This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This prospective observational study is designed to characterize the incidence, magnitude, mechanisms, and consequences of postpartum viral rebound during the initial 24 weeks postpartum. Women will be enrolled at >22 but <30 weeks gestational age such that prepartum viral loads can be obtained that reflect the effect of stable antiretroviral therapy. This study will explore the mechanism(s) of this viral rebound by monitoring changes in adherence, drug exposure in a subgroup of subjects, and genotype viral resistance. This study will also quantify proviral DNA pre-and post-partum to rule out volume contraction as an etiologic mechanism of postpartum viral load increases, and assess whether prepartum HIV-specific cytotoxic T-lymphocyte (CTL) responses decrease the likelihood of postpartum viral rebound. Plasma HIV-1 RNA and CDR+ cell counts will be performed in real time while samples for HIV-1 genotyping, phenotyping, HLA class typing and CTL assays will be stored for possible later analyses. Follow-up postpartum will occur at 2, 6, 12, and 24 weeks, then every 12 weeks for a total of 96 weeks postpartum. The primary objective is to estimate the proportion of women who develop viral rebound at 24 weeks postpartum compared with the third trimester.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000032-46
Application #
7380442
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-03-01
Project End
2007-02-28
Budget Start
2006-03-01
Budget End
2007-02-28
Support Year
46
Fiscal Year
2006
Total Cost
$1,143
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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