This will be a prospective single-center interventional trial to compare the outcomes of HIV-positive heart transplant recipients by the HIV status of the donor; HIV-positive vs. HIV-negative and learn whether heart organ transplantation from HIV+ deceased donors is as safe and effective in HIV+ recipients as transplants from HIV- deceased donors.
Patient will undergo standard evaluation for eligibility of transplantation by the primary heart transplant team. If patient meets eligibility criteria, they will be informed about the study and consent will be obtained. Informed consent will be obtained in a private clinic or inpatient hospital room in a confidential setting. HIV-positive or HIV-negative offers will be made by Organ Procurement and Transplantation Network (OPTN) (serving as a means of "natural randomization" and this information will also be collected, along with the information regarding any information for primary offer declines from the patients as well as other clinical indications to decline an organ offer. As a result of this, there will be two main groups in the study participants that will undergo analysis:
1. patients/recipients that are HIV+ who receive an organ from an HIV+ donor (HIV D+/R+ group)
2. patients/recipients that are HIV+ who receive an organ from an HIV negative donor (HIV D-/R+ group)
Only study participants will be able to receive organ offers from both HIV-positive and HIV-negative organ donors whichever is available first regardless of HIV status. This is the only study intervention. Baseline visit parameters will be obtained during a routine heart transplant visit. There will be no additional procedures or blood collection after the baseline study visit.
Study data will be collected from chart review of routine post-transplant follow-up visits at weeks 52 (1 year), 104 (2 years), and 152 (3 years) after the transplant.

Start Date01 Dec 2024

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

NCT05973825 / Not yet recruitingNot ApplicableIIT

Immuno-virological Evaluation of Persons Living With HIV (PLWH) Who Initiated Anti-retroviral Treatment (ART) During Acute HIV Infection and of PLWH on Long Term ART

This is a dual arm (arm 1 and arm 2) multi-centric non-randomized (prospective) study.
Two new multicentric cohorts will be set up in 4 Belgian HIV reference centers (UZ Gent, UZ Brussel, University Hospital Liege and St. Pierre Hospital Brussels): cohort 1 will comprise PLWH in whom ART was initiated during acute HIV infection minimum 3 years ago but no more than 10 years ago (short-term ART cohort); cohort 2 will comprise PLWH on ART since >20 years (long-term ART cohort). Participants will be included based on suppressed viremia and uninterrupted ART since initiation. Participants will undergo one blood sampling and one leukapheresis. In and exclusion criteria are described below.

Start Date01 Sep 2024

Sponsor / Collaborator

Ghent University Hospital

[+5]

NCT06560970 / Not yet recruitingNot ApplicableIIT

A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV

Older people with HIV (OPH) often live with significant mental health challenges such as social isolation, loneliness, and depression. The objectives of this study are to develop and test the usability and feasibility of a technology-based psychosocial intervention program designed to: enhance social engagement and support; facilitate resource access and education; reduce loneliness; and improve well-being among older adults with HIV who are long-term survivors (diagnosed with HIV ≥ 20 years). The program, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), will build on Dr. Sara Czaja's PRISM (A Personal Reminder and Information Management System for Seniors) platform, and will be an easy-to-use software application (app), preloaded onto a standard device, designed to support social connectivity, memory, and access to resources for older adults at risk for isolation and the programs and services available at the Center for Special Studies (CSS) at Weill Cornell Medicine (WCM). This protocol covers Phase 2 of the study, which will be a pilot randomized controlled efficacy trial will compare the COPPEhR intervention to a device-only control condition. Participants in the control condition will receive the same device as those in the COPPEhR condition without the COPPEhR application. The specific aims of this developmental project are to evaluate the feasibility, usefulness, and usability of a state-of-the art technology-based multicomponent COPPEhR intervention for aging adults with HIV. ;Our hypothesis is the COPPEhR intervention will be feasible, usable and useful. The hypothesis is that those that use the COPPEhR app will experience less loneliness, less depression, and less social isolation and more social support, more resilience, and more connectivity than those that do not use the COPPEhR app.

