Sexual Partner Characteristics, Relationship Type, and HIV Risk Among a Community Venue-based Sample of Urban Adolescent and Young Adult Men Who Have Sex with Men.

Few studies have examined sexual partnerships and HIV risk in diverse samples of African American/black and Hispanic/Latino adolescent and young adult men who have sex with men (YMSM), a group that have a high burden of HIV in the U.S. A community-venue recruitment approach was used, which identified significant differences in HIV risk by sexual partner type among 1215 YMSM. Those with casual partners had a higher number of sexual partners, had more STIs, and were more likely to engage in transactional sex, to use alcohol, marijuana, or other substances compared with those with main partners only. Among those with female sexual partners, many used condoms "every time" when engaging in vaginal sex with casual partners, but a sizeable proportion "never/rarely" used condoms with their main partners. Our findings demonstrate a need for tailored HIV prevention education and counseling with necessary skills regarding consistent and correct condom use with all sexual partnerships.

Provision of Specific Dental Procedures By General Dentists in the National Dental Practice-Based Research Network: Questionnaire Findings.

BACKGROUND: Objectives were to: (1) determine whether and how often general dentists (GDs) provide specific dental procedures; and (2) test the hypothesis that provision is associated with key dentist, practice, and patient characteristics. METHODS: GDs (n = 2,367) in the United States National Dental Practice-Based Research Network completed an Enrollment Questionnaire that included: (1) dentist; (2) practice; and (3) patient characteristics, and how commonly they provide each of 10 dental procedures. We determined how commonly procedures were provided and tested the hypothesis that provision was substantively related to the 3 sets of characteristics. RESULTS: Two procedure categories were classified as "uncommon" (orthodontics, periodontal surgery), 3 were "common" (molar endodontics; implants; non-surgical periodontics), and 5 were "very common" (restorative; esthetic procedures; extractions; removable prosthetics; non-molar endodontics). Dentist, practice, and patient characteristics were substantively related to procedure provision; several characteristics seemed to have pervasive effects, such as dentist gender, training after dental school, full-time/part- time status, private practice vs. institutional practice, presence of a specialist in the same practice, and insurance status of patients. CONCLUSIONS: As a group, GDs provide a comprehensive range of procedures. However, provision by individual dentists is substantively related to certain dentist, practice, and patient characteristics. A large number and broad range of factors seem to influence which procedures GDs provide. This may have implications for how GDs respond to the ever-changing landscape of dental care utilization, patient population demography, scope of practice, delivery models and GDs' evolving role in primary care.

Cross-sectional survey comparing HIV risk behaviours of adolescent and young adult men who have sex with men only and men who have sex with men and women in the U.S. and Puerto Rico.

OBJECTIVE: To examine the HIV risk behaviours of men who have sex with men only (MSMO) and men who have sex with men and women (MSMW), aged 12-24 years, in five US cities and in San Juan, Puerto Rico. METHODS: Data were collected through four annual cross-sectional anonymous surveys at community venues and included questions about sexual partnerships, sexual practices including condom use and substance use. Demographic and risk profiles were summarised for both groups. RESULTS: A total of 1198 men were included in this analysis, including 565 MSMO and 633 MSMW. There were statistically significant differences between the two groups for many risk factors examined in multivariable models. MSMW were more likely to identify as bisexual, be in a long-term relationship, have a history of homelessness, have ever used marijuana, have ever been tested for HIV and to have been tested for HIV within the past 6 months. MSMW may be more likely to ever exchange sex for money and ever have a sexually transmitted infection than MSMO. CONCLUSIONS: MSMW were more likely to report several markers of socioeconomic vulnerability or behaviours associated with increased risk for HIV than MSMO. MSMW contribute to HIV prevalence in the USA, and better understanding of the risk profile of this group is essential to understand heterosexual HIV transmission. MSMW, particularly those who identify as bisexual or questioning, may feel uncomfortable participating in programmes that are designed for gay-identified men. Therefore, prevention strategies need to target distinct subgroups that compose the population of MSM.

