Pharmacotherapy for HIV Infected Patients With Alcohol Problems
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Frequency of heavy drinking
研究概览
简要总结
This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks.
The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels.
Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be HIV-positive.
- •Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
- •Not be abstinent from alcohol for greater than 30 days.
- •Be at least 18 years old.
- •Be able to understand English and provide informed consent
排除标准
- •Be psychotic or severely psychiatrically disabled.
- •Have medical conditions that would preclude completing or be of harm during the course of the study.
- •Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
- •Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
- •Be pregnant, nursing or unable to use an effective method of birth control (women).
- •Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.
研究组 & 干预措施
1
Naltrexone
干预措施: Naltrexone (Drug)
2
干预措施: Naltrexone (Drug)
结局指标
主要结局
Frequency of heavy drinking
时间窗: 12 weeks
次要结局
- HIV biological markers(12 weeks)
- Sexual risk behavior(12 weeks)
- Tolerability and retention in alcohol treatment(12 weeks)