- HIV Research and Treatment
- HIV/AIDS drug development and treatment
- HIV/AIDS Research and Interventions
- Diabetes and associated disorders
- Diabetes Management and Research
- Immune Cell Function and Interaction
- Pneumocystis jirovecii pneumonia detection and treatment
- Pancreatic function and diabetes
- T-cell and B-cell Immunology
- Hepatitis B Virus Studies
- Systemic Lupus Erythematosus Research
- Immunotherapy and Immune Responses
- Immunodeficiency and Autoimmune Disorders
- T-cell and Retrovirus Studies
- Blood groups and transfusion
- Salivary Gland Disorders and Functions
- HIV-related health complications and treatments
- Lymphoma Diagnosis and Treatment
- Salivary Gland Tumors Diagnosis and Treatment
- SARS-CoV-2 and COVID-19 Research
- Herpesvirus Infections and Treatments
- Epilepsy research and treatment
- Health and Lifestyle Studies
- Pneumonia and Respiratory Infections
- Tuberculosis Research and Epidemiology
National Institute of Allergy and Infectious Diseases
2011-2025
National Institutes of Health
2004-2025
Duke University
1998-2021
University of Massachusetts Chan Medical School
2009
University of Maryland, Baltimore
2007
National Institute of Child Health
2007
University of Colorado Denver
2006
GTx (United States)
2006
Office of AIDS Research
2001-2005
University of Tennessee Health Science Center
2004
Trials of immune therapies in new-onset type 1 diabetes (T1D) have shown success, but not all subjects respond, and the duration response is limited. Our aim was to determine whether two courses teplizumab, an Fc receptor–nonbinding anti-CD3 monoclonal antibody, reduces decline C-peptide levels patients with T1D 2 years after disease onset. We also set out identify characteristics responders. treated 52 teplizumab for weeks at diagnosis year open-label, randomized, controlled trial. In...
BACKGROUND. Type 1 diabetes (T1D) results from destruction of pancreatic β cells by autoreactive effector T cells. We hypothesized that the immunomodulatory drug alefacept would result in targeted quantitative and qualitative changes prolonged preservation endogenous insulin secretion remaining patients with newly diagnosed T1D.
Consistent long-term viral suppression has been difficult to achieve in children with human immunodeficiency virus type 1 (HIV-1) infection. We tested the safety and antiviral efficacy of a novel combination consisting efavirenz, nelfinavir, one or more nucleoside reverse-transcriptase inhibitors 57 previously treated only inhibitors.
Adoptive Treg cell therapy has great potential to treat autoimmune disease. Currently, very little is known about how these cells impact inflamed tissues. This study was undertaken elucidate autologous influences tissue inflammation in human disease.We describe a systemic lupus erythematosus (SLE) patient with active skin disease who received adoptive therapy. We comprehensively quantified and immune activation peripheral blood skin, data obtained at multiple time points...
To study the safety and clinical efficacy of rituximab therapy for primary Sjögren's syndrome, as well to investigate its mechanisms.Patients with syndrome were enrolled in an open-label trial, given (1 gm) infusions on days 1 15, monitored through week 52. The end point was safety, secondary points evaluating biologic efficacy. Blood obtained enumeration lymphocyte subsets, measurement serum autoantibody BAFF levels, analysis gene expression.Twelve female patients administered rituximab....
Objective: To determine the ability of live attenuated canarypox virus expressing HIV antigens to induce CD8+ cytotoxic T-cell responses and prime for neutralizing antibody boosting with purified recombinant gp120 subunit vaccine. Design: A prospective, double-blind, randomized, immunogenicity safety study was conducted in healthy adults at low risk acquiring infection who were seronegative HIV. Methods: T-cells directed against Env or Gag target cells measured after canarypox-HIV-1 vaccine...
Live attenuated viral vectors that express human immunodeficiency virus (HIV) antigens are being developed as potential vaccines to prevent HIV infection. The first phase 2 trial with a canarypox vector (vCP205, which expresses gp120, p55, and protease) was conducted in 435 volunteers without gp120 boosting, expand the safety database compare immunogenicity of who were at higher risk lower for Neutralizing antibodies MN strain stimulated 94% given vCP205 plus 56% alone. CD8+ cytotoxic T...
To compare the safety of nelfinavir and nevirapine-based antiretroviral treatment in HIV-1-infected pregnant women.In Pediatric AIDS Clinical Trials Group Protocol 1022, 38 antiretroviral-naive women at 10-30 weeks' gestation were randomized to or nevirapine with zidovudine plus lamivudine. The study was suspended because greater than expected toxicity changes prescribing information. incidence treatment-limiting hepatic cutaneous compared between groups for all subjects subset CD4 cell...
Objective To evaluate the clinical efficacy and safety of baminercept, a lymphotoxin β receptor IgG fusion protein ( LT βR‐Ig), for treatment primary Sjögren's syndrome SS ), to explore possible mechanisms action this treatment. Methods In multicenter trial, 52 patients with were randomized in 2:1 ratio receive subcutaneous injections 100 mg baminercept every week 24 weeks or matching placebo. The end point was change between screening stimulated whole salivary flow SWSF ) rate. Secondary...