Provision of specific dental procedures by general dentists in the National Dental Practice-Based Research Network: questionnaire findings.

BACKGROUND: Objectives were to: (1) determine whether and how often general dentists (GDs) provide specific dental procedures; and (2) test the hypothesis that provision is associated with key dentist, practice, and patient characteristics. METHODS: GDs (n = 2,367) in the United States National Dental Practice-Based Research Network completed an Enrollment Questionnaire that included: (1) dentist; (2) practice; and (3) patient characteristics, and how commonly they provide each of 10 dental procedures. We determined how commonly procedures were provided and tested the hypothesis that provision was substantively related to the three sets of characteristics. RESULTS: Two procedure categories were classified as "uncommon" (orthodontics, periodontal surgery), three were "common" (molar endodontics; implants; non-surgical periodontics), and five were "very common" (restorative; esthetic procedures; extractions; removable prosthetics; non-molar endodontics). Dentist, practice, and patient characteristics were substantively related to procedure provision; several characteristics seemed to have pervasive effects, such as dentist gender, training after dental school, full-time/part-time status, private practice vs. institutional practice, presence of a specialist in the same practice, and insurance status of patients. CONCLUSIONS: As a group, GDs provide a comprehensive range of procedures. However, provision by individual dentists is substantively related to certain dentist, practice, and patient characteristics. A large number and broad range of factors seem to influence which procedures GDs provide. This may have implications for how GDs respond to the ever-changing landscape of dental care utilization, patient population demography, scope of practice, delivery models and GDs' evolving role in primary care.

Characteristics of HIV infected adolescents in Latin America: results from the NISDI pediatric study.

OBJECTIVE: HIV-infected adolescents are a heterogeneous population; source of infection, immunodeficiency severity and antiretroviral (ARV) experience vary. Here, we describe youth followed in an observational study at Latin American sites of the NICHD International Site Development Initiative (NISDI). METHODS: The NISDI pediatric protocol is an ongoing prospective cohort study that collects demographic, clinical, immunologic, virologic and medication data. Youth were enrolled at 15 sites in Brazil, Argentina and Mexico between 2002 and 2006. HIV-infected subjects aged 12-21 years at the time of enrollment were analyzed. RESULTS: Data from 120 HIV-infected youth were analyzed. Sixty-nine (58%) had acquired HIV through vertical transmission (VT); 51(42%) via horizontal transmission (HT). Twenty-eight percent of the VT group were not diagnosed until they were ≥10 years of age. Ninety-one percent of the VT group and 46% of the HT were receiving ARV at enrollment. Modes of HT included sexual (ST), blood product transfusion (BPT) and unknown (U). Severe immunodeficiency was frequent (21%) in the ST group. Low BMI was frequent in the VT and BPT sub-groups. Utilization of HAART increased over the course of the study, but viral suppression was present in only 38% of the VT group and 37% of the HT group at study end. CONCLUSIONS: This cohort of HIV-infected adolescents in Latin America displayed a diverse epidemiologic pattern. Care providers must be prepared to address the diverse needs and challenges of this population. The levels of virologic suppression achieved were inadequate. Further research into appropriate interventions for this population is urgently needed.

Impact of the 2004 Food and Drug Administration pediatric suicidality warning on antidepressant and psychotherapy treatment for new-onset depression.

