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Article: Evaluating Diversity in Randomized Clinical Trials of Dolutegravir-Based Antiretroviral Therapy Regimens: Pooled 48-Week Analyses by Race, Sex, and Regional Subgroups.

Rawlings, M Keith / Letang, Emilio / Quercia, Romina / Grove, Richard / DeMasi, Ralph / Min, Sherene / Vannappagari, Vani / Zolopa, Andrew / van Wyk, Jean / Smith, Kimberly

Open forum infectious diseases

2022 Volume 9, Issue 8, Page(s) ofac304

Abstract: Background: In HIV clinical trials, proportions of Black and female participants achieving virologic suppression (VS) are often lower compared with White and male participants. As the antiretroviral therapy (ART) landscape continues to evolve, ... ...

Abstract	Background: In HIV clinical trials, proportions of Black and female participants achieving virologic suppression (VS) are often lower compared with White and male participants. As the antiretroviral therapy (ART) landscape continues to evolve, addressing existing challenges in clinical trial diversity will be critical to effectively translate results into clinical practice. Here, we pooled data to evaluate the efficacy and safety of dolutegravir (DTG)-containing regimens by race, sex, and regional subgroups. Methods: Three pooled analyses were conducted using 48-week results from phase 3/3b trials: DTG 3-drug vs non-DTG-containing 3- or 4-drug regimens in ART-naive participants (ARIA, FLAMINGO, SINGLE, SPRING-2), DTG-containing 2-drug vs 3-drug regimens in ART-naive participants (GEMINI-1, GEMINI-2), and DTG 3-drug vs non-DTG-containing 3- or 4-drug regimens in ART-experienced participants (SAILING, DAWNING). Proportions of participants with VS, safety, and change from baseline in CD4+ cell count were analyzed. Results: Proportions of participants achieving VS were high among those receiving DTG vs comparator regimens. Proportions of participants achieving VS were generally lower in Black (vs non-Black), female (vs male), and US (vs non-US) subgroups. No new safety signals emerged from any subgroup in pooled analyses. Conclusions: These analyses confirm that, across subgroups, DTG has robust efficacy and a good safety profile at week 48 relative to comparator regimens. Achieving VS may vary by participant characteristics, highlighting the urgent need for enrollment to reflect the demographics of global HIV populations more accurately. Future studies should strive to support participants throughout the trial to ensure optimal representation, inclusion, and retention.
Language	English
Publishing date	2022-06-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac304
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Article ; Online: Variation in Preferences for Long-Acting Injectable Pre-Exposure Prophylaxis Among US Men Who Have Sex with Men: A Latent Class Analysis.

Beckham, S Wilson / Sanchez, Travis / Fowler, Rebecca / Zlotorzynska, Maria / Rai, Mona / Sullivan, Patrick / Vannappagari, Vani / Sarkar, Supriya / Glick, Jennifer L / Rinehart, Alex R / Rawlings, Keith / Bridges, John F P

AIDS patient care and STDs

2023 Volume 37, Issue 10, Page(s) 495–503

Abstract: Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA PrEP) is efficacious, with a good safety profile, and was approved by the US Food and Drug Administration in December 2021. Understanding variations in potential user preferences for LA ...

