Increase in False-Positive Fourth-Generation Human Immunodeficiency Virus Tests in Patients With Coronavirus Disease 2019.

Background: We observed an increase in the frequency of false-positive (FP) human immunodeficiency virus (HIV) test results that correlated with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) prevalence. We measured FP rates of laboratory-based fourth-generation HIV antigen/antibody test among those with polymerase chain reaction (PCR)-confirmed infection with SARS-CoV-2 compared with FP rate of those who tested SARS-CoV-2 PCR-negative.

Methods: All patients PCR tested for SARS-CoV-2 within 2 weeks of an HIV fourth-generation assay were selected.

The seroprevalence of COVID-19 in patients living with HIV in metropolitan Detroit.

Background: COVID-19, a novel respiratory illness caused by SARS-CoV-2, has become a global pandemic. As of December 2020, 4.8% of the 941 people living with HIV in our Ryan White clinic have tested polymerase chain reaction positive for SARS-CoV-2.

Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial.

Background: In a randomized, placebo-controlled, clinical trial, bamlanivimab, a SARS-CoV-2-neutralizing monoclonal antibody, given in combination with remdesivir, did not improve outcomes among hospitalized patients with COVID-19 based on an early futility assessment.

Objective: To evaluate the a priori hypothesis that bamlanivimab has greater benefit in patients without detectable levels of endogenous neutralizing antibody (nAb) at study entry than in those with antibodies, especially if viral levels are high.

Design: Randomized, placebo-controlled trial.

A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19.

Background: LY-CoV555, a neutralizing monoclonal antibody, has been associated with a decrease in viral load and the frequency of hospitalizations or emergency department visits among outpatients with coronavirus disease 2019 (Covid-19). Data are needed on the effect of this antibody in patients who are hospitalized with Covid-19.

Methods: In this platform trial of therapeutic agents, we randomly assigned hospitalized patients who had Covid-19 without end-organ failure in a 1:1 ratio to receive either LY-CoV555 or matching placebo.

Descriptive Analysis of Patients Living With HIV Affected by COVID-19.

Background: COVID-19 disease has spread globally and was declared a pandemic on March 11, 2020, by the World Health Organization. On March 10, the State of Michigan confirmed its first 2 cases of COVID-19, and the number of confirmed cases has reached 47,182 as of May 11, 2020, with 4555 deaths.

Setting: Currently, little is known if patients living with HIV (PLWH) are at a higher risk of severe COVID-19 or if their antiretrovirals are protective.

Occurrence of the S230R integrase strand inhibitor mutation in a treatment-naïve individual case report.

Rationale: Transmitted resistance to integrase strand inhibitors (INSTI) has been uncommon, but is slowly becoming more prevalent among those living with HIV. In an era with 2-drug regimens for antiretroviral therapy, transmitted resistance for INSTI is alarming.

Patient Concerns: A 28-year-old African American female was recently diagnosed with HIV during a 30-week prenatal visit.

Self-report of domestic violence and forced sex are related to sexual risk behaviors in a sample of juvenile detainees.

Background: Justice-involved youth have higher rates of sexually transmitted infections (STIs), and a higher prevalence of the associated sexual risk behaviors. Sexual risk behaviors are also associated with alcohol and drug use. Research suggests that a history of trauma is an important predictor of alcohol and drug use in youth offenders, and therefore is a likely contributor to sexual risk behavior in this population.

Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial.

Background: Since the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial.

Methods: This randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013-14 to 2017-18.

Evaluation of a Rapid Syphilis Test in an Emergency Department Setting in Detroit, Michigan.

Background: Syphilis transmission can be prevented by prompt diagnosis and treatment of primary and secondary infection. We evaluated the performance of a point-of-care rapid syphilis treponemal (RST) test in an emergency department (ED) setting.

Methods: Between June 2015 and April 2016, men aged 18 to 34 years seeking services in a Detroit ED, and with no history of syphilis, were screened for syphilis with the RST test, rapid plasma reagin (RPR) test, and Treponema pallidum particle agglutination assay (TP-PA).

Hematopoietic Stem and Progenitor Cells Are a Distinct HIV Reservoir that Contributes to Persistent Viremia in Suppressed Patients.

Long-lived reservoirs of persistent HIV are a major barrier to a cure. CD4 hematopoietic stem and progenitor cells (HSPCs) have the capacity for lifelong survival, self-renewal, and the generation of daughter cells. Recent evidence shows that they are also susceptible to HIV infection in vitro and in vivo.

CD4 is expressed on a heterogeneous subset of hematopoietic progenitors, which persistently harbor CXCR4 and CCR5-tropic HIV proviral genomes in vivo.

Latent HIV infection of long-lived cells is a barrier to viral clearance. Hematopoietic stem and progenitor cells are a heterogeneous population of cells, some of which are long-lived. CXCR4-tropic HIVs infect a broad range of HSPC subtypes, including hematopoietic stem cells, which are multi-potent and long-lived.

Early Antiretroviral Therapy at High CD4 Counts Does Not Improve Arterial Elasticity: A Substudy of the Strategic Timing of AntiRetroviral Treatment (START) Trial.