OBJECTIVE: To assess the national impact of the March 2004 Food and Drug Administration (FDA) antidepressant suicidality warning on the outpatient treatment of new-onset depression in youth. METHOD: A repeated measures, longitudinal design in a cohort of youth diagnosed with new-onset depression was used to assess pre- and post-FDA warning effects. US commercial insurance enrollees in the i3 INNOVUS database from January 2003 through December 2006 were examined. The study population included youth 2- to 17-years old with a new-onset depression diagnosis from July 2003 through June 2006 (N = 40,309). The main independent variables were the warning period (post- vs. pre-FDA warning) and age group (children vs. adolescents). The main outcome measures were youth with antidepressant dispensings and psychotherapy visits measured in 30-day intervals across 36 months following a new-onset diagnosis of any depressive disorder (N = 40,309) and specifically major depressive disorder (MDD) (N = 11,532). RESULTS: Compared to youth with a new-onset diagnosis of depression in the pre-FDA warning period, youth with new-onset diagnosis of depression during the postwarning period had (1) A significantly lower likelihood of antidepressant use: (odds ratio [OR] = 0.85 [0.81-0.89]); When youth with the diagnosis of depression were separated into those with MDD and those with less severe depression diagnoses, only the latter had a significant postwarning antidepressant decline. (2) A significant increase in the odds of a psychotherapy visit (children, OR = 1.31 [1.23-1.40]; adolescents OR = 1.19 [1.15-1.24]). CONCLUSIONS: The FDA suicidality warning was associated with an overall decrease in antidepressant treatment for youth with a clinician-reported diagnosis of depression, but not for those with MDD. Also, following the warning, psychotherapy without medication increased.

Missed opportunities for prevention of mother-to-child transmission of human immunodeficiency virus type 1 in Latin America and the Caribbean: the NISDI perinatal study.

Cases of mother-to-child transmission (MTCT) of human immunodeficiency virus type 1 (HIV-1) in a prospective cohort study in Latin America and the Caribbean were analyzed. Eight of 820 eligible infants became infected [transmission rate, 0.98% (95% CI = 0.45-1.96%)]. Five cases (62%) represented missed opportunities for prevention of MTCT of HIV-1, suggesting the need for ongoing training and education of clinicians regarding prevention of MTCT of HIV-1.

Psychotherapeutic medication prevalence in Medicaid-insured preschoolers.

OBJECTIVE: To update knowledge of the prevalence of the use of psychotherapeutic medications in preschoolers with Medicaid insurance as requested by the Best Pharmaceuticals for Children Act of 2002 (BPCA). METHOD: Prescription, enrollment, and outpatient visit data from 7 state Medicaid programs were used to identify 274,518 youths continuously enrolled in 2001 and aged 2 to 4 on January 1, 2001. Annual prevalence of use was defined as one or more dispensed prescriptions for a psychotherapeutic medication and adjusted for anticonvulsant and anxiolytic/sedative/hypnotic use according to ICD-9 diagnostic groupings. Prevalence ratios adjusted for age, race/ethnicity, and gender were estimated. RESULTS: 2.30% (CI = 2.24, 2.36) of preschoolers received one or more dispensings for a psychotherapeutic medication in 2001, approximately doubling the usage of comparable youth from 2 other state Medicaid programs studied in 1995. Boys were 2.4 times more likely than girls to receive psychotherapeutic medication. Whites were 4 times more likely than Hispanics and twice as likely as Blacks to receive medication for psychiatric or behavioral conditions. Since the mid-1990s, usage increased, especially for atypical antipsychotics and antidepressants. The prominent use of anticonvulsants (78.8%) and anxiolytic/sedative/hypnotic drugs (91.4%) in those with no psychiatric diagnosis, but with other medical diagnoses, shows that much use therein reflects treatment for seizures, rather than mood stabilization, and for minor medical conditions, rather than psychiatric disorders. CONCLUSION: Preschool psychotherapeutic medication use increased across ages 2 to 4 for stimulants, antipsychotics, and antidepressants, reflecting use for psychiatric/behavioral disorders. However, the use of anxiolytic/sedative/hypnotics and anticonvulsants was more stable across these years, suggesting medical usage. Additional research to assess the benefits and risks of psychotherapeutic drugs is needed, particularly when such usage is off-label for both psychiatric and nonpsychiatric conditions.

Temporal trends and drug exposures in pulmonary hypertension: an American experience.