Start Date01 Aug 2024

Sponsor / Collaborator

Weill Medical College of Cornell University

100 Clinical Results associated with HIV Seropositivity

100 Translational Medicine associated with HIV Seropositivity

0 Patents (Medical) associated with HIV Seropositivity

851

Literatures (Medical) associated with HIV Seropositivity

01 Mar 2024·Enfermedades infecciosas y microbiologia clinica (English ed.)

Epidemiological characteristic and prognosis changes in chronic hepatitis B in people living with HIV

Article

Author: Montejano Sanchez, Rocío ; De Gea Grela, Alejandro ; Micán, Rafael ; Arribas, Jose Ramón ; Serrano, Lucía ; de Miguel Buckley, Rosa ; Moreno, Victoria ; Valencia, María Eulalia ; Martín-Carbonero, Luz ; Ramos Ruperto, Luis ; Busca Arenzana, Carmen ; González, Juan ; Montes, María Luisa ; Vásquez Manau, Julia ; Marcelo Calvo, Cristina ; Bernardino, Ignacio

INTRODUCTIONDue to hepatitis B virus (HBV) treatment and vaccination during the last decades in Spain, epidemiological and prognosis of chronic hepatitis B (CHB) may have changed.METHODSRetrospective review of CHB-HIV coinfected patients in a single reference center in Madrid until year 2019. We compared incidence, epidemiological and clinical characteristics according diagnosis period (before 2000, 2000-2004, 2005-2009, 2010-2014, 2015-2019). A retrospective longitudinal study was done to assess mortality, related risk factors and hepatic decompensation.RESULTSOut of 5452 PLHIV, 160 had CHB (prevalence 2.92%; 95%CI 2.5-3.4), 85.6% were men, median age 32.1 (27-37.2). Incidence rate did not change over the years (2.4/100 patients-year). PLHIV with CHB diagnosed before year 2000 (n = 87) compared with those diagnosed between 2015 and 2019 (n = 11) were more often native-Spanish (90.8% vs. 18.2%), had infected using intravenous drugs (55.2% vs. 0), were coinfected with hepatitis C (40% vs. 9.1%) or hepatitis delta virus (30.4% vs. 0) and had more severe liver disease (cirrhosis 24.1% vs. 0). After a median follow-up of 20.4 years, 23 patients died (7.1/1000 patients-year) and 19 had liver decompensation (4.9/1000 patients-year). All deaths and liver decompensation occurred in patients diagnosed before year 2010. Mortality was associated with higher liver fibrosis in Fibroscan® (HR 1.06, 95% CI 1.03-1.09).CONCLUSIONThe epidemiology of CHB in PLHIV in our cohort is changing with less native Spanish, more sexually transmitted cases and less coinfection with other hepatotropic virus. Patients diagnosed before 2010 have worst prognosis related to higher grades of liver fibrosis.

03 Nov 2023·Current HIV Research

Analysis of the Efficacy of Drilling Decompression Autologous Bone Marrow and Allogeneic Bone Grafting in the Treatment of HIV-positive Patients with Early Osteonecrosis of the Femoral Head

Article

Author: Changsong, Zhao ; Shengtao, Li ; Zhengrong, Gao ; Xuemin, Quan ; Qiang, Zhang ; Jie, Wang ; Rui, Ma ; Min, He ; Yu, Pu

