Biologic and social determinants of sequelae and long-term survival of pediatric HIV in Romania.

PURPOSE: The aim of the study is to investigate the effect of social context and clinical factors on survival in a cohort of 333 children to identify issues useful in the treatment and care of human immunodeficiency virus (HIV)-infected youth in developing countries. METHODS: A prospective cohort study design was used, and data were gathered at baseline and 1-year follow-up. The study cohort consisted of children given a diagnosis of HIV between 1995 and 1999 and receiving medical care in Constanta, Romania. Data were examined by means of multivariate Cox regression analysis models. RESULTS: The majority of the cohort were in the moderate (41%) or severe (40%) stages of HIV at baseline. Multivariate analysis indicated that social-context factors were the most significant determinants of HIV survival. The hazard for death for those with mothers or fathers with a higher level of education was approximately one quarter (relative hazard, 0.3-0.4; confidence interval, 0.1-1.0) that for a parent with a lower level of education. Subjects with employed mothers were four times more likely to survive than subjects with unemployed mothers. CONCLUSIONS: Results suggest that recognition of social-context risk factors for HIV disease progression and survival is important in developing countries, as it is in developed countries.

Demographic and spatial analysis of West Nile virus and St. Louis encephalitis in Houston, Texas.

This descriptive prevalence study describes the relationships between mosquito density and the presence of arboviruses (in mosquitoes and humans) with various socioeconomic and environmental factors present near the time of teh arbovirus outbreak in Harris County, Texas, in 2002. This study suggests that mosquito density increased if the trap was located in an area with a large number of containers that may inadvertently retain rainwater (P = 0.056). When considering only virus-positive mosquitoes, significant relationships were observed if the trap was located near waste materials (P < 0.001) or near containers that may inadvertently retain rainwater (P = 0.037). Furthermore, the presence of arbovirus activity (in mosquitoes or humans) in a geographic area tended to be associated with the socioeconomic status of the local community. Although the results of socioeconomic comparisons were not significant, they were suggestive, demonstrating an interesting trend. Compared with communities where virus activity was not observed, the socioeconomic status of the arbovirus-positive community was consistently lower. Specifically, results showed that the populations residing in virus-positive census tracts attained less education, earned less income per household, and were more likely to be below the poverty level. In addition, this study found that virus-positive mosquitoes were randomly distributed throughout the study area, whereas severe human infection cases were clustered. Based on the results of this study, we conclude that the health outcome of a local community as it relates to West Nile virus and St. Louis encephalitis is dependent on many factors, including eh socioeconomic and environmental characteristics of the community.

Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) play key roles in making safe and effective medical devices available to the public. Since 1997 Congress has passed "modernization" laws that specify statutory deadlines for these agencies to review manufacturers' applications for premarket approval--the process by which the FDA evaluates the safety and effectiveness of class III medical devices, those that pose the highest risk--and applications for national coverage by Medicare. We questioned whether these reforms shortened approval time at the FDA and CMS. We searched publicly available databases for information for the period from January 1, 1995, through December 31, 2008, and calculated median time to approval. After initially declining, the FDA median approval time increased after 2002 and nearly reached the 1997 prereform levels by the end of the study period. In contrast, the CMS median approval time decreased steadily over the period. Neither agency consistently met the statutory deadline of 180 days for approval of premarket applications or national coverage. Congress should consider the underlying causes for these delays in the development of future modernization legislation.

Alternatives to HIV-RNA and CD4 count to monitor HIV disease progression: a prospective cohort study in Romania.

Little evidence exists on how to efficiently and effectively monitor HIV-disease progression in developing countries. Better understanding regarding cost-effective tests may help to resolve questions regarding treatment. A prospective cohort study was conducted with a 1-year follow-up period. Immune complex-dissociated (ICD) p24 antigen (ICD p24Ag), alone or in combination with HIV p24 antibody (p24Ab), was compared to HIV-RNA and CD4+ count in a cohort of 160 HIV-infected adolescents in Romania. The main outcome measure was disease progression, defined as >50,000 copies/ml of HIV-RNA or death. Among the 160 adolescents, a higher mean ICD p24Ag was significantly associated with clinical disease classification (CDC), plasma HIV-RNA concentration, and p24Ab. Multivariate logistic regression showed detectable ICD p24Ag had an odds ratio of 3.7 (95% CI 1.4-9.7) for disease progression in comparison to undetectable ICD p24Ag. ICD p24Ag is of value in determining the prognosis of disease in HIV-1-infected adolescents in developing countries. Additional studies for validation of this assay for HIV clades primarily affecting developing countries, are now needed.