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