Abstract	Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA PrEP) is efficacious, with a good safety profile, and was approved by the US Food and Drug Administration in December 2021. Understanding variations in potential user preferences for LA PrEP may inform implementation and subsequently improve uptake and community-level effectiveness. HIV-negative, sexually active men who have sex with men (MSM) aged ≥15 years were recruited online for the 2019 American Men's Internet Survey, before LA PrEP approval. Respondents completed a discrete-choice experiment (DCE) with hypothetical LA PrEP attributes (out-of-pocket cost, perceived side effects, injection frequency, perceived stigma, service location). Latent class analysis segmented respondents into groups based on their preferences for the attributes presented, and relative importance of preference weights and willingness-to-pay were calculated. While the majority had never used daily oral PrEP, 73% of the 2489 respondents were very or somewhat likely to use LA PrEP. Three latent classes were identified from 2241 respondents in the DCE. The "side effects-averse" class was the largest group (64% of respondents) and placed 61% relative importance on side effects. The "ambivalent" class (20% of respondents) placed higher importance on stigma (17% of relative importance) than other classes. The "cost-conscious" class (16% of respondents) placed higher relative importance (62%) on cost compared with other attributes and classes. Perceived side effects were an important hypothetical barrier for LA PrEP uptake among a large proportion of potential MSM users. Minimizing out-of-pocket costs is likely to increase uptake and may be important to equitable access. Tailored communication strategies are recommended for the different groups of potential LA PrEP users.
MeSH term(s)	Male ; Humans ; Homosexuality, Male ; HIV Infections/prevention & control ; HIV Infections/drug therapy ; Pre-Exposure Prophylaxis ; Latent Class Analysis ; Sexual and Gender Minorities ; Anti-HIV Agents/therapeutic use
Chemical Substances	Anti-HIV Agents
Language	English
Publishing date	2023-10-19
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1326868-5
ISSN	1557-7449 ; 0893-5068 ; 1087-2914
ISSN (online)	1557-7449
ISSN	0893-5068 ; 1087-2914
DOI	10.1089/apc.2023.0109
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Article: Comorbidities and challenges affecting African Americans with HIV infection.

Rawlings, M Keith / Masters, Henry L

Journal of the National Medical Association

2008 Volume 100, Issue 12, Page(s) 1477–1481

Abstract: The significant disparities in health outcomes that exist among racial minorities in the United States are clearly evident in the HIV epidemic. HIV disproportionately affects minorities, African Americans in particular. Current treatment of HIV/AIDS is ... ...

Abstract	The significant disparities in health outcomes that exist among racial minorities in the United States are clearly evident in the HIV epidemic. HIV disproportionately affects minorities, African Americans in particular. Current treatment of HIV/AIDS is complicated by medical problems such as hepatitis, diabetes and dyslipidemia, which also disproportionately affect African Americans and can significantly impact the complexity of clinical care. In addition, untreated psychological problems such as depression and societal barriers to adequate medical care may decrease treatment adherence and increase HIV-related morbidity and mortality among African Americans. Consideration of these issues by healthcare providers is necessary to optimize care and improve treatment outcomes for African Americans with HIV infection.
MeSH term(s)	African Americans/statistics & numerical data ; Anti-Retroviral Agents/therapeutic use ; Comorbidity ; Diabetes Mellitus, Type 2/ethnology ; HIV Infections/drug therapy ; HIV Infections/ethnology ; Humans ; Kidney Diseases/ethnology ; Liver Diseases/ethnology
Chemical Substances	Anti-Retroviral Agents
Language	English
Publishing date	2008-12-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	419737-9
ISSN	0027-9684
ISSN	0027-9684
DOI	10.1016/s0027-9684(15)31550-9
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Article ; Online: Oxidation of Protein Kinase A Regulatory Subunit PKARIα Protects Against Myocardial Ischemia-Reperfusion Injury by Inhibiting Lysosomal-Triggered Calcium Release.

Simon, Jillian N / Vrellaku, Besarte / Monterisi, Stefania / Chu, Sandy M / Rawlings, Nadiia / Lomas, Oliver / Marchal, Gerard A / Waithe, Dominic / Syeda, Fahima / Gajendragadkar, Parag R / Jayaram, Raja / Sayeed, Rana / Channon, Keith M / Fabritz, Larissa / Swietach, Pawel / Zaccolo, Manuela / Eaton, Philip / Casadei, Barbara

Circulation

2020 Volume 143, Issue 5, Page(s) 449–465

Abstract: Background: Kinase oxidation is a critical signaling mechanism through which changes in the intracellular redox state alter cardiac function. In the myocardium, PKARIα (type-1 protein kinase A) can be reversibly oxidized, forming interprotein disulfide ... ...