BACKGROUND: Reports have linked anorexigen intake to an increased risk of pulmonary arterial hypertension (PAH). With the rise in anorexigen use in the latter half of the last decade, we established a surveillance network within the United States to monitor temporal trends in the number of reported cases of PAH. We also studied whether use of anorexigens and other drugs differed among patients with pulmonary hypertension of different etiologies. METHODS: Newly diagnosed subjects (N = 1335) at 13 tertiary pulmonary hypertension centers were enrolled between January 1998 and June 2001. Patient-reported medication use was obtained by a telephone interview. Patients were classified as to the type of pulmonary hypertension. Poisson regression models were fitted to monthly case counts, and logistic regression methods were used to assess the association between type of pulmonary hypertension and medication use. RESULTS: The average monthly number of reported cases of PAH and other categories of pulmonary hypertension did not change over the study period. Fenfluramine or dexfenfluramine use during the 5 years before the time of the interview was preferentially associated with PAH. Fenfluramine/dexfenfluramine use was particularly common in cases referred but found not to have pulmonary hypertension. CONCLUSIONS: No epidemic of anorexigen-related PAH was evident during the study period. As persons who had taken fenfluramine or dexfenfluramine were particularly likely to be referred for evaluation of pulmonary hypertension, it is unlikely that the failure to detect an anorexigen-induced rise in primary pulmonary hypertension was because of underascertainment. The association between fenfluramine derivatives and PAH is consistent with the risk elevations previously reported.

Gestational thyrotoxicosis, antithyroid drug use and neonatal outcomes within an integrated healthcare delivery system.

BACKGROUND: Increasing attention has focused on the prevalence and outcomes of hyperthyroidism in pregnancy, given concerns for hepatotoxicity and embryopathy associated with antithyroid drugs (ATDs). METHODS: In an integrated health care delivery system, we examined the prevalence of thyrotoxicosis and gestational ATD use (propylthiouracil [PTU] or methimazole [MMI]) in women with delivered pregnancies from 1996 to 2010. Birth outcomes were compared among all infants and those born to mothers with diagnosed thyrotoxicosis or ATD therapy during gestation, with examination of ATD-associated hepatotoxicity and congenital malformations in the latter subgroups. RESULTS: Among 453,586 mother-infant pairs (maternal age 29.7±6.0 years, 57.1% nonwhite), 3.77 per 1000 women had diagnosed thyrotoxicosis and 1.29 per 1000 had gestational ATD exposure (86.5% PTU, 5.1% MMI, 8.4% both). Maternal PTU-associated hepatotoxicity occurred with a frequency of 1.80 per 1000 pregnancies. Infants of mothers with diagnosed thyrotoxicosis (odds ratio [OR] 1.28, 95% confidence interval [CI 1.05-1.55]) or gestational ATD use (OR 1.31 [1.00-1.72]) had an increased risk of preterm birth compared to those born to mothers without thyrotoxicosis or ATD. The risk of neonatal intensive care unit (NICU) admission was also higher with maternal thyrotoxicosis (OR 1.30 [1.07-1.59]) and ATD exposure (OR 1.64 [CI 1.26-2.13]), adjusting for prematurity. Congenital malformation rates were low and similar among infants born to mothers with thyrotoxicosis or ATD exposure (30-44 per 1000 infants). CONCLUSIONS: Gestational ATD exposure occurred in 1.29 per 1000 mother-infant pairs while a much larger number had maternal diagnosed thyrotoxicosis but no drug exposure during pregnancy. Infants of mothers with gestational ATD use or diagnosed thyrotoxicosis were more likely to be preterm and admitted to the NICU. The rates of congenital malformation were low for mothers diagnosed with thyrotoxicosis and did not differ by ATD use. Among women with gestational PTU therapy, the frequency of PTU-associated hepatotoxicity was 1.8 per 1000 delivered pregnancies. These findings from a large, population-based cohort provide generalizable estimates of maternal and infant risks associated with maternal thyrotoxicosis and related pharmacotherapy.

Reduction of soluble CD163, substance P, programmed death 1 and inflammatory markers: phase 1B trial of aprepitant in HIV-1-infected adults.

