Portilla Joaquín, Boix Vicente, Garcia-Henarejos José Antonio, Llopis Coral, Martínez-Madrid Onofre, Gimeno Adelina, Sánchez-Paya José, Merino Esperanza
Unit of Infectious Diseases, Hospital General Universitario de Alicante, Spain.
Int J STD AIDS. 2005 Dec;16(12):807-10. doi: 10.1258/095646205774988082.
To analyse if a four-drug combination including two protease inhibitors (PIs) accelerates viral decay and suppression as compared with standard triple therapy in heavily immunosuppressed HIV-1 infected patients, an open label clinical trial was designed. PIs naive patients receiving their first highly active antiretroviral therapy were included if their CD4 cell count was lower than 200/mm3 and their HIV viral load (VL) >100,000 RNA copies/mL. Every patient received two analogues and was randomized in two groups receiving either one PI (saquinavir soft gel capsule) or two PIs (saquinavir + nelfinavir). Viral efficacy (VL <50), time to reach VL <50, viral clearance rate constant and plasmatic elimination half-life were determined. In all, 30 patients were enrolled. No viral variable was significatively improved by the four-drug combination in the short term. No clinical benefit should be expected with a four-drug (two PIs) regimen in patients with low CD4+ cell count and high VL.
为分析在免疫严重抑制的HIV-1感染患者中，与标准三联疗法相比，包含两种蛋白酶抑制剂（PI）的四联药物组合是否能加速病毒衰减和抑制，设计了一项开放标签临床试验。纳入首次接受高效抗逆转录病毒治疗且PI初治的患者，条件为其CD4细胞计数低于200/mm3且HIV病毒载量（VL）>100,000 RNA拷贝/mL。每位患者接受两种类似物，并随机分为两组，一组接受一种PI（沙奎那韦软胶囊），另一组接受两种PI（沙奎那韦+奈非那韦）。测定病毒疗效（VL<50）、达到VL<50的时间、病毒清除率常数和血浆消除半衰期。总共招募了30名患者。短期内，四联药物组合并未显著改善任何病毒变量。对于CD4+细胞计数低且VL高的患者，四联（两种PI）方案不应期望有临床益处。