Abstract	Background: Kinase oxidation is a critical signaling mechanism through which changes in the intracellular redox state alter cardiac function. In the myocardium, PKARIα (type-1 protein kinase A) can be reversibly oxidized, forming interprotein disulfide bonds in the holoenzyme complex. However, the effect of PKARIα disulfide formation on downstream signaling in the heart, particularly under states of oxidative stress such as ischemia and reperfusion (I/R), remains unexplored. Methods: Atrial tissue obtained from patients before and after cardiopulmonary bypass and reperfusion and left ventricular (LV) tissue from mice subjected to I/R or sham surgery were used to assess PKARIα disulfide formation by immunoblot. To determine the effect of disulfide formation on PKARIα catalytic activity and subcellular localization, live-cell fluorescence imaging and stimulated emission depletion super-resolution microscopy were performed in Results: In both humans and mice, myocardial PKARIα disulfide formation was found to be significantly increased (2-fold in humans, Conclusions: Disulfide modification targets PKARIα to the lysosome, where it acts as a gatekeeper for two-pore channel-mediated triggering of global calcium release. In the postischemic heart, this regulatory mechanism is critical for protection from extensive injury and offers a novel target for the design of cardioprotective therapeutics.
MeSH term(s)	Animals ; Calcium/metabolism ; Cyclic AMP-Dependent Protein Kinase RIalpha Subunit/metabolism ; Cyclic AMP-Dependent Protein Kinases/metabolism ; Humans ; Mice ; Myocardial Reperfusion Injury/therapy ; Oxidation-Reduction
Chemical Substances	Cyclic AMP-Dependent Protein Kinase RIalpha Subunit ; Cyclic AMP-Dependent Protein Kinases (EC 2.7.11.11) ; Calcium (SY7Q814VUP)
Language	English
Publishing date	2020-11-13
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIRCULATIONAHA.120.046761
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Article ; Online: Testing the Equivalence between Spatial Averaging and Temporal Averaging in Highly Dilute Solutions.

Carroll, Keith M / Rawlings, Colin / Zhang, Yadong / Knoll, Armin W / Marder, Seth R / Wolf, Heiko / Duerig, Urs

Langmuir : the ACS journal of surfaces and colloids

2017 Volume 33, Issue 51, Page(s) 14539–14547

Abstract: Diffusion relates the flux of particles to the local gradient of the particle density in a deterministic way. The question arises as to what happens when the particle density is so low that the local gradient becomes an ill-defined concept. The dilemma ... ...

Abstract	Diffusion relates the flux of particles to the local gradient of the particle density in a deterministic way. The question arises as to what happens when the particle density is so low that the local gradient becomes an ill-defined concept. The dilemma was resolved early last century by analyzing the average motion of particles subject to random forces whose magnitude is such that the particles are always in thermal equilibrium with their environment. The diffusion dynamics is now described in terms of the probability density of finding a particle at some position and time and the probabilistic flux density, which is proportional to the gradient of the probability density. In a time average sense, the system thus behaves exactly like the ensemble average. Here, we report on an experimental method and test this fundamental equivalence principle in statistical physics. In the experiment, we study the flux distribution of 20 nm radius polystyrene particles impinging on a circular sink of micrometer dimensions. The particle concentration in the water suspension is approximately 1 particle in a volume element of the dimension of the sink. We demonstrate that the measured flux density is exactly described by the solution of the diffusion equation of an infinite system, and the flux statistics obeys a Poissonian distribution as expected for a Markov process governing the random walk of noninteracting particles. We also rigorously show that a finite system behaves like an infinite system for very long times despite the fact that a finite system converges to a zero flux empty state.
Language	English
Publishing date	2017--26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2005937-1
ISSN	1520-5827 ; 0743-7463
ISSN (online)	1520-5827
ISSN	0743-7463
DOI	10.1021/acs.langmuir.7b02730
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Article: Managing the metabolic and morphologic complications of HIV.

Rawlings, M Keith / Santos, Guillermo

Journal of the National Medical Association

2004 Volume 96, Issue 2 Suppl, Page(s) 17S–20S

MeSH term(s)	HIV Infections/complications ; Humans ; Metabolic Diseases/etiology ; Metabolic Diseases/therapy ; Wasting Syndrome/etiology ; Wasting Syndrome/therapy ; Weight Loss
Language	English
Publishing date	2004-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	419737-9
ISSN	0027-9684
ISSN	0027-9684
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Article ; Online: The electronic Rothamsted Archive (e-RA), an online resource for data from the Rothamsted long-term experiments.

