ACTRN12605000132640终止4 期
A multi-centre, open-label, randomised study to assess the efficacy, durability and safety of immediate versus deferred injections of poly-L-lactic acid for HIV facial lipoatrophy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
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
- Randomised controlled trial
- 主要目的
- Treatment
- 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
- •Laboratory evidence of HIV-1 infection- received combination antiretroviral therapy (min 2 agents) - antiretroviral regimen should be stable for at least 12 weeks prior to entry with no changes planned during the first 48 weeks. For subjects not on antiretroviral therapy at entry there should be no intent to commence therapy in first 24 weeks - moderate or severe facial lipoatrophy and lipodystrophy at one or more other sites- provide written, informed consent.
排除标准
- •Active AIDS-defining illness including active HIV wasting- active herpes labialis or any acute or currently present chronic skin disease (infection/inflammation) on/near area to be treated- currently on anticoagulants or any coagulopathy that would preclude safe deep subcutaneous injections - women: pregnant, breastfeeding or have positive pregnancy test or not willing to use adequate contraception if of child-bearing potential- concomitant therapy with anabolic steroids (except testosterone replacement), corticosteroids at greater than replacement doses, growth hormone or any currently available or experimental agent to improve appetite or weight - testosterone replacement for less than 6 months or at greater than replacement doses - subjects who have discontinued any prohibited concomitant agent/s must cease this therapy at least 30 days prior to screening - prior use of any facial dermal filling/tissue expansion agent/s - any condition which may interfere with ability to comply with study requirements.
研究者
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