Objective::To investigate the efficacy of treating patients with HIV-positive osteonecrosis of the femoral head using drilled decompression autologous bone marrow and allogeneic bone grafting.To investigate the efficacy of treating patients with HIV-positive osteonecrosis of the femoral head using drilled decompression autologous bone marrow and allogeneic bone grafting.Methods::40 patients (44 hips) with early osteonecrosis of the femoral head treated by drilling decompression autologous bone marrow and allogeneic bone grafting since October 2015 were retrospectively analyzed, among which 20 patients (24 hips) were HIV-positive patients with early osteonecrosis of the femoral head, 16 males and 4 females, age 22-43 years, average 39.6±10.18 years, and 20 patients (20 hips) in the same period HIV-negative early osteonecrosis of the femoral head patients, 13 males and 7 females, aged 48-78 years, mean 63.50±7.94 years were negative controls. General information including ARCO stage, Harris score, VAS score, hematological indexes including CD4+ T lymphocyte count, and HIV viral load was recorded for all patients before surgery. All patients were operated on by drilling and decompression of the necrotic area, harvesting autologous iliac bone marrow with allogeneic bone, and bone grafting through the decompression channel. The patients were followed up regularly at 6, 12, and 24 months after surgery and annually thereafter, and the repair of the necrotic femoral head was observed by reviewing the frontal and lateral X-ray, CT or MRI of the hip joint, and the complications and functional recovery of the hip joint was counted and compared between the two groups.Results::All patients were followed up, and the ARCO stages in the HIV-positive group were stage I 2 hips, stage IIA 6 hips, stage IIB 8 hips, stage IIC 6 hips, and stage III 2 hips, with a follow- up time of 12 to 60 months and a mean of 24.6 months. In the negative control group, there were 3 hips in ARCO stage I, 7 hips in stage IIA, 5 hips in stage IIB, 3 hips in stage IIC, and 2 hips in stage III, and the follow-up time ranged from 13 to 62 months, with an average of 24.8 months. The Harris score and VAS score of the hip in both groups improved significantly at 6 months after surgery compared with those before surgery (P < 0.05). The difference between the Harris score of the hip in the positive group at 2-year after surgery compared with that at 6 months after surgery was statistically significant, but the VAS score at 2-year after surgery compared with that at 6 months after surgery was not statistically significant. In the negative group, there was no statistically significant difference in the Harris score and VAS score of the hip at 2 years after surgery compared with those at 6 months after surgery. In the positive group, there was a trend of continuous increase in hip BMD from the beginning of the postoperative period (P < 0.05). There was no statistically significant difference between the negative group and the positive group at the 2-year postoperative follow-up except for the Harris score, which was statistically significant (P < 0.05), and the VAS score, which was statistically insignificant (P > 0.05). At the 2-year postoperative follow-up, patients in both groups had good recovery of hip function, and no complications such as vascular and nerve injury and fracture occurred during the perioperative period and follow-up period, and no complications related to incisional infection and pulmonary infection occurred during hospitalization.Conclusion::Drilling and decompression to remove the necrotic area of the femoral head and performing autologous bone marrow and allogeneic bone grafting for patients with early-stage HIV-- positive osteonecrosis of the femoral head can effectively stop the progression of femoral head necrosis in HIV-positive patients, delay the arthroplasty of joint replacement, and promote the repair of the femoral head, which is a safe and effective method of treatment for early-stage HIV-positive femoral head necrosis patients.

01 Oct 2023·International journal of radiation oncology, biology, physics

A Comparative Analysis of Effect of HIV Infection on Outcomes of Cervical Cancer Treated with Radiotherapy.

Article

Author: Shah, S Patel ; Ratanchandani, K K ; Bhuvana, J ; Kulshrestha, A ; Kunikullaya, S ; Parikh, A

