A5101795227- Hepatitis B Virus Studies
- Hepatitis C virus research
- Liver Disease Diagnosis and Treatment
- HIV Research and Treatment
- HIV/AIDS drug development and treatment
- HIV/AIDS Research and Interventions
- Veterinary Oncology Research
- Cervical Cancer and HPV Research
- Virus-based gene therapy research
- Viral-associated cancers and disorders
- Immune Cell Function and Interaction
- HIV-related health complications and treatments
- Oral and Maxillofacial Pathology
- Systemic Lupus Erythematosus Research
- Statistical Methods in Clinical Trials
- HIV, Drug Use, Sexual Risk
- Immune Response and Inflammation
- Congenital Heart Disease Studies
- Herpesvirus Infections and Treatments
- Mast cells and histamine
- Chronic Lymphocytic Leukemia Research
- Lymphoma Diagnosis and Treatment
- Blood groups and transfusion
- Immunodeficiency and Autoimmune Disorders
- Oral and gingival health research
Cancer Research And Biostatistics
2007-2025
Harvard University
2010-2024
Maria Fertility Hospital
2023
Jangan University
2022
Konkuk University
2011-2019
University of Cincinnati Medical Center
2017
Konkuk University Medical Center
2014
Seoul National University
2008-2010
Post Graduate Institute of Medical Education and Research
2008
Massachusetts General Hospital
2007
Women infected with human immunodeficiency virus (HIV) are disproportionately affected by papillomavirus (HPV)-related anogenital disease, particularly increased immunosuppression. AIDS Clinical Trials Group protocol A5240 was a trial of 319 HIV-infected women in the United States, Brazil, and South Africa to determine immunogenicity safety quadrivalent HPV vaccine 3 strata based on screening CD4 count: >350 (stratum A), 201-350 B), ≤200 cells/µL C). Safety serostatus types 6, 11, 16, 18...
Abstract In this international, multicenter open-label study (ACTG A5379) of HepB-CpG vaccine in people with human immunodeficiency virus (HIV) without prior hepatitis B (HBV) vaccination, all 68 participants achieved HBV seroprotective titers after the 3-dose series primary analysis. No unexpected safety issues were observed.
Background. Hepatitis C virus (HCV) entry involves scavenger receptor B1 (SRB1). In vitro, SRB1 inhibition by ITX5061 impedes HCV replication. Methods. Multicenter study to assess safety/activity of in previously untreated, noncirrhotic, genotype 1 infected adults. Design included sequential cohorts 10 subjects with (n = 8) or placebo 2) escalate duration (3 14 28 days) deescalate dose (150 75 25 mg) based on predefined criteria for safety and activity (≥4 8 RNA decline ≥1 log10 IU/mL)....
Immune activation associated with HIV-1 infection contributes to morbidity and mortality. We studied whether chloroquine, through Toll-like receptor (TLR) antagonist properties, could reduce immune thought be driven by TLR ligands, such as gut-derived bacterial elements RNAs. AIDS Clinical Trials Group A5258 was a randomized, double-blind, placebo-controlled study in 33 HIV-1-infected participants off antiretroviral therapy (ART) 37 on ART. Study each cohort were randomized 1:1 receive...
Background: International Council for Harmonisation (ICH) E9 Statistical Principles Clinical Trials was developed as a consensus guidance document to encourage worldwide harmonization of the principles statistical methodology in clinical trials. Addendum (R1) clarified and extended ICH with focus on estimands sensitivity analyses. Since release (R1), trial protocols have included estimands, but there is variation how they are presented. analysis plans (SAPs) increasingly becoming publicly...
Clinical trial designs that address multiple questions more efficiently are desirable. When we designed a hepatitis B vaccine to assess seroprotective outcomes in persons with HIV (PWH), aimed for an efficient design addressed three primary objectives two study populations. The focused on: PWH who did not respond prior HBV vaccination, and no known history of vaccination. Whereas one regimen was studied the vaccine-naïve participants, interventions were considered those nonresponse,...
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...
Efforts to increase HIV case identification through routine, voluntary testing are hindered by high refusal rates. Our objective was identify patients most likely refuse routine testing. We developed a new program at four Massachusetts urgent care centers. Patients were asked if they interested in performed analyses assess differences characteristics between those who refused and accepted it. Data available for 9129/10,354 (88%) offered from January December 2002. Of these 9129 patients, 67%...
Mild-to-moderate AIDS-associated Kaposi sarcoma (KS) often responds to antiretroviral therapy (ART) alone; the role of chemotherapy is unclear. We assessed impact immediate vs as-needed oral etoposide (ET) among human immunodeficiency virus (HIV)-infected individuals with mild-to-moderate KS initiating ART.Chemotherapy-naive, HIV type 1-infected adults ART in Africa and South America were randomized (tenofovir/emtricitabine/efavirenz) alone (chemotherapy "as-needed" arm) plus up 8 cycles ET...
