NCT00751153Unknown4 期
Open Label Phase 4, 48 Week Pilot Study of the Antiviral Efficacy and Tolerability of the Combination of Isentress™ and ReyatazTM When Substituted for Current Antiviral Regimen in Patients With Viral Suppression But Who Are Experiencing Adverse Events Related to Their Current Antiviral Regimen.
Peter J. Ruane, M.D., Inc.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluation of the proportion of patients who maintain plasma HIV viral load measurements < 400 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir
研究概览
简要总结
Subjects with HIV who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of Raltegravir and Atazanavir and be monitored for viral and immunological response and quality of life.
详细描述
Subjects with intolerance to current regimen will receive Raltegravir 400 mg twice daily and Atazanavir 400 mg daily will be monitored for viralogical and immunological outcomes, changes in lipids, renal and hepatic safety and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •History of no PI resistance or antiretroviral failure while receiving a PI.
- •On a current antiviral regimen with plasma HIV viral load (VL) < 400 copies/ml for 4 months or longer.
- •Intolerance to or toxicity with current or alternative regimen(s) with side effects including but not limited to gastrointestinal, neurological, metabolic, or dysmorphic symptoms and/or dyslipidemia.
- •Continuously using the same regimen for 3 months prior to Screening.
- •Women of childbearing potential must be willing to use effective method(s) of contraception throughout their study participation and for 30 days following the end of the study (see Section 1.10). -Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.
- •Willing to adhere to the prohibitions and restrictions specified in this protocol.
排除标准
- •Use of any drug contraindicated in the current US package insert for Atazanavir or in the investigators brochure for Raltegravir, including PPI inhibitors.
- •Use of any investigational drug up to 4 weeks prior to screening.
- •Prior or current therapy with Raltegravir.
- •Allergy to Raltegravir or Atazanavir
- •History of medication non-compliance significant to the study regimen as deemed significant by the investigator.
- •Known achlorhydria that would inhibit the absorption of Atazanavir
- •Concurrent active chronic Hepatitis B requiring therapy with 3TC, FTC or Tenofovir (entecavir permitted).
- •AST or ALT >5 times ULN
- •Calculated CrCl < 30 ml/min.
- •Female subject who is pregnant or breastfeeding.
- •General medical condition that may interfere with the assessments and completion of the trial.
结局指标
主要结局
Evaluation of the proportion of patients who maintain plasma HIV viral load measurements < 400 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir
时间窗: 48 weeks
次要结局
- Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir(48 weeks)
- Evaluation of the proportion of patients who have plasma HIV viral load measurements <50 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir(48 weeks)
- Time to virologic failure (defined as 2 consecutive VL measurements > 400 copies/ml on 2 separate clinic visits within 4 weeks)(48 weeks)
- Patient adherence to a regimen of Raltegravir and Atazanavir(48 weeks)
- Assessment of lipid changes after change in regimen(48 weeks)
- Determination of incidence, genotypic and phenotypic resistance patterns, in particular to Raltegravir and Atazanavir, in patients in the event of rebound viremia(48 weeks)
研究者
研究点 (2)
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