PURPOSE/OBJECTIVE(S)There is paucity of data on management of human immunodeficiency virus (HIV) positive cervical cancer and its clinical outcomes in Indian women. The primary objective of this study was to compare disease free survival (DFS) and overall survival (OS) between HIV-positive and HIV-negative patients receiving radiotherapy (RT) for cervical cancer. The secondary endpoints were toxicity and various factors affecting DFS and OS.MATERIALS/METHODSPatients diagnosed with cervical cancer on histopathology and treated with RT with or without concomitant chemotherapy (CT) at an institution between 2015 and 2020 were included in this retrospective analysis. On the basis of HIV serology test, 70 patients were included in each arm, Arm A had HIV-negative patients and Arm B had HIV-positive patients. In both the arms, external beam radiotherapy (EBRT) in adjuvant or radical setting was given with a total dose of 46-50 Gy to whole pelvis and iliac nodes; 2 Gy/fraction daily as 5 fractions/week by conventional four-field box technique or conformal 3-dimensional radiotherapy (3DCRT) or Intensity modulated radiotherapy (IMRT). Concurrent cisplatin was administered as weekly 40mg/m2 to patients with ECOG< = 2, creatinine clearance >40mL/min in radical and adjuvant patients as indicated. CD4 counts ≥200 cells/mm3 was a prerequisite for concurrent cisplatin in Arm B. Intracavitary or interstitial brachytherapy was delivered as indicated. Statistical analysis was done using statistical software. Kaplan-Meier method used for all survival analysis. Log rank test was used to calculate statistical significance for various prognostic factors followed by Cox regression test for multivariate analysis.RESULTSMedian age was 46.5 years (range: 30-76). In Arm A, 62 patients (88.57%) and 5 patients (7.14%) received radical and adjuvant RT. In Arm B 61 patients (87.14%) and 2 patients (2.85%) were given radical and adjuvant RT. 66 patients (94.28%) in Arm A and 52 patients (74.28%) in Arm B received concurrent cisplatin. At a median follow up of 33.8 months (range: 1.2 to 85.4), 2-year DFS was 88.9% for Arm-A and 86.5% for Arm-B (p = 0.134) and 2-year OS was 91.4% and 82.9% for Arm-A and Arm-B (p = 0.001), respectively. Grade III/IV skin toxicity was seen in and 4 patients (5.71%) in Arm A and 12 patients (17.14%) in Arm B (p = 0.34). Grade III/IV gastrointestinal toxicity was seen in 2(2.85%) patients and 4(5.7%) patients in Arm A and Arm B respectively (p = 0.40). 14(20%) patients in Arm A and 27(38.5%) patients in Arm B had Grade III/IV hematologic toxicity (p = 0.016). On multivariate analysis, anemia (Hb≤12 gm/dl) and OTT ≥56 days were associated with unfavorable DFS (p = 0.03 and p = 0.001) and OS (p = 0.04 and p = 0.01) in Arm B.CONCLUSIONIn view of comparable DFS outcomes in both the arms, HIV-positive cervical cancer patients can be managed with the standard treatment protocol as HIV-negative patients. HIV-positive patients are more likely to experience poorer DFS and OS. However, results need to be validated on prospective study.

News (Medical) associated with HIV Seropositivity

27 Oct 2023

·www.prnewswire.com

George Washington University Webinar to Discuss Combatting Clinician Burnout with Emergent Infections

Training series highlights solutions for HIV, PrEP/PEP and COVID-19 vaccine screenings in primary care WASHINGTON, Oct. 27, 2023 /PRNewswire/ -- The George Washington University School of Medicine and Health Sciences (SMHS) is hosting a free webinar on November 1st to discuss the issue of clinician burnout and how it can be addressed through emergent infections. The webinar is a part of a training series for the Two in One: HIV + COVID Screening and Testing Model, a national medical education program, and will feature Leon McCrea II, MD, MPH, senior associate dean of diversity, equity and inclusion at Drexel University, and Annette Gadegbeku, MD, associate dean of community health at Drexel University College of Medicine and an associate professor in the department of family, community & preventive medicine and chief of the division of community health. "Clinician burnout is one of the biggest issues facing healthcare today and it became exacerbated with the COVID-19 pandemic," said Maranda Ward, EdD, MPH, principal investigator of the Two in One Model and assistant professor of clinical research and leadership at GW SMHS. "Recognizing clinician burnout is the first step in addressing the issue, but we also need to understand the emerging threats that clinicians may face in the future and be ready with strategies to protect clinicians." The event is entitled "Combating PCP Burnout with Emergent Infections." During the webinar, attendees will learn about emergent infections that clinicians have had to become familiar with; learn how to recognize signs of clinician burnout; and list strategies to combat clinician burnout through addressing a range of emergent infections. The webinar is scheduled for November 1, from 12 – 1 p.m. ET. Anyone can register for the event here. This is the ninth webinar in the Two in One Model training series, which utilizes a combined health and racial equity lens to provide primary care practitioners the tools to routinize HIV, PrEP/PEP, and COVID vaccine screenings for all patients and to better engage in culturally responsive communication with their minoritized patients. The series includes nine live-streamed continuing medical education (CME) lectures as well as an asynchronous CME-bearing module-based training course and Patient Care toolkit. The program is actively engaged in formulating policy recommendations for adjusting clinical guidelines on COVID vaccine, HIV and PrEP/PEP screenings. This program has been supported by an independent educational grant from Gilead Sciences, Inc. For more information on this research-informed model, visit the Two-in-One website at: twoinone.smhs.gwu.edu. SOURCE The George Washington University School of Medicine and Health Sciences

VaccineClinical Study

11 Oct 2023

·www.prnewswire.com

George Washington University Webinar to Share Tips for Improving Patient Communication Through Language and Literacy