Infants born to human immunodeficiency virus type 1 (HIV-1)–infected mothers were immunized at birth and ages 4, 12, 20 weeks with low-, medium-, or high-dose recombinant gp120 vaccine MF59 adjuvant (HIV-1SF-2; n=52) alone as a placebo (n=9). An accelerated schedule (birth 2, 8, weeks) was used for an additional 10 infants receiving the defined optimal dose 3 placebo. At 24 weeks, anti-gp120 ELISA titers greater vaccine-immunized than placebo-immunized on both schedules, 87% of vaccinees had...
Guidelines for limited-stage human immunodeficiency virus-associated Kaposi sarcoma (AIDS/KS) recommend antiretroviral therapy (ART) as initial treatment. However, many such individuals show worsening KS and require additional chemotherapy. Methods to identify patients are lacking.
Children of mothers infected with human immunodeficiency virus type 1 (HIV-1) were immunized at birth and 1, 3, 5 months 3 doses recombinant gp120 vaccines prepared from SF-2 or MN strains HIV-1. A total 126 children not infected; 21 received adjuvant only. Vaccine recipients developed lymphoproliferative responses on ⩾2 occasions, responding more often to homologous HIV-1 antigens than did (56% vs. 14%; P < .001). Responses appreciated after 2 immunizations maintained for >84 weeks the last...
Objectives The extent to which highly active antiretroviral therapy ( HAART ) affects human papillomavirus HPV acquisition and clearance in HIV ‐infected women is not well understood. We sought describe high‐risk detection rates over time since initiation, based on time‐varying viral load VL CD4 T‐cell count, using novel statistical methods. Methods conducted a retrospective analysis of data from the completed AIDS C linical T rials G roup ACTG A 5029 study multi‐state M arkov models. Two...
Introduction: With advances in hepatitis B virus (HBV) therapies, there is a need to identify serum biomarkers that assess the HBV covalently closed circular DNA (cccDNA) reservoir and predict functional cure HIV/HBV co-infection. Methods: In this retrospective study, combining samples from co-infected participants enrolled two ACTG interventional trials, proportions achieving HBsAg less than 0.05 log 10 IU/ml RNA 1.65 U/ml or not detected (LLoQ/NEG) response DUAL [tenofovir...
People living with HIV have increased Human Papillomavirus (HPV) related lesions and malignancies. We describe HPV DNA recovered from the cervix anal canal, explore effect of vaccination on detection, examine durability vaccine titers in women HIV-1 who were vaccinated quadrivalent vaccine. AIDS Clinical Trials Group A5240 was a prospective study (qHPV) 315 infected three CD4 strata (A: >350, B; 201-350, C: ≤200 cells/mm3). Vaccine administered at entry, week 8 24. Cervical specimens...
Objectives: To characterize HIV/hepatitis B virus (HBV) coinfection in the AIDS Clinical Trials Group Longitudinal Linked Randomized cohort and compare long-term HBV outcomes between regimens with 1 (MONO) or 2 (DUAL) anti-HBV agents. Design: A retrospective study of coinfected subjects who received containing agent(s). Methods: Stored samples at baseline weeks 16, 32, 48, 144, 240 were tested for DNA, e antigen (HBeAg), antibody (HBeAb), hepatitis D (HDV) antibody. Resistance genotype DNA...
Early progression of AIDS-associated Kaposi sarcoma (KS-PD) and immune reconstitution inflammatory syndrome (KS-IRIS) sometimes occur after the initiation antiretroviral therapy (ART).
The clinical, immunologic, and virologic effects the pharmacokinetics of human immunodeficiency virus (HIV) hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2–11 years. All had moderately advanced disease with an immune complex-dissociated (ICD) p24 antigen >70 pg/mL on stable antiviral therapy. Three groups 10 received 6 monthly infusions 200, 400, or 800 mg/kg HIVIG, serial immunologic assays performed. HIVIG doses as high safe well tolerated. half-life...
Study objectives were to evaluate the safety and immunogenicity of three HIV recombinant glycoproteins in HIV-infected infants children between 1 month 18 years age with asymptomatic (P-1) infection. Using Chiron rgp 120 (SF-2) 15 or 50 microg; MicroGeneSys 160 (IIIB) 40 320 Genentech rgp120 (MN) 75 300 adjuvant control (Alum MF-59), randomized a double-blind, placebo-controlled, dose-escalating study vaccine administered intramuscularly at entry 1, 2, 3, 4, 6 months later. No adverse events...