Phase I Dose Volume Escalation of Rectally Administered PC-1005 to Assess Safety, Pharmacokinetics, and Antiviral Pharmacodynamics as a Multipurpose Prevention Technology (MTN-037).

Background: On demand, topical PrEP is desired by those preferring episodic, nonsystemic PrEP. PC-1005 gel (MIV-150, zinc, and carrageenan) exhibits in vitro antiviral HIV-1, human papillomavirus (HPV), and herpes simplex virus type 2 (HSV-2) activity, attractive for a multipurpose prevention technology candidate. We evaluated the safety, pharmacokinetics, and antiviral effect of rectally applied PC-1005.

Reassessing heart failure therapy in Thailand: Patient insights and treatment outcomes from the Thai heart failure registry.

Background: This research analyzed the demographics, management, and outcomes of patients with heart failure (HF) in Thailand.

Methods: The Thai Heart Failure Registry prospectively enrolled patients diagnosed with HF from 36 hospitals in Thailand. Follow-up data were recorded at 6, 12, 18, and 24 months.

A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention.

Background: On-demand topical products could be an important tool for human immunodeficiency virus (HIV) prevention. We evaluated the safety, pharmacokinetics, and ex vivo pharmacodynamics of a tenofovir alafenamide/elvitegravir (TAF/EVG, 20 mg/16 mg) insert administered rectally.

Methods: MTN-039 was a phase 1, open-label, single-arm, 2-dose study.

MTN-033: a Phase 1 Study Comparing Applicator versus "as Lubricant" Delivery of Rectal Dapivirine Gel.

Data to inform behaviorally congruent delivery of rectal microbicides as lubricants are scant. Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor which has been demonstrated to be well-tolerated and efficacious in multiple clinical trials when used in a vaginal ring formulation. DPV gel administered rectally with an applicator was found to be well-tolerated in a phase 1 clinical trial.

Patient Characteristics, Procedural Details, and Outcomes of Contemporary Percutaneous Coronary Intervention in Real-World Practice: Insights from Nationwide Thai PCI Registry.

Background: Percutaneous coronary intervention (PCI) practice and outcomes vary substantially in different parts of the world. The contemporary data of PCI in Asia are limited and only available from developed Asian countries.

Objectives: To explore the pattern of practice and results of PCI procedures in Thailand as well as a temporal change of PCI practice over time compared with the registry from other countries.

Acceptability of a Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-033 Study).

We triangulated quantitative and qualitative assessments to evaluate participants' acceptability of 0.05% dapivirine rectal microbicide (RM) gel administered via two separate modalities (a rectal applicator and an artificial phallus for use as a coital simulation device) as part of a Phase I trial (N = 14) among men who have sex with men (MSM) randomized using a 1:1 ratio. Overall, participants reported favorable acceptability of the gel (n = 11; 78.

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

Dapivirine (DPV), formulated as vaginal ring, demonstrated HIV risk reduction. MTN-026 explored DPV, formulated as rectal gel, for safety, pharmacokinetics (PK), and acceptability. HIV-uninfected men and women aged 18-45 years were enrolled at United States and Thailand sites and randomized 2:1 to receive DPV 0.

Optimal INR level in elderly and non-elderly patients with atrial fibrillation receiving warfarin: a report from the COOL-AF nationwide registry in Thailand.

Background: Asian population are at increased risk of bleeding during the warfarin treatment, so the recommended optimal international normalized ratio (INR) level may be lower in Asians than in Westerners. The aim of this prospective multicenter study was to determine the optimal INR level in Thai patients with non-valvular atrial fibrillation (NVAF).

Methods: Patients with NVAF who were on warfarin for stroke prevention were recruited from 27 hospitals in the nationwide COOL-AF registry in Thailand.

Adherence to Anticoagulant Guideline for Atrial Fibrillation Improves Outcomes in Asian Population: The COOL-AF Registry.

Background and Purpose- Guideline adherent oral anticoagulant (OAC) management of patients with nonvalvular atrial fibrillation has been associated with improved outcomes, but limited data are available from Asia. We aimed to investigate outcomes in patients who received guideline compliant management compared with those who were OAC undertreated or overtreated, in a large nationwide multicenter cohort of patients with nonvalvular atrial fibrillation in Thailand. Methods- Patients with nonvalvular atrial fibrillation were prospectively enrolled from 27 hospitals-all of which are data contributors to the COOL-AF Registry (Cohort of Antithrombotic Use and Optimal INR Level in Patients With Non-Valvular Atrial Fibrillation in Thailand).

History of major bleeding predicts risk of clinical outcome of patients with atrial fibrillation: results from the COOL-AF registry.

Objective: To compare clinical outcomes between patients with and without history of major bleeding according to types of antithrombotic medications in patients with non-valvular atrial fibrillation (NVAF).

Methods: We conducted a multicenter registry of patients with NVAF during 2014 to 2017 in Thailand. The following data were collected: demographic data, type of NVAF, medical illness, components of CHADS-VASc and HAS-BLED scores, history of bleeding and severity, investigations, and antithrombotic medications.

Ten-year survival and factors associated with increased mortality in patients admitted for acute decompensated heart failure in Thailand.