OBJECTIVE: We evaluated safety, antiviral, immunomodulatory and anti-inflammatory properties of aprepitant - a neurokinin 1 receptor antagonist. DESIGN: Phase IB randomized, placebo-controlled, double-blinded study. METHODS: Eighteen patients were randomized (nine to aprepitant and nine to placebo). The patients received once-daily treatment (375 mg aprepitant or placebo by oral administration) for 2 weeks and were followed off drug for 4 weeks. RESULTS: There were no significant changes in the plasma viremia or CD4(+) T cells during the dosing period. Aprepitant treatment was associated with significant decreases of median within patient change in percentages of CD4(+) T cells expressing programmed death 1 (-4.8%; P = 0.04), plasma substance P (-34.0 pg/ml; P = 0.05) and soluble CD163 (-563 ng/ml; P = 0.02), with no significant changes in the placebo arm. Mean peak aprepitant plasma concentration on day 14 was 7.6 ± 3.1 µg/ml. The use of aprepitant was associated with moderate increases in total cholesterol, low-density lipoprotein and high-density lipoprotein (median change = +31 mg/dl, P = 0.01; +26 mg/dl, P = 0.02; +3 mg/dl, P = 0.02, respectively). CONCLUSION: Aprepitant was safe and well tolerated. At the dose used in this proof-of-concept phase IB study, aprepitant did not show a significant antiviral activity. Aprepitant-treated patients had decreased numbers of CD4(+) programmed death 1-positive cells and decreased plasma levels of substance P and soluble CD163, suggesting that blockade of the neurokinin 1 receptor pathway has a role in modulating monocyte activation in HIV infection. Prospective studies in virologically-suppressed individuals are warranted to evaluate the immunomodulatory properties of aprepitant. Exposures exceeding those attained in this trial are more likely to elicit clinical benefit.

Evaluation of the effect of human immunodeficiency virus-related structural interventions: the connect to protect project.

IMPORTANCE: With the emphasis on structural-level interventions that target social determinants of human immunodeficiency virus (HIV) transmission to curb the HIV epidemic, there is a need to develop evaluation models that can detect changes in individual factors associated with HIV-related structural changes. OBJECTIVE: To describe whether structural changes developed and achieved by community coalitions are associated with an effect on individual factors associated with the risk of contracting HIV. DESIGN, SETTING, AND PARTICIPANTS: In this serial cross-sectional survey design, data were collected from 8 cities during 4 rounds of annual surveys from March 13, 2007, through July 29, 2010. Study recruitment took place at venues where the population of focus was known to congregate, such as clubs, bars, community centers, and low-income housing. The convenience sample of at-risk youth (persons aged 12-24 years) included 5337 individuals approached about the survey and 3142 (58.9%) who were screened for eligibility. Of the 2607 eligible participants, 2559 (98.2%) ultimately agreed to participate. INTERVENTIONS: Achievement of locally identified structural changes that targeted public and private entities (eg, federal agencies, homeless shelters, and school systems) with the goal of fostering changes in policy and practice to ultimately facilitate positive behavioral changes aimed at preventing HIV. MAIN OUTCOMES AND MEASURES: Number of sexual partners, partner characteristics, condom use, and history of sexually transmitted infections and HIV testing. RESULTS: Exposure to structural changes was not statistically significantly associated with any of the outcome measures, although some results were in the direction of a positive structural change effect (eg, a 10-unit increase in a structural change score had an odds ratio of 0.88 [95% CI, 0.76-1.03; P = .11] for having an older sexual partner and an odds ratio of 0.91 [95% CI, 0.60-1.39; P = .39] for using a condom half the time or less with a casual partner). CONCLUSIONS AND RELEVANCE: This study evaluated a broad representation of at-risk individuals and assessed the effect of numerous structural changes related to various HIV risk factors. No structural changes as measured in this study were associated with a statistically significant reduction in risk behaviors. These null findings underscore the need for a long-term approach in evaluating structural interventions and the development of more nuanced methods of quantifying and comparing structural-change initiatives and determining the appropriate strategies for evaluating effect.