Background: Both human immunodeficiency virus (HIV) infection and antiretroviral therapy (ART) may increase cardiovascular disease (CVD) risk. Vascular function assessments can be used to study CVD pathogenesis. We compared the effect of immediate versus deferred ART initiation at CD4 counts >500 cells/mm on small arterial elasticity (SAE) and large artery elasticity (LAE).

HCV enters the twenty-first century.

Almost one-third of Americans infected with human immunodeficiency virus (HIV) and 7 million worldwide are coinfected with hepatitis C virus (HCV). The principal route of HCV spread in the US is injection drug use but there are recent reports of outbreaks of acute HCV infection among HIV-infected men who have sex with men. With increased survival as a result of highly active antiretroviral therapy, HCV-associated liver disease has become a leading cause of death in HIV-infected individuals.

Long-term effects of intermittent IL-2 in HIV infection: extended follow-up of the INSIGHT STALWART Study.

Background: The Study of Aldesleukin with and without Antiretroviral Therapy (STALWART) was designed to evaluate whether intermittent IL-2 alone or with peri-cycle ART increased CD4+ cell counts (and so delayed initiation of ART) in HIV infected individuals having ≥ 300 CD4+ cells/mm(3) compared to untreated controls. When the results of two large clinical trials, ESPRIT and SILCAAT, showed no clinical benefit from IL-2 therapy, IL-2 administration was halted in STALWART. Because IL-2 recipients in STALWART experienced a greater number of opportunistic disease (OD) or death and adverse events (AEs), participants were asked to consent to an extended follow-up phase in order to assess persistence of IL-2 effects.

Late presentation and transmitted drug resistance mutations in new HIV-1 diagnoses in Detroit.

Objective: To characterize the epidemiology and transmitted drug resistance mutation (TDRM) patterns among individuals with newly diagnosed HIV-1 infection seen at Henry Ford Hospital in Detroit from 2006 to 2008.

Methods: This was a retrospective analysis of medical records from individuals aged ≥ 18 years with a new diagnosis of HIV-1 infection. Individuals who underwent genotypic resistance testing were included in the study.

Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.

Background: The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4(+) counts compared to no therapy.

Methodology: Participants not on continuous ART with > or = 300 CD4(+) cells/mm(3) were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4(+) counts, HIV RNA, and HIV progression events were collected monthly.

Pregnancy and other factors associated with higher CD4+ T-cell counts at HIV diagnosis in Southeast Michigan, 1992-2002.

Background: Early diagnosis of HIV infection provides the opportunity for treatment to prevent progression to AIDS and for intervention to prevent further transmission. The impact of routine screening of pregnant women and other factors on the stage of HIV disease at diagnosis were evaluated.

Methods: Data were collected in 1992-2002 from the medical records of persons presenting for HIV-related care at 2 major medical centers in Detroit, Michigan.

Simultaneous runs of the Bayer VERSANT HIV-1 version 3.0 and HCV bDNA version 3.0 quantitative assays on the system 340 platform provide reliable quantitation and improved work flow.

Branched DNA (bDNA) assays to quantify human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) consist of three distinct steps, including sample processing, hybridization, and detection, and utilize the System 340 platform for plate incubation and washing. Sample processing differs: HIV-1 from 1 ml of plasma is concentrated by high-speed centrifugation, whereas HCV plasma or serum samples are used without concentration. The first step of hybridization involves viral lysis at 63 degrees C: HIV-1 is performed in a heat block, whereas HCV is performed in System 340.

Nadir CD4+ T cell count predicts response to subcutaneous recombinant interleukin-2.

Community Program for Clinical Research on AIDS 059 was a multicenter study conducted among human immunodeficiency virus (HIV)-infected individuals with CD4+ cell counts > or =300 cells/mm3 who were randomly assigned to receive antiretroviral therapy with or without intermittent subcutaneously administered recombinant interleukin-2 (rIL-2). To identify factors associated with a response to IL-2, a secondary analysis was performed that included the subset of rIL-2 recipients who were able to complete all 3 initial treatment cycles. Predictors of a change in CD4+ cell count between baseline and 1 month after the start of treatment cycle 3 were examined in a multivariate model that included sex, race, body surface area, rIL-2 dose, HIV load, and both baseline and nadir CD4+ cell count.

A randomized controlled trial evaluating the efficacy and safety of intermittent 3-, 4-, and 5-day cycles of intravenous recombinant human interleukin-2 combined with antiretroviral therapy (ART) versus ART alone in HIV-seropositive patients with 100-300 CD4+ T cells.

The effect of length of therapy on the safety and efficacy profile of continuous intravenous (CIV) interleukin-2 (IL-2) in combination with antiretroviral therapy (ART) was evaluated in 81 HIV-seropositive patients with CD4(+) T-cell counts of 100-300/mm(3). Patients were randomized to CIV IL-2 (12 mIU/day) for 3, 4, or 5 days plus ART every 8 weeks for six cycles, or to ART alone. The mean percent increase in CD4(+) T-cell counts was 24.