An Open-Label Safety Trial of Enfuvirtide (T-20/RO 29-9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiviral Regimen in Thai Patients With Advanced HIV Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Number of Participants With Premature Withdrawal Due to Adverse Events
研究概览
简要总结
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals at least 16 years of age infected with HIV-1
- •CD4 lymphocyte count less than equal to (<=) 100 cells per cubic millimeter (cells/mm^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
- •Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens
排除标准
- •Evidence of ongoing alcohol and/or drug or substance abuse
- •Prior non-adherence to antiretroviral treatment regimens
- •Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.
研究组 & 干预措施
Enfuvirtide
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).
干预措施: Enfuvirtide (Drug)
结局指标
主要结局
Number of Participants With Premature Withdrawal Due to Adverse Events
时间窗: Up to 96 weeks
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.
次要结局
未报告次要终点