A comparison of network-based strategies for screening at-risk Hispanic/Latino adolescents and young adults for undiagnosed asymptomatic HIV infection.

PURPOSE: Hispanic/Latino adolescents and young adults are disproportionately impacted by the HIV/AIDS epidemic; yet little is known about the best strategies to increase HIV testing in this group. Network-based approaches are feasible and acceptable means for screening at-risk adults for HIV infection, but it is unknown whether these approaches are appropriate for at-risk young Hispanics/Latinos. Thus, we compared an alternative venue-based testing (AVT) strategy with a social and sexual network-based interviewing and HIV testing (SSNIT) strategy. METHODS: All participants were Hispanics/Latinos aged 13-24 years with self-reported HIV risk; they were recruited from 11 cities in the United States and Puerto Rico and completed an audio computer-assisted self-interview and underwent HIV screening. RESULTS: A total of 1,596 participants (94.5% of those approached) were enrolled: 784 (49.1%) through AVT and 812 (50.9%) through SSNIT. HIV infection was identified in three SSNIT (.37%) and four AVT (.51%) participants (p = .7213). CONCLUSIONS: Despite high levels of HIV risk, a low prevalence of HIV infection was identified with no differences by recruitment strategy. We found overwhelming support for the acceptability and feasibility of AVT and SSNIT for engaging and screening at-risk young Hispanics/Latinos. Further research is needed to better understand how to strategically implement such strategies to improve identification of undiagnosed HIV infection.

Prevalence of thyrotoxicosis, antithyroid medication use, and complications among pregnant women in the United States.

BACKGROUND: Population-based estimates of the prevalence of thyrotoxicosis (TTX), the frequency of antithyroid drug (ATD) use, and risk of adverse events in pregnant women and their infants are lacking. Therefore, our objective was to obtain epidemiologic estimates of these parameters within a large population-based sample of pregnant women with TTX. METHODS: A retrospective claims analysis was performed from the MarketScan Commercial Claims and Encounters health insurance database for the period 2005-2009. Women aged 15-44 years, enrolled for at least 2 years, and who had a pregnancy during the study period were included. Diagnosis of TTX was based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes using narrow (TTX-1=ICD 242.0) and broad (TTX-2=ICD 242.0 or 242.9) definitions. ATD use was based on prescriptions filled for propylthiouracil (PTU) or methimazole (MMI). Adverse events in mothers and infants were determined from the ICD-9-CM diagnosis codes recorded on submitted claims. RESULTS: The database contained 904,497 eligible women. The average yearly prevalence per 1000 pregnant women was 2.46 for TTX-1 and 5.88 for TTX-2. Thirty-nine percent used ATD at any time during the study period. Compared to women without a TTX diagnosis, there was more than a twofold increase for liver disease among women with TTX (odds ratio [OR]=2.08, p<0.001) and a 13% increased risk for congenital anomalies (OR=1.13, p=0.014), but no association was observed with ATD use. The rates of congenital defects (per 1000 infants) associated with ATD use were 55.6 for MMI, 72.1 for PTU, and 65.8 for untreated women with TTX, compared to 58.8 among women without TTX. CONCLUSIONS: There was some indication of an elevated risk of liver disease and congenital anomalies in women with TTX, but the risk did not appear to be related to the ATD use. There seems to be a higher pregnancy termination rate for women with TTX on MMI, which likely reflects elective pregnancy terminations.

Purpose, structure, and function of the United States National Dental Practice-Based Research Network.

