Jabs Douglas A, Gilpin Adele M Kaplan, Min Yuan-I, Erice Alejo, Kempen John H, Quinn Thomas C
Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
AIDS. 2002 Apr 12;16(6):877-87. doi: 10.1097/00002030-200204120-00007.
To determine the association of cytomegalovirus (CMV) viremia with mortality and CMV retinitis progression in newly diagnosed and relapsed CMV retinitis.
Ancillary study of a randomized, placebo-controlled, phase III clinical trial.
A total of 83 patients with AIDS and CMV retinitis, enrolled during the first phase of the Monoclonal Antibody Cytomegalovirus Retinitis Trial, were administered MSL-109 or placebo as adjuvant therapy for CMV retinitis.
MAIN OUTCOME MEASURE(S): Mortality and CMV retinitis progression.
Treatment with MSL-109 did not predict either progression of CMV retinitis or mortality. Detection in plasma CMV DNA at baseline predicted mortality, but CMV antigenemia did not. CMV DNA was a better predictor of mortality than a high HIV viral load. Neither CMV DNA nor antigenemia predicted the progression of CMV retinitis. Among newly diagnosed patients, there was a decline in the proportion with detectable CMV viral load and CMV antigenemia in response to anti-CMV therapy. However, there was a rebound in CMV viral load to 25% and CMV antigenemia to 54.6% at 6 months. In relapsed patients, anti-CMV therapy was not associated with a change in the percentage with detectable CMV-DNA or CMV antigenemia over time.
In patients with AIDS and CMV retinitis, the detection of plasma CMV DNA was associated with a higher risk of mortality than was a high HIV viral load. Anti-CMV therapy provided a transient reduction in CMV viremia in newly diagnosed but not relapsed patients with CMV retinitis. Adjuvant therapy with MSL-109 was ineffective in clearing CMV-DNA and CMV antigen from the plasma.
确定巨细胞病毒（CMV）病毒血症与新诊断及复发的CMV视网膜炎患者死亡率及CMV视网膜炎进展之间的关联。
一项随机、安慰剂对照的III期临床试验的辅助研究。
在单克隆抗体CMV视网膜炎试验的第一阶段招募的83例患有艾滋病和CMV视网膜炎的患者，接受MSL-109或安慰剂作为CMV视网膜炎的辅助治疗。
死亡率和CMV视网膜炎进展。
MSL-109治疗并不能预测CMV视网膜炎的进展或死亡率。基线时血浆中CMV DNA的检测可预测死亡率，但CMV抗原血症则不能。CMV DNA比高HIV病毒载量更能预测死亡率。CMV DNA和抗原血症均不能预测CMV视网膜炎的进展。在新诊断的患者中，接受抗CMV治疗后，可检测到CMV病毒载量和CMV抗原血症的患者比例有所下降。然而，6个月时CMV病毒载量反弹至25%，CMV抗原血症反弹至54.6%。在复发患者中，抗CMV治疗与可检测到CMV-DNA或CMV抗原血症的百分比随时间的变化无关。
在患有艾滋病和CMV视网膜炎的患者中，血浆CMV DNA的检测与高HIV病毒载量相比，与更高的死亡风险相关。抗CMV治疗可使新诊断而非复发的CMV视网膜炎患者的CMV病毒血症暂时降低。MSL-109辅助治疗无法有效清除血浆中的CMV-DNA和CMV抗原。