Training series highlights solutions for HIV, PrEP/PEP and COVID-19 vaccine screenings in primary care WASHINGTON, Oct. 11, 2023 /PRNewswire/ -- The George Washington University School of Medicine and Health Sciences (SMHS) is hosting a free webinar on October 25 to discuss culturally responsive communication in the primary care setting. The webinar is a part of a training series for the Two in One: HIV + COVID Screening and Testing Model, a national medical education program, and will feature Joaquín Carcaño, director of community organizing at the Latino Commission on AIDS. "Primary care practitioners need to ensure that they are meeting patients where they are, and are aware of language and literacy gaps," said Maranda Ward, EdD, MPH, principal investigator of the Two in One Model and assistant professor of clinical research and leadership at GW SMHS. "We are excited to hear from Joaquín Carcaño and learn about another dimension of culturally responsive communication in the primary care setting." The event is entitled "Culturally Responsive Communication, Part III: Language and Literacy Access." During the webinar, attendees will continue to learn about how culturally responsive communication can support and uplift racial, ethnic, sexual and gender minoritized patients. Additionally, the webinar will provide primary care practitioners with the tools to navigate the language and literacy needs of their patients. The webinar is scheduled for October 25, from 12 – 1 p.m. ET. Anyone can register for the event here. This is the eighth webinar in the Two in One Model training series, which utilizes a combined health and racial equity lens to provide primary care practitioners the tools to routinize HIV, PrEP/PEP, and COVID vaccine screenings for all patients and to better engage in culturally responsive communication with their minoritized patients. The series will ultimately offer nine live-streamed continuing medical education (CME) lectures as well as an asynchronous CME-bearing module-based training course and Patient Care toolkit. The program is actively engaged in formulating policy recommendations for adjusting clinical guidelines on COVID vaccine, HIV and PrEP/PEP screenings. This program has been supported by an independent educational grant from Gilead Sciences, Inc. For more information on this research-informed model, visit the Two-in-One website at: twoinone.smhs.gwu.edu. SOURCE The George Washington University School of Medicine and Health Sciences

VaccineClinical Study

06 Sep 2023

·www.prnewswire.com

George Washington University to Host Webinar on Culturally Responsive Communication

Training series highlights solutions for HIV and COVID-19 screenings in primary care WASHINGTON, Sept. 6, 2023 /PRNewswire/ -- The George Washington University School of Medicine and Health Sciences (SMHS) is hosting a free webinar on September 20 to discuss culturally responsive communication with patients. The webinar is a part of a training series for the Two in One: HIV + COVID Screening and Testing Model, a national medical education program, and will feature Adedotun Ogunbajo, PhD, of Harvard's Center for Population and Development Studies and Elder George Kerr III of the Washington D.C. Center for AIDS Research. "For the Two in One program's second webinar on the topic of culturally responsive communication, we will emphasize how clinicians can share power with patients," said Maranda Ward, EdD, MPH, principal investigator of the Two in One Model and assistant professor of clinical research and leadership at GW SMHS. "In addition to discussing ways to facilitate culturally responsive communication, we will review what sharing power in the clinician-patient interaction looks like." The event is entitled "Culturally Responsive Communication, Part II: Sharing Power with Patients," and is scheduled for September 20, from 12 p.m. – 1 p.m. ET. Anyone can register for the event here. This is the sixth webinar in the Two in One Model training series, which utilizes a combined health and racial equity lens to provide primary care practitioners the tools to routinize HIV, PrEP/PEP, and COVID vaccine screenings for all patients to better engage in culturally responsive communication with their racial, ethnic, sexual, and gender-minoritized patients. The series will ultimately offer nine live-streamed continuing medical education (CME) lectures as well as an asynchronous CME-bearing module-based training course and PCP toolkit. The program is actively engaged in formulating policy recommendations for adjusting clinical guidelines on COVID vaccine, HIV and PrEP/PEP screenings. This program has been supported by an independent educational grant from Gilead Sciences, Inc. For more information on this research-informed model, visit the Two-in-One website at: twoinone.smhs.gwu.edu. SOURCE The George Washington University School of Medicine and Health Sciences

VaccineClinical Study

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