ABSTRACT. Objective. The complexity of highly active antiretroviral therapy (HAART), with multiple medications, formulations, and dosing intervals, makes adherence challenging. Little is known about the adherence of children to HAART. The objective of this study was to identify correlates of adherence to HAART and the relationship between adherence and study outcomes in a pediatric clinical trial.Methods. Pediatric AIDS Clinical Trials Group 377 is a phase I/II randomized trial of 4 HAART regimens in antiretroviral-experienced, clinically stable children aged 4 months to 17 years. The 4 treatment arms include various 3-or 4-drug combinations of d4T, 3TC, nevirapine, ritonavir, and nelfinavir. After informed consent was obtained, 193 children were enrolled between December 1997 and September 1998. Questionnaires were developed to collect subject-or caregiver-reported adherence to study medications and to identify problems associated with medication administration. Every 3 months, the number of doses of each medication missed during the 3 days preceding the study visit was recorded. Full adherence (FA) and non-full adherence were defined as missing no doses and missing at least 1 dose, respectively.Results. Adherence data from study week 48 or the most recent study visit were available for 125 children (week 48 for 109 children). Overall, 70% of children reported FA and 30% reported non-full adherence. Adherence did not differ by treatment arm, age, or the child's knowledge of his or her human immunodeficiency virus infection status. There was a suggestion that adherence was less for white than nonwhite children (40% vs 73% FA) and did not differ between black and Hispanic children. Rates of FA were 82% for d4T, 79% for 3TC, 83% for nevirapine, 84% for ritonavir, and 68% for nelfinavir. Despite the similar rates of FA, difficulties with taking specific medications were reported most frequently for ritonavir and nelfinavir. These included poor taste, patient refusal, and scheduling problems. Adherence was associated with the virologic response: FA was seen in 92% of children with >2 log 10 drop in viral load and in 64% with <2 log 10 drop in viral load.Conclusion. In children, reported adherence predicts the virologic response to HAART therapy and is a useful measure of adherence. Interventions and regimens to increase adherence to HAART should result in an improved outcome. Pediatrics 2002;109(4). URL: http:// www.pediatrics.org/cgi/content/full/109/4/e61; adherence, compliance, HIV, antiretroviral therapy, protease inhibitors.ABBREVIATIONS. HAART, highly active antiretroviral therapy; HIV, human immunodeficiency virus; PACTG, Pediatric AIDS Clinical Trials Group; RT, reverse transcriptase; BID, twice-daily; TID, 3 times a day; FA, full adherence; NFA, non-full adherence.H ighly active combination antiretroviral therapy (HAART) is effective in suppressing human immunodeficiency virus (HIV) replication, preventing opportunistic infections, reducing mortality, and improving the well-being of children and adults with...

Background The purpose of this study was to examine 1) the prevalence of psychiatric and substance use disorders in perinatally HIV-infected (HIV+) adolescents and 2) the association between HIV infection and these mental health outcomes by comparing HIV+ youths to HIV exposed but uninfected youths (HIV-) from similar communities. Methods Data for this paper come from the baseline interview of a longitudinal study of mental health outcomes in 9-16 year old perinatally HIV-exposed youths (61% HIV+) and their caregivers. Three hundred forty youths and their primary adult caregivers were recruited from four medical centers and participated in separate individual interviews. Youth psychiatric disorder was assessed using the caregiver and youth versions of The Diagnostic Interview Schedule for Children (DISC-IV). Results According to caregiver or youth report, a high percentage of HIV+ and HIV- youths met criteria for a non-substance use psychiatric disorder, with significantly higher rates among the HIV+ youths (61% vs 49%, OR=1.59; CI=1.03,2.47; p < .05). The most prevalent diagnoses in both groups were anxiety disorders (46% for total sample) which included social phobia, separation anxiety, agoraphobia, generalized anxiety disorder, panic disorder, obsessive- compulsive disorder, and specific phobias. One quarter of the sample met criteria for a behavioral disorder (ADHD, conduct disorders, and oppositional defiant disorders), with ADHD being most prevalent. HIV+ youths had significantly higher rates of ADHD (OR=2.45; CI=1.20, 4.99, p < .05). Only 7% of youths met criteria for a mood disorder and 4% for a substance abuse disorder. Several caregiver variables (caregiver type and HIV status) were also associated with both child HIV status and mental health outcomes. Conclusions Our data suggest that HIV+ youths are at high risk for mental health disorders. Further longitudinal research is necessary to understand the etiology, as well as potential protective factors, in order to inform efficacy-based interventions.