OBJECTIVE: Following a successful 2005-2012 phase with three regional practice-based research networks (PBRNs), a single, unified national network called "The National Dental PBRN" was created in 2012 in the United States to improve oral health by conducting practice-based research and serving dental professionals through education and collegiality. METHODS: Central administration is based in Alabama. Regional centres are based in Alabama, Florida, Minnesota, Oregon, New York and Texas, with a Coordinating Centre in Maryland. Ideas for studies are prioritized by the Executive Committee, comprised mostly of full-time clinicians. RESULTS: To date, 2763 persons have enrolled, from all six network regions; enrollment continues to expand. They represent a broad range of practitioners, practice types, and patient populations. Practitioners are actively improving every step of the research process, from idea generation, to study development, field testing, data collection, and presentation and publication. CONCLUSIONS: Practitioners from diverse settings are partnering with fellow practitioners and academics to improve clinical practice and meet the needs of clinicians and their patients. CLINICAL SIGNIFICANCE: This "nation's network" aims to serve as a precious national resource to improve the scientific basis for clinical decision-making and foster movement of the latest evidence into routine practice.

A randomized, placebo controlled, double masked phase IB study evaluating the safety and antiviral activity of aprepitant, a neurokinin-1 receptor antagonist in HIV-1 infected adults.

BACKGROUND: Neurokinin-1 receptor (NK1R) antagonists have anti-HIV activity in monocyte-derived macrophages, decrease CCR5 expression and improve natural killer cell function ex vivo. Aprepitant is a NK1R antagonist approved by FDA as an antiemetic. METHODS: We conducted a phase IB randomized, placebo controlled, double masked study to evaluate the safety, antiviral activity, pharmacokinetics and immune-modulatory effects of aprepitant in HIV-infected adults not receiving antiretroviral therapy, with CD4+ cell count ≥350 cells/mm(3) and plasma viral load ≥2,000 copies/ml. Subjects were stratified by viral load (< vs. ≥20,000 copies/ml) and randomized within each stratum to receive aprepitant at 125 mg QD(Low), or 250 mg QD(High), or placebo(PL) for 14 days, and followed for 42 days. RESULTS: Thirty subjects were randomized and 27 completed treatment (9, 8, 10 subjects in 125 (Low), 250 (High), and PL groups). 63% were male; 37% white; mean (SD) age 43 (9.3) years. Geometric mean baseline viral load (copies/ml) for Low, High, and PL was 15,709, 33,013, and 19,450, respectively. Mean (95%CI) change in log10 viral load at day 14 for Low, High, and PL was -0.02(-0.24,+0.20), -0.05(-0.21,+0.10), and +0.04(-0.08,+0.16), respectively. The number of subjects with AEs was 4(44.4%), 5(62.5%), and 1(10%) for Low, High, and PL. No Grade 4 AEs occurred. CONCLUSIONS: Adverse events of aprepitant were more common in the treated groups. At the dose used in this two-week phase IB study, aprepitant showed biological activity, but no significant antiviral activity. TRIAL REGISTRATION: ClinicalTrials.gov NCT00428519.

Both human immunodeficiency virus-infected and human immunodeficiency virus-exposed, uninfected children living in Brazil, Argentina, and Mexico have similar rates of low concentrations of retinol, beta-carotene, and vitamin E.

Our objective was to describe the prevalence of low concentrations of retinol, beta-carotene, and vitamin E in a group of human immunodeficiency virus (HIV)-infected Latin American children and a comparison group of HIV-exposed, uninfected children. Our hypothesis was that the rates of low concentrations of these micronutrients would be higher in the HIV-infected group than those in the HIV-exposed, uninfected group. This was a cross-sectional substudy of a larger cohort study at clinical pediatric HIV centers in Latin America. Serum levels of micronutrients were measured in the first stored sample obtained after each child's first birthday by high-performance liquid chromatography. Low concentrations of retinol, beta-carotene, and vitamin E were defined as serum levels below 0.70, 0.35, and 18.0 micromol/L, respectively. The population for this analysis was 336 children (124 HIV-infected, 212 HIV-exposed, uninfected) aged 1 year or older to younger than 4 years. Rates of low concentrations were 74% for retinol, 27% for beta-carotene, and 89% for vitamin E. These rates were not affected by HIV status. Among the HIV-infected children, those treated with antiretrovirals were less likely to have retinol deficiency, but no other HIV-related factors correlated with micronutrient low serum levels. Low concentrations of retinol, beta-carotene, and vitamin E are very common in children exposed to HIV living in Brazil, Argentina, and Mexico, regardless of HIV-infection status.

