FOLLOW UP OF WOMEN PARTICIPATING IN ACTG 076
FOLLOW UP OF WOMEN PARTICIPATING IN ACTG 076
批准号:
6114335
负责人:
ANDREA JENAY RUFF
金额:
$2.06万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30
关键词:
AIDS therapy antibody formation biomarker clinical research female human mortality human pregnant subject human therapy evaluation longitudinal human study outcomes research pathologic process polymerase chain reaction postpartum pregnancy disorder chemotherapy pregnancy infection quality of life virus load women's health zidovudine
中文摘要
本研究的目的是评估临时ZDV的影响
怀孕期间服用对妇女随后的健康有影响。 的
主要关注疾病进展的临床参数,
生存率,次要评价包括生活质量,
免疫力下降 此外,
3年内耐药的病毒学标志物(密码子215/41突变)
在妊娠结束后停用ZDV后,
在ACTG 076的女性亚组中进行了评估,
样品从交付是可用的。 病毒负荷评价,测量
通过HIV-RNA PCR,在ZDV停药后的3年内,
也可以在相同的子集中执行。 此外,病毒学分析
将对所有储存的细胞进行耐药性和病毒载量的检测,
入组受试者为产后12个月。
英文摘要
The goals of this study are to assess the impact of temporary ZDV
administration during pregnancy on the subsequent health of women. The
major focus is on clinical parameters of disease progression and
survival, with secondary evaluations including quality of life and
immunologic decline. In addition, the incidence and persistence of a
virologic marker of resistance (codon 215/41 mutation) in the 3 years
following discontinuation of ZDV after pregnancy completion will be
assessed in the subset of women in ACTG 076 from whom a stored viral
sample from delivery is available. Evaluation of viral burden, measured
by HIV-RNA PCR, over the 3 years following discontinuation of ZDV will
also be performed in the same subset. In addition, virologic analysis
of resistance and viral load will be performed on stored cells in all
enrolled subjects as 12 months postpartum.
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