A Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of Lessertia Frutescens (L.)Goldblatt and J.C. Manning (Syn. Sutherlandia Frutescens (L.)R. Br.)in HIV-infected South African Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression.
研究概览
简要总结
The study is a 2-stage, double-blind, randomized, placebo-controlled study in which fifty-six HIV-positive subjects will be randomized into the first stage. Interim analysis to determine continuation to stage 2 will be performed to determine continuation after 8 subjects per arm have completed a 24-week dosing regimen.
Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1 infected adults with early disease, and to document the impact of Lessertia frutescens on markers of HIV disease progression. Secondary objective is to determine the effect of Lessertia frutescens on quality of life in HIV-infected adults and length of infection.
详细描述
The study is a 2-stage, double-blind, randomized, placebo-controlled study following a two-stage, statistical selection theory design. Fifty-six HIV positive subjects will be randomized onto Stage 1 that will comprise a 4-arm parallel group (one placebo and 3 treatment groups) trial. One or possibly two interim analyses will be performed to determine continuation to Stage 2. A blinded interim analysis to determine the superior active treatment arm of Stage 1 will be continued to Stage 2 after 8 subjects per arm have completed the 24-week dosing regimen and the interim analysis. The study will be terminated if the interim analysis identifies either significant safety issues, or demonstrable non-significance. Following a significant outcome in the blinded interim analysis, the selected active and placebo control arms will continue blinded until total n=48 participants per arm for the placebo and selected treatment group have completed 24 weeks per arm. Respective groups will receive capsules containing L. frutescens in dosages of 0 (placebo material), 400mg bid, 800 mg bid or 1200 mg bid in the first stage. Progression to stage 2 will utilize a two arm design in which 34 subjects will receive either 0 mg L. frutescens (placebo) or the active dosage of L. frutescens bid for 24 weeks.
Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1 infected adults with early disease, and to document the impact of Lessertia frutescens on markers of HIV disease progression. Secondary objective is to determine the effect of Lessertia frutescens on quality of life in HIV-infected adults and length of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 - 65 years
- •HIV-1 infection documented by two different rapid tests for HIV-1 antibodies
- •CD4 count >350 cells/ul
- •Viral load< 20,000 copies/mL
- •Normal hematological function
- •Absence of clinically significant renal disease
- •Normal liver function
- •Random glucose < 11.1 mmol/L
- •Normal electrocardiogram
- •Regular attendance at the Wellness Clinic for at least 4 visits
- •Cognitive capacity sufficient to provide informed consent
排除标准
- •Any AIDS-defining diagnosis
- •Weight loss > 5% of body weight within the preceding six months
- •Other features of undiagnosed tuberculosis (including cough, fatigue, drenching night sweats and abnormal chest radiograph)
- •Any other significant disease (active TB, hypertension, diabetes mellitus and other endocrine disorders, peptic ulcer disease, gastrointestinal malabsorption, psychiatric illness) either newly diagnosed or controlled by medication.
- •Use of any allopathic or traditional medicine other than isoniazid for TB prophylaxis.
- •Prior or current use of antiretroviral therapy
- •History of allergic conditions or drug allergy/hypersensitivity
- •Either history or family history of autoimmune disease
- •Alcohol use of >7 units per week or >3 per session, tobacco use of more than 10 cigarettes per day or description of recreational drug use within the past 6 months.
研究组 & 干预措施
Placebo
Placebo (capsule filled with inert materials)
干预措施: Placebo (Drug)
Low Dose
400 mg bid Lessertia Frutescens
干预措施: Low Dose (Drug)
Mid Dose
800 mg bid Lessertia Frutescens
干预措施: Mid Dose (Drug)
High Dose
1200 bid Lessertia Frutescens
干预措施: High Dose (Drug)
结局指标
主要结局
Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression.
时间窗: 24 week treatment period
次要结局
- Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection.(24 week treatment period)