Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 63
- 主要终点
- Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores
研究概览
简要总结
This is a multi-center, longitudinal observational study of adult human immunodeficiency virus (HIV) participants at academic and community-based practices in the United States who are switching from first-line to second-line therapy. The study's primary hypothesis is that HIV participants switching to raltegravir-based regimens will have better Medical Outcomes Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Clinical diagnosis of HIV
- •Switching antiretroviral regimen(s) for the first time at the start of the study
排除标准
- •Currently pregnant
- •Presence of active tuberculosis, Hepatitis B, and/or Hepatitis C and receiving treatment for the condition(s) during the study period
- •Presence of active pneumonia or other signs of opportunistic infections at the start of the study
- •Currently participating in a clinical trial
结局指标
主要结局
Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores
时间窗: Week 4 Follow-up
The MOS-HIV scale is a 35-item measure of health related quality of life (QOL) questionnaire which assesses 10 dimensions of health (general health perceptions, pain, physical functioning, role functioning, social functioning, mental health, energy/fatifue, cognitive function, health distress and QOL), as well as a single item to assess health transition. In addition to these subscales, a Physical Health Summary score (PHS) and a Mental Health Summary score (MHS) is calculated using a method where the summary scores are transformed to a standardized scale with a norm of 50 and a standard deviation of 10 in the sample in which the summary scores were developed. The subscales of the MOS-HIV are scored as summed rating scales ranging from a minimum of 0, to a maximum of 100, where higher scores indicate better health.
次要结局
- Change From Baseline in HIV Symptom Index (HIV-SI)(Baseline and Week 4 Follow-up)
- Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)(Baseline and Week 4 Follow-up)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline and Week 4 Follow-up)