Introduction: Data on the long-term outcomes of Asian patients admitted for acute decompensated heart failure is scarce. The objectives of this study were to determine short-term, intermediate-term and long-term survival among patients admitted for acute decompensated heart failure in Thailand, and to identify factors independently associated with increased mortality.

Methods: Patients who were admitted with a primary diagnosis of heart failure were enrolled in the Thai Acute Decompensated Heart Failure Registry (ADHERE) from 18 hospitals located across Thailand during 2006.

Prevalence and determinants of anal human papillomavirus infection in men who have sex with men and transgender women.

Human papillomavirus (HPV) prevalence varies by population. This study investigated anal HPV type detection risk by country in a population of men who have sex with men (MSM) and transgender women (TW) at risk of HIV. Sexually active HIV-1-uninfected MSM and TW were enrolled at eight sites: four in the United States (US), two in Thailand, one in Peru, and one in South Africa.

Risk profiles and pattern of antithrombotic use in patients with non-valvular atrial fibrillation in Thailand: a multicenter study.

Background: Anticoagulation therapy is a standard treatment for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) that have risk factors for stroke. However, anticoagulant increases the risk of bleeding, especially in Asians. We aimed to investigate the risk profiles and pattern of antithrombotic use in patients with NVAF in Thailand, and to study the reasons for not using warfarin in this patient population.

Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.

Background: Evidence is lacking regarding whether vaginal pre-exposure prophylaxis with topical tenofovir (TFV) reduces the risk of rectal HIV acquisition.

Setting: Bronx, NY.

Methods: MTN-014 was a phase 1, cross-over, randomized sequence trial comparing the cross-compartment pharmacokinetics and pharmacodynamics of daily TFV reduced-glycerin 1% gel after 14 days each of rectal and vaginal application, with directly observed dosing and a 6-week washout period between phases.

Management of atherosclerosis risk factors for patients at high cardiovascular risk in real-world practice: a multicentre study.

Introduction: Atherosclerotic cardiovascular disease is a global health burden. However, there are heterogeneities among countries or regions in the risk factors and clinical manifestations of atherosclerotic diseases as well as management patterns.

Methods: We collected data from 25 centres in Thailand.

Demographics and Outcomes of Percutaneous Coronary Intervention in Thailand: Data from Thai Percutaneous Coronary Intervention Registry.

Background: Percutaneous coronary intervention (PCI) has been and continues to be standard treatment in patients with coronary artery disease. The data for demographic and outcomes in Thailand are limited.

Objective: To study data and characteristics relating to patients, the procedure, and outcomes of percutaneous coronary intervention in the Thai population.

MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.

Background: Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed.

Methods: MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF).

A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy.

Introduction: Vaginal tenofovir (TFV) 1% gel may reduce incident HIV-1 and herpes simplex virus 2 infection. Pregnancy may increase risk of HIV acquisition, and incident HIV in pregnancy potentiates perinatal HIV transmission. Our objective was to investigate the safety and pharmacokinetics of seven days of TFV 1% vaginal gel in term and near-term pregnancy.

Management and risk factor control of coronary artery disease in elderly versus nonelderly: a multicenter registry.

Background: Coronary artery disease (CAD) is a leading cause of death in elderly because aging is the important non-modifiable risk factors of atherosclerosis and also a predictor of poor outcomes. Underuse of guideline directed therapy may contribute to suboptimal risk factor control and worse outcomes in the elderly. We aimed to explore the management of CAD, risk factors control as well as goal attainment in elderly compared to nonelderly CAD patients.

Predictors of in-hospital mortality in acute decompensated heart failure (Thai ADHERE).

Background: Heart failure had emerged as a major public health problem and became the leading cause of hospitalization. The Acute Decompensated Heart Failure National Registry (ADHERE) of US patients hospitalized with a primary diagnosis of acute decompensated heart Failure (ADHF) had been reported worldwide for the risk stratification and predicting In-hospital mortality.

Objective: Identify clinical risk factors or treatment procedures that could predict In-hospital mortality in Thai patients with ADHF.

Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity.

Because lubricants may decrease trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. Therefore, safety and anti-HIV-1 activity of over-the-counter (OTC) aqueous- (n = 10), lipid- (n = 2), and silicone-based (n = 2) products were tested. The rheological properties of the lipid-based lubricants precluded testing with the exception of explant safety testing.

Thai Registry in Acute Coronary Syndrome (TRACS)--an extension of Thai Acute Coronary Syndrome registry (TACS) group: lower in-hospital but still high mortality at one-year.

Background: The Thai Registry of Acute Coronary Syndrome (TRACS) registry was conducted five years after the first Thai Acute Coronary Syndrome (ACS) registry.

Objective: To describe demographics, management practices, and in-hospital outcomes of current Thai ACS patients and to seek for any significant changes in this registry from the earlier first Thai ACS registry.

Material And Method: The TRACS is a multi-centers, prospective, nation-wide registration with 39 participating medical centers.

Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy.

Unlabelled: Tenofovir (TFV) 1% vaginal gel has been found to decrease sexual transmission of human immunodeficiency virus. To initiate investigations during pregnancy, 16 healthy pregnant women scheduled for cesarean delivery received a single application of TFV gel preoperatively. Maternal serum drug concentrations were determined and fetal cord blood, amniotic fluid, placental tissue, and endometrial tissue specimens were collected.