Background. Adolescents represent the fastest growing demographic group of new human immunodeficiency virus (HIV) infections in United States. At present, there is little information available about their response to therapy. Methods. We studied 120 adolescents infected via high-risk behaviors who began receiving highly active antiretroviral therapy (HAART), determine virologic and immunologic Results. Subjects were enrolled at 28 sites Pediatric Acquired Immunodeficiency Syndrome Clinical...
Five New Jersey populations of Amphicarpum purshii (an annual panicoid grass) were investigated as to total allocation biomass reproduction and its distribution between aerial chasmogamous subterranean cleistogamous inflorescences. Germination both types seed was documented, for the first time, in not only field but under three laboratory temperature regimes. Overall, approximately 29 % shoot allocated reproduction. On a population basis, inflorescences accounted 37–100 reproductive biomass,...
The mechanisms whereby immune therapies affect progression of type 1 diabetes (T1D) are not well understood. Teplizumab, an FcR nonbinding anti‐CD3 mAb, has shown efficacy in multiple randomized clinical trials. We previously reported increase the frequency circulating CD8 + central memory (CD8CM) T cells responders, but generalizability this finding and molecular effects teplizumab on these have been evaluated. analyzed data from two studies patients with new‐ recent‐onset T1D. At...
Abstract Objective To address heterogeneity complicating primary SS (pSS) clinical trials, research and care by characterizing clustering patients their molecular phenotypes. Methods pSS met American–European Consensus Group classification criteria had at least one systemic manifestation stimulated salivary flow of ⩾0.1 ml/min. Correlated transcriptional modules were derived from gene expression microarray data blood (n = 47 with appropriate samples). Patients clustered based on this...
Background. IL-6 receptor (IL-6R) signaling drives development of T cell populations important to type 1 diabetes pathogenesis. We evaluated whether blockade IL-6R with monoclonal antibody tocilizumab would slow loss residual β function in newly diagnosed patients.
One hundred eighty-one antiretroviral-experienced, protease inhibitor-naive, clinically stable HIV-infected children between 4 months and 17 years of age were randomly assigned to receive one four combination regimens evaluate the change in plasma HIV RNA, safety, tolerance when changing antiretroviral therapy a inhibitor-containing regimen. All contained stavudine; addition received nevirapine plus ritonavir, lamivudine nelfinavir, or nelfinavir. Twelve additional chose stavudine with...
The relative potency and tolerability of multidrug regimens used to treat infants children infected with human immunodeficiency virus type 1 (HIV-1) are largely unknown. In Pediatric AIDS Clinical Trials Group (PACTG) Protocol 377, 181 were assigned receive stavudine (d4T) plus nevirapine (NVP) ritonavir (RTV); d4T lamivudine (3TC) nelfinavir (NFV); NVP NFV; or 3TC, NVP, NFV. Eleven additional received NFV given twice daily. All subjects had not previously protease inhibitors nonnucleoside...
This is a summary report of clinical and regulatory issues discussed at the 2018 NINDS workshop, entitled "Accelerating Therapies for Antiepileptogenesis Disease Modification." The intent workshop was to optimize accelerate development therapies antiepileptogenesis (AEG) disease modification in epilepsies. working group nomenclature antiepileptogenic therapies, subdividing them into "antiepileptogenic therapies" "disease modifying therapies," both which are urgently needed. We use example...
Autoimmune disease patients on immunosuppressants exhibit reduced humoral responses to primary COVID-19 vaccination. Booster vaccine and the effects of holding immunosuppression around vaccination are less studied. We evaluated efficacy safety additional in mycophenolate mofetil/mycophenolic acid (MMF/MPA)-, methotrexate (MTX)-, B cell-depleting therapy (BCDT)-treated autoimmune patients, including impact withholding MMF/MPA MTX. In this open-label, multicenter, randomized trial, 22...
The use of recombinant CD4-IgG2 in pediatrie human immunodeficiency virus type 1 (HIV-1) infection was evaluated by single and multidose intravenous infusions 18 children a phase 1/2 study. study drug well tolerated, dose proportionality observed terms area under time-concentration curve peak serum concentration. Acute decreases >0.7 log10 copies/mL HIV-1 RNA concentration were seen 4 the 6 treated with weekly 10 mg/kg doses. At 14 days after treatment, 3 had sustained reductions RNA; other...
To determine the safety of 2 candidate vaccines against human immunodeficiency virus type 1 (HIV-1), a randomized, placebo-controlled, multicenter trial compared low, medium, and high doses or an adjuvant among infants born to HIV-infected women. No local systemic reactions grade greater were reported 48 h after subjects underwent immunization. Grade 3 4 chemistry toxicities occurred in 5 (3%) hematologic 17 (11%) 154 vaccinated (not significantly different from 29 recipients). CD4(+) cell...