Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding.

IMPAACT PROMISE 1077BF/FF was a sequentially randomized study of pregnant and postpartum women living with HIV to investigate the efficacy and safety of antiretroviral therapy (ART). This Maternal Health Component investigated efficacy for the risk of developing AIDS or death; and safety among women randomized to continue ART (CTART: N = 289) or discontinue ART (N = 268) after cessation of breastfeeding or after confirmation of infant infection. No AIDS-defining illnesses were reported during follow-up in either arm.

Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions.

Background: We describe enrollment and accrual challenges in the "Promoting Maternal and Infant Survival Everywhere" (PROMISE) trial conducted in resource-limited countries, as well as the challenges in transitioning participants from the antepartum to the postpartum components of the study.

Methods: PROMISE was a large multi-national randomized controlled trial of the safety and efficacy of interventions to reduce perinatal transmission of HIV-1 (HIV) during pregnancy and breastfeeding and of interventions to preserve maternal health after cessation of perinatal transmission risk. The PROMISE study included two protocols for HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment.

The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.

Background: Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes.

Methods: HIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine.

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial.

Background: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery.

Methods: Women with pre-ART CD4+ cell counts ≥350 cells/mm who started ART during pregnancy were randomized postpartum to continue or discontinue treatment.

Metabolic effects of initiating lopinavir/ritonavir-based regimens among young children.

Objective: The aim of this study was to estimate the long-term metabolic effects of initiating a lopinavir/ritonavir (LPV/r)-based regimen as a first-line therapy for HIV-infected children less than 3 years of age in resource-limited settings.

Design: A prospective cohort study after conclusion of the P1060 randomized clinical trials (ClinicalTrials.gov Identifier: NCT00307151), with an overall follow-up of 7 years.

Assessing Psychiatric Symptoms in Youth Affected by HIV: Comparing a Brief Self-Administered Rating Scale with a Structured Diagnostic Interview.

Brief psychiatric assessment tools are needed for evaluating children affected by HIV for emotional and behavioral problems. We compared a self-administered symptom rating scale (CASI-4R) to a semi-structured diagnostic interview (DICA-P) in 136 U.S.

Changes in Inflammation but Not in T-Cell Activation Precede Non-AIDS-Defining Events in a Case-Control Study of Patients on Long-term Antiretroviral Therapy.

Background: We examined changes in soluble inflammatory cytokines and T-cell activation after antiretroviral therapy (ART) initiation in an AIDS Clinical Trials Group (ACTG) nested case-control study.

Methods: Cases were 143 human immunodeficiency virus (HIV)-infected adults who developed a non-AIDS event; 315 controls remained event-free. Specimens were tested pre-ART, year 1 post-ART, and at the visit preceding the event.

Defining Study Outcomes That Better Reflect Individual Response to Treatment.

Background: Most clinical trials comparing treatments evaluate the separate effects on each of several efficacy and toxicity outcomes. However, population-averaged summary measures of treatment differences may not accurately reflect individual responses to treatment, and drawing conclusions about which treatment is "best" is straightforward if one treatment is superior across all outcomes, but challenging when this is not the case.

Methods: We created a study outcome based on expert opinion, which captures the risk/benefit profile of response to a treatment.

Novel Method Suggests Global Superiority of Short-Duration Antibiotics for Intra-abdominal Infections.

Desirability of outcome ranking and response adjusted for duration of antibiotic risk (DOOR/RADAR) are novel and innovative methods of evaluating data in antibiotic trials. We analyzed data from a noninferiority trial of short-course antimicrobial therapy for intra-abdominal infection (STOP-IT), and results suggest global superiority of short-duration therapy for intra-abdominal infections.

Nevirapine- Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy in HIV-Infected Infants and Young Children: Long-term Follow-up of the IMPAACT P1060 Randomized Trial.

Background: The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1060 study demonstrated short-term superiority of lopinavir/ritonavir (LPV/r) over nevirapine (NVP) in antiretroviral therapy (ART), regardless of prior NVP exposure. However, NVP-based ART had a marginal benefit in CD4 percentage (CD4%) and growth. We compared 5-year outcomes from this clinical trial.

Killer Cell Immunoglobulin-Like Receptor Alleles Alter HIV Disease in Children.

Background: HLA class I molecules are ligands for killer cell immunoglobin like receptors (KIR) that control the antiviral response of natural killer (NK) cells. However, the effects of KIR and HLA (KIR/HLA) alleles on HIV disease of children have not been studied.

Methods: 993 antiretroviral naïve children with symptomatic HIV infection from PACTG protocols P152 and P300 were genotyped for KIR and HLA alleles using the Luminex platform.

Psychiatric symptoms and antiretroviral nonadherence in US youth with perinatal HIV: a longitudinal study.

Objectives: The relationship of specific psychiatric conditions to adherence has not been examined in longitudinal studies of youth with perinatal HIV infection (PHIV). We examined associations between psychiatric conditions and antiretroviral nonadherence over 2 years.

Design: Longitudinal study in 294 PHIV youth, 6-17 years old, in the United States and Puerto Rico.

Participation and retention of youth with perinatal HIV infection in mental health research studies: the IMPAACT P1055 psychiatric comorbidity study.

Background: Obtaining accurate estimates of mental health problems among youth perinatally infected with HIV (PHIV) helps clinicians develop targeted interventions but requires enrollment and retention of representative youth into research studies.

Methods: The study design for IMPAACT P1055, a US-based, multisite prospective study of psychiatric symptoms among PHIV youth and uninfected controls aged 6 to 17 years old, is described. Participants were compared with nonparticipants by demographic characteristics and reasons were summarized for study refusal.

Longitudinal study of emerging mental health concerns in youth perinatally infected with HIV and peer comparisons.

Objective: Cross-sectional research indicates high rates of mental health concerns among youth with perinatal HIV infection (PHIV), but few studies have examined emerging psychiatric symptoms over time.

Methods: Youth with PHIV and peer comparisons who were HIV-exposed but uninfected or living in households with HIV-infected family members (HIV-affected) and primary caregivers participated in a prospective, multisite, longitudinal cohort study. Groups were compared for differences in the incidence of emerging psychiatric symptoms during 2 years of follow-up and for differences in psychotropic drug therapy.

Maternal and fetal circulating sKL and ET-1 levels as function of normal labor at term.

Objectives: To determine whether labor is associated with alterations of the levels of soluble c-kit ligand (sKL) and endothelin-1 (ET-1) in maternal plasma and umbilical cord blood.

Methods: The sKL and ET-1 levels were investigated in umbilical cord and maternal plasma on the day of delivery in 18 pregnant women with vaginal delivery during labor, 18 non-pregnant women and 9 pregnant women before cesarean delivery, using an ELISA assay.

Results: Umbilical cord plasma sKL levels were significantly higher than the maternal plasma in both types of delivery (p = 0.

Total occlusion of the common carotid artery: a modified classification and its relation to clinical status.

To investigate the hemodynamics and clinical presentation of common carotid artery occlusion (CCAO), we reviewed 6,415 patients with suspected carotid artery disease in whom a color Duplex imaging (CDI) examination was performed. According to distal vessel patency, the following CDI classification of CCAO was adopted: type I (patent both distal vessels); type II (isolated patency of external carotid artery); type III (isolated patency of internal carotid artery); and type IV (both distal vessels occluded). Thirty-five (0.