Perryman, Sarah A M / Castells-Brooke, Nathalie I D / Glendining, Margaret J / Goulding, Keith W T / Hawkesford, Malcolm J / Macdonald, Andy J / Ostler, Richard J / Poulton, Paul R / Rawlings, Christopher J / Scott, Tony / Verrier, Paul J

Scientific data

2018 Volume 5, Page(s) 180072

Abstract: The electronic Rothamsted Archive, e-RA (www.era.rothamsted.ac.uk) provides a permanent managed database to both securely store and disseminate data from Rothamsted Research's long-term field experiments (since 1843) and meteorological stations (since ... ...

Abstract	The electronic Rothamsted Archive, e-RA (www.era.rothamsted.ac.uk) provides a permanent managed database to both securely store and disseminate data from Rothamsted Research's long-term field experiments (since 1843) and meteorological stations (since 1853). Both historical and contemporary data are made available via this online database which provides the scientific community with access to a unique continuous record of agricultural experiments and weather measured since the mid-19
Language	English
Publishing date	2018-05-15
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2775191-0
ISSN	2052-4463 ; 2052-4463
ISSN (online)	2052-4463
ISSN	2052-4463
DOI	10.1038/sdata.2018.72
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Article: Recognizing and managing common toxicities in patients receiving antiretroviral therapy.

Rawlings, M Keith / Smith, Kimberly Y

The AIDS reader

2004 Volume 14, Issue 10 Suppl, Page(s) S12–5

Abstract: Each of the 3 traditional classes of antiretroviral drugs (nucleoside/nucleotide reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, and protease inhibitors [PIs]) has characteristic sets of toxicities that are not found ... ...

Abstract	Each of the 3 traditional classes of antiretroviral drugs (nucleoside/nucleotide reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, and protease inhibitors [PIs]) has characteristic sets of toxicities that are not found with the other drug classes. On the other hand, lipodystrophy, which was thought to be specific to PIs, is now known to be common to all 3 classes of drugs. An understanding of the drug-specific, class-specific, and general toxicities and side effects of antiretroviral drugs will help the clinician tailor treatment regimens to individual patients.
MeSH term(s)	African Americans ; Female ; HIV Infections/drug therapy ; Hispanic Americans ; Humans ; Male ; Protease Inhibitors/adverse effects ; Reverse Transcriptase Inhibitors/adverse effects
Chemical Substances	Protease Inhibitors ; Reverse Transcriptase Inhibitors
Language	English
Publishing date	2004-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2039813-X
ISSN	1053-0894
ISSN	1053-0894
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Article: Testing the Equivalence between Spatial Averaging and Temporal Averaging in Highly Dilute Solutions

Carroll, Keith M / Armin W. Knoll / Colin Rawlings / Heiko Wolf / Seth R. Marder / Urs Duerig / Yadong Zhang

Langmuir. 2017 Dec. 26, v. 33, no. 51

2017

Abstract	Diffusion relates the flux of particles to the local gradient of the particle density in a deterministic way. The question arises as to what happens when the particle density is so low that the local gradient becomes an ill-defined concept. The dilemma was resolved early last century by analyzing the average motion of particles subject to random forces whose magnitude is such that the particles are always in thermal equilibrium with their environment. The diffusion dynamics is now described in terms of the probability density of finding a particle at some position and time and the probabilistic flux density, which is proportional to the gradient of the probability density. In a time average sense, the system thus behaves exactly like the ensemble average. Here, we report on an experimental method and test this fundamental equivalence principle in statistical physics. In the experiment, we study the flux distribution of 20 nm radius polystyrene particles impinging on a circular sink of micrometer dimensions. The particle concentration in the water suspension is approximately 1 particle in a volume element of the dimension of the sink. We demonstrate that the measured flux density is exactly described by the solution of the diffusion equation of an infinite system, and the flux statistics obeys a Poissonian distribution as expected for a Markov process governing the random walk of noninteracting particles. We also rigorously show that a finite system behaves like an infinite system for very long times despite the fact that a finite system converges to a zero flux empty state.
Keywords	equations ; Markov chain ; physics ; polystyrenes ; probability distribution
Language	English
Dates of publication	2017-1226
Size	p. 14539-14547.
Publishing place	American Chemical Society
Document type	Article
ZDB-ID	2005937-1
ISSN	1520-5827 ; 0743-7463
ISSN (online)	1520-5827
ISSN	0743-7463
DOI	10.1021/acs.langmuir.7b02730
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Impact of comorbidities and drug therapy on development of renal impairment in a predominantly African American and Hispanic HIV clinic population