V␣24 natural killer T (NKT) cells are innate immune cells involved in regulation of

Clinically and immunologically stable HIV-infected children had more frequent behavioral problems and lower developmental and cognitive scores than established childhood norms.

As the pediatric HIV epidemic in resource-rich countries evolves into an adolescent epidemic, there is a substantive need for studies elucidating mental health needs of perinatally HIV-infected (PHIV+) youth as they transition through adolescence. This article examines the role of perinatal HIV infection in influencing mental health by comparing changes in psychiatric disorders and substance use disorders (SUD) in perinatally HIV-infected (PHIV+) and perinatally HIV-exposed, but uninfected (PHIV−) youth over time. Participants were recruited from four medical centers in New York City. Individual interviews were administered at baseline and 18-month follow-up to 166 PHIV+ and 114 PHIV-youth (49% male, age 9–16 at baseline). Youth psychiatric disorder was assessed using the caregiver and youth versions of the Diagnostic Interview Schedule for Children (DISC-IV). Over two-thirds of participants met criteria for at least one psychiatric disorder at either baseline or follow-up, with few group differences. Among PHIV+ youth, there was a significant decrease in the prevalence of any psychiatric disorder, as well as anxiety disorders specifically over time, while prevalence of any psychiatric disorder among PHIV− youth remained the same and mood disorders increased. Rates of SUD were low in both groups, increasing slightly by follow-up. PHIV+ youth reported more use of mental health services at follow-up. CD4 count and HIV RNA Viral Load were not associated with presence or absence of disorder at either time point. In conclusion, among PHIV+ and PHIV− youth, rates of psychiatric disorder were high, even compared to other vulnerable populations, suggesting that factors other than perinatal HIV infection may be important determinants of mental health. PHIV+ youth were more likely to improve over the observation period. The data underscore the critical need for mental health interventions for both PHIV+ and PHIV− youth.

In our study, change in antiretroviral therapy to a ritonavir-containing regimen was associated with superior virologic response at study week 12 compared with change to a dual nucleoside analog regimen. More children receiving ritonavir in combination with 2 compared with 1 nucleoside analog had undetectable HIV RNA levels at study week 48.

Introduction Pediatric asthma is a serious public health problem around the world. The World Health Organization estimated that approximately 300 million people currently have asthma worldwide, and with current trends rising, it is expected to reach 400 million by 2025 [1]. Nearly 250,000 people die prematurely each year from asthma, and most of all these deaths are preventable. Globally, death rates from asthma in children range from 0 to 0.7 per 100,000 people [2]. Among children, asthma is the most common chronic disease, ranking among the top 20 conditions worldwide for disability-adjusted life years in children [3]. Increasing Prevalence The most accurate information regarding the prevalence of asthma in children around the world is available from the International Study of Asthma and Allergies in Childhood (ISAAC). Phase I of this study was completed in 1994-1995 and involved over 700,000 schoolchildren aged 6-7 and 13-14 years from 56 countries. The study revealed marked geographic variations in the prevalence of asthma. Countries with low prevalence of asthma (2-4%) were mostly in Asia, Northern Africa, Eastern Europe, and Eastern Mediterranean regions, whereas countries with high prevalence (29-32%) were located in South East Asia, North America and Latin America [4, 5] Phase III of ISAAC was conducted during 2000-2003 and involved over 1,100,000 school children from 98 countries [5-7].

The CYP2B6-G516T genotype alters NVP pharmacokinetics and the immunologic response to NVP-containing HAART regimens in children. These data suggest that the CYP2B6-G516T is an important genetic variant that alters the pharmacokinetics and response to HAART regimens containing NVP.