ACTRN12605000662662招募中4 期
Analysis of Lipodystrophy in HIV-Infected individualsA prospective, non-randomised, 48 week study of the effect of PI containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Be able to provide written consent to perform in the trial.- HIV antibody positive at time of entry to the study.Specific to HAMA part A only:- Be naive to antiretroviral medication.Specific to HAMA part B only:- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.- Have had a minimum of 48 weeks interval since completion of HAMA part A.
排除标准
- •General:- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.- Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.- Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.- Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.- Prior use of any retinoid-containing compound within the previous six months.- Abnormal coagulation.- Previous allergic reaction or known allergy to local anaesthetic.- Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial.- Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements.- Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.- PregnancySpecific to HAMA part A only:- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). Entry of individuals who have had previous antiretroviral therapy as part of Post Exposure Prophylaxis will be at the discretion of the study investigators.
研究者
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