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Arlington, VA, United States

Bansil P.,CONRAD
Journal of women's health (2002) | Year: 2010

To compare maternal and fetal outcomes among women with and without diagnosed depression at the time of delivery. Hospital discharge data from the 1998-2005 Nationwide Inpatient Sample (NIS) were used to examine delivery-related hospitalizations for select maternal and fetal outcomes by depression diagnosis. The rate of depression per 1000 deliveries increased significantly from 2.73 in 1998 to 14.1 in 2005 (p < 0.001). Women diagnosed with depression were significantly more likely to have cesarean delivery, preterm labor, anemia, diabetes, and preeclampsia or hypertension compared with women without depression. Fetal outcomes significantly associated with maternal depression were fetal growth restriction, fetal abnormalities, fetal distress, and fetal death. These findings suggest that depression is associated with adverse maternal and fetal outcomes. Our results provide additional impetus to screen for depression among women of reproductive age, especially those who plan to become pregnant.


Richardson-Harman N.,Alpha StatConsult LLC | Mauck C.,CONRAD | McGowan I.,University of Pittsburgh | Anton P.,University of California at Los Angeles
AIDS Research and Human Retroviruses | Year: 2012

A retrospective correlational analysis of UC781 (0.1, 0.25%) gel pharmacokinetics (PK) and pharmacodynamics (PD) was undertaken using data generated in the RMP-01/MTN-006 Phase 1 rectal safety study of the UC781 microbicide gel, where strong UC781-related inhibition of ex vivo biopsy infectibility (PD) was seen. Precision analysis, linear and logistical correlational methods were applied to model the dose-response relationship. Four analyses of explant virus growth were compared to determine tissue concentrations of UC781 needed to maintain ex vivo virus growth below a range of cut-points. SOFT, a cross-sectional index from a growth curve, and cumulative p24 endpoints were the most precise measurement of ex vivo HIV infection and significantly (p<0.01) correlated with rectal tissue UC781 concentrations. Cut-points reflecting infectibility, ranging from 200 to 1300 p24pg/ml, provided EC50,90,95 tissue levels of UC781. A cut-point of 200 p24pg/ml provided an EC50 of 2148 UC781ng/g tissue; a cut-point of 1100 p24 predicted a lower EC50 of 101 UC781ng/g. A 30- to 170-fold EC 90:EC50 ratio was found. Higher p24 cut-points provided more predictive models. Tissue UC781 levels and ex vivo infectibility data were correlated to model dose-response drug efficacy in this small Phase 1 trial. Logistic regression analyses showed EC50,90,95 values were inversely related to p24 cut-point levels, providing clinically relevant insights into tissue drug concentration necessary for ex vivo suppression of HIV tissue infectibility. This first PK-PD assessment of topical microbicides demonstrates feasibility in Phase 1 trials, enabling comparisons of microbicide efficacy (i.e., EC50,90,95) between formulations, compartments, and application methods. © Copyright 2012, Mary Ann Liebert, Inc.


Patent
Conrad and International Partnership For Microbicides | Date: 2010-09-24

The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid (tenofovir, PMPA), or a physiologically functional derivative thereof, suitable for topical application and their use in the prevention of HIV infections.


Patent
Conrad and International Partnership For Microbicides | Date: 2010-09-29

The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid (tenofovir, PMPA), or a physiologically functional derivative thereof, suitable for topical application and their use in the prevention of HIV infections.


The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-pur: in-9-yl)-1-methyl-ethoxymethy]-phosphonic acid (tenofivir, PMPA), or a physiologically functional derivative thereof, wherein the formulations contain a low level of glycerin. Human immunodeficiency vims (HIV) infection and related diseases are a major public health problem worldwide. One approach to the problem of HIV/AIDS is to reduce the risk of transmission of HIV and thus reduce the number of individuals who become newly infected.

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