M Keith Rawlings / Jennifer Klein / Edna P Toubes Klingler

HIV/AIDS : Research and Palliative Care, Vol 2011, Iss default, Pp 1-

2011 Volume 8

Abstract: M Keith Rawlings1, Jennifer Klein1, Edna P Toubes Klingler1, Ejeanée Queen1, Lauren Rogers1, Linda ... H Yau2, Keith A Pappa2, Gary E Pakes21AIDS Arms Peabody Health Clinic, Dallas, Texas ...

Abstract	M Keith Rawlings1, Jennifer Klein1, Edna P Toubes Klingler1, Ejeanée Queen1, Lauren Rogers1, Linda H Yau2, Keith A Pappa2, Gary E Pakes21AIDS Arms Peabody Health Clinic, Dallas, Texas; 2GlaxoSmithKline, Research Triangle Park, North Carolina, USAPurpose: Renal impairment in human immunodeficiency virus (HIV)-infected patients could potentially be caused by many factors. HIV-related renal impairment risks have been little studied in African Americans and Hispanics. We investigated the impact of HIV itself, highly active antiretroviral therapy (HAART), comorbidities, and non-HIV-related drug treatment on glomerular filtration rate in a predominantly African American/Hispanic HIV-infected population who had received HAART for at least one year. This study was a retrospective electronic medical record database evaluation of renal impairment risks in a largely African American/Hispanic HIV population obtaining medical care at an HIV clinic in Dallas, Texas.Methods: Proportional hazards models were used to investigate an association between an estimated glomerular filtration rate decrease >25% from baseline (ie, renal impairment) and demographics, antiretroviral/nonantiretroviral medications, comorbidities (hypertension, diabetes mellitus, hepatitis C virus [HCV] infection, hepatitis B virus [HBV] infection), CD4+ counts, viral load, and duration patients were monitored at the clinic (time on study).Results: In total, 323 patients were evaluated: 82% males; 61% African American/12% Hispanic/19% Caucasian; mean age 37.9 years (standard deviation [SD] 8.5); 6% HBV-positive; 34% HCV-positive; 29% hypertensive; 3% diabetic; 52% tenofovir-treated; mean weight 75.4 kg (SD, 15.4); mean estimated glomerular filtration 114.5 mL/min/1.73 m2 (SD, 36.7) using the Modification of Diet in Renal Disease (MDRD) calculation method; mean creatinine clearance (from which estimated glomerular filtration was extrapolated) by the Cockcroft-Gault calculation method 120.6 mL/min/1.73 m2 (SD, 41.2); mean time on study 2.7 years (SD, 1.0 year). An estimated glomerular filtration rate decrease of . >25% from baseline was significantly associated with time on study (P = 0.0017; hazards ratio [HR] = 0.999) and hypertension (HR = 1.706; P = 0.0158) by the MDRD method, and with age (HR = 1.039; P = 0.0077), weight (HR = 0.987; P = 0.0023), and time on study (HR = 0.999; P = 0.0043) by extrapolation of Cockcroft-Gault creatinine clearance calculation. No specific HAART agent was associated with significant renal impairment risk by the definition used in this study.Conclusion: This retrospective database study showed time on study, hypertension, weight, and age to be the only significant predictors of an estimated glomerular filtration rate decrease >25% from baseline.Keywords: nephropathy, antiretroviral therapy, comorbidities, tenofovir, African American, Hispanic
Keywords	Immunologic diseases. Allergy ; RC581-607 ; Specialties of internal medicine ; RC581-951 ; Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Allergy and Immunology ; DOAJ:Medicine (General) ; DOAJ:Health Sciences ; Medicine (General) ; R5-920
Subject code	616
Language	English
Publishing date	2011-01-01T00:00:00Z
Publisher	Dove Medical Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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