High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial.

INTRODUCTION: Phase 2 clinical trials of tuberculosis treatment have shown that once-daily regimens in which rifampin is replaced by high dose rifapentine have potent antimicrobial activity that may be sufficient to shorten overall treatment duration. Herein we describe the design of an ongoing phase 3 clinical trial testing the hypothesis that once-daily regimens containing high dose rifapentine in combination with other anti-tuberculosis drugs administered for four months can achieve cure rates not worse than the conventional six-month treatment regimen. METHODS/DESIGN: S31/A5349 is a multicenter randomized controlled phase 3 non-inferiority trial that compares two four-month regimens with the standard six-month regimen for treating drug-susceptible pulmonary tuberculosis in HIV-negative and HIV-positive patients. Both of the four-month regimens contain high-dose rifapentine instead of rifampin, with ethambutol replaced by moxifloxacin in one regimen. All drugs are administered seven days per week, and under direct observation at least five days per week. The primary outcome is tuberculosis disease-free survival at twelve months after study treatment assignment. A total of 2500 participants will be randomized; this gives 90% power to show non-inferiority with a 6.6% margin of non-inferiority. DISCUSSION: This phase 3 trial formally tests the hypothesis that augmentation of rifamycin exposures can shorten tuberculosis treatment to four months. Trial design and standardized implementation optimize the likelihood of obtaining valid results. Results of this trial may have important implications for clinical management of tuberculosis at both individual and programmatic levels. TRIAL REGISTRATION: NCT02410772. Registered 8 April 2015,https://www.clinicaltrials.gov/ct2/show/NCT02410772?term=02410772&rank=1.

Postpartum changes in plasma viral load and CD4 percentage among HIV-infected women from Latin American and Caribbean countries: the NISDI Perinatal Study.

The goal of this study was to evaluate changes in plasma human immunodeficiency virus (HIV) RNA concentration [viral load (VL)] and CD4+ percentage (CD4%) during 6-12 weeks postpartum (PP) among HIV-infected women and to assess differences according to the reason for receipt of antiretrovirals (ARVs) during pregnancy [prophylaxis (PR) vs. treatment (TR)]. Data from a prospective cohort of HIV-infected pregnant women (National Institute of Child Health and Human Development International Site Development Initiative Perinatal Study) were analyzed. Women experiencing their first pregnancy who received ARVs for PR (started during pregnancy, stopped PP) or for TR (initiated prior to pregnancy and/or continued PP) were included and were followed PP. Increases in plasma VL (> 0.5 log10) and decreases in CD4% (> 20% relative decrease in CD4%) between hospital discharge (HD) and PP were assessed. Of the 1,229 women enrolled, 1,119 met the inclusion criteria (PR: 601; TR: 518). At enrollment, 87% were asymptomatic. The median CD4% values were: HD [34% (PR); 25% (TR)] and PP [29% (PR); 24% (TR)]. The VL increases were 60% (PR) and 19% (TR) (p < 0.0001). The CD4% decreases were 36% (PR) and 18% (TR) (p < 0.0001). Women receiving PR were more likely to exhibit an increase in VL [adjusted odds ratio (AOR) 7.7 (95% CI: 5.5-10.9) and a CD4% decrease (AOR 2.3; 95% CI: 1.6-3.2). Women receiving PR are more likely to have VL increases and CD4% decreases compared to those receiving TR. The clinical implications of these VL and CD4% changes remain to be explored.

Postpartum changes in plasma viral load and CD4 percentage among HIV-infected women from Latin American and Caribbean countries: the NISDI Perinatal Study

The goal of this study was to evaluate changes in plasma human immunodeficiency virus (HIV) RNA concentration [viral load (VL)] and CD4+ percentage (CD4 percent) during 6-12 weeks postpartum (PP) among HIV-infected women and to assess differences according to the reason for receipt of antiretrovirals (ARVs) during pregnancy [prophylaxis (PR) vs. treatment (TR)]. Data from a prospective cohort of HIV-infected pregnant women (National Institute of Child Health and Human Development International Site Development Initiative Perinatal Study) were analyzed. Women experiencing their first pregnancy who received ARVs for PR (started during pregnancy, stopped PP) or for TR (initiated prior to pregnancy and/or continued PP) were included and were followed PP. Increases in plasma VL (> 0.5 log10) and decreases in CD4 percent (> 20 percent relative decrease in CD4 percent) between hospital discharge (HD) and PP were assessed. Of the 1,229 women enrolled, 1,119 met the inclusion criteria (PR: 601; TR: 518). At enrollment, 87 percent were asymptomatic. The median CD4 percent values were: HD [34 percent (PR); 25 percent (TR)] and PP [29 percent (PR); 24 percent (TR)]. The VL increases were 60 percent (PR) and 19 percent (TR) (p < 0.0001). The CD4 percent decreases were 36 percent (PR) and 18 percent (TR) (p < 0.0001). Women receiving PR were more likely to exhibit an increase in VL [adjusted odds ratio (AOR) 7.7 (95 percent CI: 5.5-10.9) and a CD4 percent decrease (AOR 2.3; 95 percent CI: 1.6-3.2). Women receiving PR are more likely to have VL increases and CD4 percent decreases compared to those receiving TR. The clinical implications of these VL and CD4 percent changes remain to be explored.

Hospitalization of children and adolescents for eating disorders in the State of New York.

PURPOSE: To examine hospitalization patterns, length of stay, cost and insurance status for children and adolescents with Eating Disorders. METHODS: A cross-sectional study was conducted of patients with eating disorders aged 9 to 17 years, discharged from hospitals in the State of New York in 1995. All patients discharged in the state were registered by the State Planning and Research Collaborative System (SPARCS). A subset was identified based on coding by the International Classification of Diseases (ICD) for Anorexia Nervosa, Bulimia and Eating Disturbance Not Otherwise Specified. The Statistical Analysis System (SAS) was used for data analysis. The variables selected were gender, ethnicity, insurance status and length of stay. RESULTS: In one year there were 352 hospitalizations, 312 females (88.6%) and 40 males (11.4%); 279 Caucasians (79.3%), 35 African Americans (9.9%), and 38 Other (10.8%); commercial insurance 246 (69.9%), Medicaid 68 (19.3%), other 38 (10.8%). The diagnostic categories were Anorexia Nervosa 242, Bulimia 59, and Eating Disturbance Not Otherwise Specified 63 (reflecting dual diagnosis in 13). Mean length of stay was 18.43 days, the median was 7 days. The cost per stay ranged between 341.78 dollars and 148,471 dollars; with a median of 3817 dollars and a mean of 10,019 dollars. Length of stay was not influenced by gender, age, or ethnicity; only payor status, availability of insurance, was dominant. CONCLUSIONS: This is the first statewide report on hospitalization of children and adolescents for eating disorders. The mean cost in 1995 exceeded 10,000 dollars. A correlation was found between length of stay and insurance status. Hospitalizations for eating disorder have a significant public health impact, calling for the formulation of fair and rational strategies to optimize care.