Asthma-related medication use among children in the United States.

BACKGROUND: Asthma is one of the most common chronic conditions in children and has a major impact on health care use and quality of life. The Best Pharmaceuticals for Children Act mandates the federal government to sponsor pediatric studies of drugs approved for use in the United States but lacking evaluation in the pediatric population and lacking interest of commercial sponsors. As input into the drug selection and prioritization process, information is needed on the percentage of children who receive asthma-related medications. OBJECTIVE: To estimate the percentage of children who receive asthma-related medications. METHODS: Retrospective analysis of outpatient medical and drug claims from members of commercial health care insurance plans enrolled any time from January 1, 2004, through December 31, 2005. The study population included 4,259,103 children throughout the United States aged birth through 17 years. RESULTS: Fifteen percent of all children were dispensed an asthma-related medication. Among 218,943 children with an asthma diagnosis, 188,286 (86%) had a dispensed asthma-related medication at any time during the 2-year study period. Among children without any asthma diagnoses, 398,880 (10%) had a dispensed medication. Fifty-nine percent of children with an asthma diagnosis were dispensed an anti-inflammatory medication within 90 days after a claim with a diagnosis of asthma. CONCLUSIONS: Asthma-related medications are dispensed to a large percentage of the pediatric population, including many who do not have claims with asthma diagnoses listed. Data on the pharmacokinetics and safety of these drugs in children are largely unknown and difficult to obtain. Clinical studies that use new tools and approaches are needed to resolve this information gap.

Infectious disease morbidity among young HIV-1-exposed but uninfected infants in Latin American and Caribbean countries: the National Institute of Child Health and Human Development International Site Development Initiative Perinatal Study.

OBJECTIVE: The goal was to describe the frequency, characteristics, and correlates of infectious disease morbidity during the first 6 months of life among HIV-1-exposed but uninfected infants. METHODS: The study population consisted of infants enrolled in the National Institute of Child Health and Human Development International Site Development Initiative Perinatal Study who were HIV-1 uninfected and had follow-up data through the 6-month study visit. Definitive and presumed infections were recorded at study visits (birth, 6-12 weeks, and 6 months). RESULTS: Of 462 HIV-1-uninfected infants with 11,644 child-weeks of observation, 283 experienced > or = 1 infection. These 283 infants experienced 522 infections (1.8 infections per infant). The overall incidence rate of infections was 4.5 cases per 100 child-weeks of observation. Overall, the most common infections were skin or mucous membrane infections (1.9 cases per 100 child-weeks) and respiratory tract infections (1.7 cases per 100 child-weeks). Thirty-six percent of infants had > 1 respiratory tract infection (1.8 cases per 100 child-weeks). Incidence rates of upper and lower respiratory tract infections were similar (0.89 cases per 100 child-weeks and 0.9 cases per 100 child-weeks, respectively). Cutaneous and/or oral candidiasis occurred in 48 neonates (10.3%) and 92 older infants (19.3%). Early neonatal sepsis was diagnosed in 12 infants (26.0 cases per 1000 infants). Overall, 81 of 462 (17.5%) infants were hospitalized with an infection. Infants with lower respiratory tract infections were hospitalized frequently (40.7%). The occurrence of > or = 1 neonatal infection was associated with more-advanced maternal HIV-1 disease, tobacco use during pregnancy, infant anemia, and crowding. Lower maternal CD4+ cell counts, receipt of intrapartum antibiotic treatment, and country of residence were associated with postneonatal infections. CONCLUSIONS: Close monitoring of HIV-1-exposed infants, especially those who are anemic at birth or whose mothers have more-advanced HIV-1 disease or who smoked during pregnancy, remains important.