Publications by authors named "J P Rooney"

Article Synopsis
  • Introduction of long-acting injectable cabotegravir (CAB-LA) for HIV prevention showed effectiveness, and this study examines its safety and pharmacokinetics in pregnant women participating in the HPTN 084 trial during a blinded period.
  • In the study, pregnant participants were divided into two groups receiving either CAB-LA or TDF/FTC, with careful monitoring of pregnancy outcomes and maternal adverse events, finding that there was no significant difference in adverse event rates or poor pregnancy outcomes between the two groups.
  • The analysis revealed a total of 57 confirmed pregnancies over 3845 person-years, with 81% resulting in live births, and the study concluded that CAB-LA did not result in significantly different safety or outcomes
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Background: Tenofovir disoproxil fumarate (TDF) when used as preexposure prophylaxis (PrEP) in pregnancy is considered safe overall however there is insufficient evidence of its effect on maternal bone. We compared bone mineral density (BMD) and content (BMC) at the lumbar spine (LS) and hip of African breastfeeding women exposed and not exposed to TDF-containing PrEP in a randomized control trial (RCT).

Methods: This is a secondary data analysis of an RCT where pregnant women were randomized to initiating PrEP in pregnancy or delayed initiation of PrEP until breastfeeding cessation.

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Background: Sexually transmitted infections (STIs) have been shown to facilitate HIV transmission and acquisition. HPTN 083, a global clinical trial, demonstrated superiority of long-acting cabotegravir (CAB-LA) versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV prevention among transgender women and cisgender men who have sex with men. This analysis assessed whether CAB-LA maintained protective efficacy when bacterial STIs (syphilis, rectal/urethral gonorrhea and chlamydia) were present.

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Introduction: Tenofovir disoproxil fumarate (TDF) is a common drug of choice for pre-exposure prophylaxis (PrEP) or as a combination HIV treatment for pregnant women. In-utero exposure to TDF was found to be associated with lower bone mineral content (BMC) in HIV-exposed uninfected neonates. Data for infants born to women taking TDF-PrEP are lacking.

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There is a pressing need to increase the efficiency and reliability of toxicological safety assessment for protecting human health and the environment. While conventional toxicology tests rely on measuring apical changes in vertebrate models, there is increasing interest in the use of molecular information from animal and in vitro studies to inform safety assessment. One promising and pragmatic application of molecular information involves the derivation of transcriptomic points of departure (tPODs).

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