Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
研究概览
简要总结
This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.
详细描述
EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients previously enrolled in the MK 0518 EAP are eligible
- •Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:
- •Age >= 16 years
- •Limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, documented resistance to at least one drug in each of the 3 classes of oral ARTs (NRTI, NNRTI, PI) by genotype or phenotype testing, intolerance defined as having had a clinically significant adverse event which in the opinion of the clinician provides a contraindication to the use of any drug in that class iii. Patient did not achieve virologic suppression on ART regimen prior to receipt of raltegravir iv. Patient was clinically stable at time of initiation of raltegravir, eg. clinical status and all chronic medications (except ARTs) unchanged for >= 2 weeks prior to raltegravir receipt.
- •Patient received raltegravir for at least 8 weeks
- •Baseline and week 8 or later HIV viral load done and available for review
- •Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir
排除标准
- •Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
- •Patient chart not available for review.
研究组 & 干预措施
Protease Inhibitor Group
Subjects who required a protease inhibitor in their new ART regimen
干预措施: raltegravir (Drug)
Non-protease Inhibitor
Subjects who did not take a protease inhibitor in their regimen
干预措施: raltegravir (Drug)
结局指标
主要结局
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
时间窗: 12 Weeks
The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
次要结局
- Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12(12 weeks)
- CD4 Cell Changes Among Participants in PI vs Non-PI Group(baseline to 24 Weeks)
- Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)(Baseline)
- Percentage of Participants Using Etravirine in Background Regimen(Background regimen (no specific time frame))