Haematological Safety of Perinatal Zidovudine in Pregnant HIV-1–Infected Women in Thailand: Secondary Analysis of a Randomized Trial

OBJECTIVES: To respond to the primary safety objective of the Perinatal HIV Prevention Trial 1 (PHPT-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in HIV-1−infected pregnant women. DESIGN: Multicenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis. SETTING: 27 hospitals in Thailand. PARTICIPANTS: 1,436 HIV-infected pregnant women in PHPT-1. INTERVENTION: Zidovudine prophylaxis initiation at 28 or 35 wk gestation. OUTCOME MEASURES: Haemoglobin level, leucocytes, total lymphocyte counts, and absolute neutrophil counts were measured at 26, 32, and 35 wk and at delivery. The evolution of haematological parameters was estimated between 26 and 35 wk (zidovudine/placebo) and between 35 wk and delivery to compare a long versus short zidovudine exposure. For each parameter, linear mixed models were adjusted on baseline sociodemographic variables, HIV clinical stage, CD4 count, and viral load. RESULTS: Between 26 and 35 wk, haemoglobin, leucocytes, and absolute neutrophil counts decreased in zidovudine-exposed compared to unexposed women (mean difference [95% CI] −0.4 [−0.5 to −0.3], −423 [−703 to −142], −485 [−757 to −213], respectively). However, between 35 wk and delivery, the haematological parameters increased faster in women exposed to long rather than short durations of zidovudine (0.1 [0.0 to 0.1]; 105 [18 to 191]; 147 [59 to 234], respectively). At delivery, the differences were not statistically significant, except for mean haemoglobin level, which remained slightly lower in the long zidovudine treatment group (difference: 0.2 g/dl). Zidovudine had no negative impact on the absolute lymphocyte counts. CONCLUSION: Zidovudine initiated at 28 wk gestation rather than 35 wk had a transient negative impact on the evolution of haematological parameters, which was largely reversed by delivery despite continuation of zidovudine. This result provides reassurance about the safety of early initiation of zidovudine prophylaxis during pregnancy to maximize prevention of perinatal HIV

Toxicité de la zidovudine pour la prévention de la transmission mère-enfant du VIH, en Thaïlande

LE KREMLIN-B.- PARIS 11-BU Méd (940432101) / SudocPARIS-INED-Documentation (751202301) / SudocPARIS-BIUP (751062107) / SudocSudocFranceF

Text message reminders for adolescents with poorly controlled type 1 diabetes: A randomized controlled trial.

BackgroundAmong adolescents with type 1 diabetes, some experience great difficulties with treatment adherence, putting them at high risk of complications. We assessed the effect of text messaging (Short Messaging Service [SMS]) on glycemic control.MethodsA two-arm open label randomized controlled trial enrolled adolescents with type 1 diabetes aged 12-21 years with baseline HbA1c ≥ 69 mmol/mol (8.5%). The intervention group received daily SMS reminders at self-selected times about insulin injections while the control group received standard of care. The patients allocated to the control group were not aware of the intervention.Results92 patients were randomized, 45 in the SMS arm and 47 in the control arm. After 6 months, median HbA1c level was significantly lower in the intervention arm: 73 mmol/mol (8.8%) in the SMS arm and 83 mmol/mol (9.7%) in the control arm in the intent-to-treat analysis (P = 0.03) but no longer in the per protocol analysis (P = 0.65). When we consider the proportions of patients whose HbA1c level decreased by at least 1% between baseline and 6 months, we find a significant difference among patients whose baseline HbA1c was ≥ 80 mmol/mol (9.5%) (n = 56): 60% in the SMS arm and 30.6% in the control arm had lowered their HbA1c level (P = 0.03) in the intent-to-treat analysis but not in the per-protocol analysis (P = 0.50). Patients in the SMS arm reported high satisfaction with the intervention.ConclusionsWhile there is a trend to lower HbA1c in the intervention group, no firm conclusions can yet be drawn. Further studies are needed to address methodological issues as we believe these interventions can support behavior change among adolescents with poorly controlled type 1 diabetes. ClinicalTrials.gov identifier: NCT02230137

Haematological safety of perinatal zidovudine in pregnant HIV-1-infected women in Thailand: Secondary analysis of a randomized trial - art. no. e11

Objectives: To respond to the primary safety objective of the Perinatal HIV Prevention Trial 1 (PHPT-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in HIV-1-infected pregnant women. Design: Multicenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis. Setting: 27 hospitals in Thailand. Participants: 1,436 HIV-infected pregnant women in PHPT-1. Intervention: Zidovudine prophylaxis initiation at 28 or 35 wk gestation. Outcome measures: Haemoglobin level, leucocytes, total lymphocyte counts, and absolute neutrophil counts were measured at 26, 32, and 35 wk and at delivery. The evolution of haematological parameters was estimated between 26 and 35 wk (zidovudine/placebo) and between 35 wk and delivery to compare a long versus short zidovudine exposure. For each parameter, linear mixed models were adjusted on baseline sociodemographic variables, HIV clinical stage, CD4 count, and viral load. Results: Between 26 and 35 wk, haemoglobin, leucocytes, and absolute neutrophil counts decreased in zidovudine-exposed compared to unexposed women ( mean difference [95% CI] - 0.4 [ - 0.5 to - 0.3], - 423 [ - 703 to - 142], - 485 [ - 757 to - 213], respectively). However, between 35 wk and delivery, the haematological parameters increased faster in women exposed to long rather than short durations of zidovudine (0.1 [ 0.0 to 0.1]; 105 [ 18 to 191]; 147 [ 59 to 234], respectively). At delivery, the differences were not statistically significant, except for mean haemoglobin level, which remained slightly lower in the long zidovudine treatment group ( difference: 0.2 g/dl). Zidovudine had no negative impact on the absolute lymphocyte counts. Conclusion: Zidovudine initiated at 28 wk gestation rather than 35 wk had a transient negative impact on the evolution of haematological parameters, which was largely reversed by delivery despite continuation of zidovudine. This result provides reassurance about the safety of early initiation of zidovudine prophylaxis during pregnancy to maximize prevention of perinatal HIV

Haematological safety of perinatal zidovudine in pregnant HIV-1-infected women in Thailand: Secondary analysis of a randomized trial - art. no. e11

Objectives: To respond to the primary safety objective of the Perinatal HIV Prevention Trial 1 (PHPT-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in HIV-1-infected pregnant women. Design: Multicenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis. Setting: 27 hospitals in Thailand. Participants: 1,436 HIV-infected pregnant women in PHPT-1. Intervention: Zidovudine prophylaxis initiation at 28 or 35 wk gestation. Outcome measures: Haemoglobin level, leucocytes, total lymphocyte counts, and absolute neutrophil counts were measured at 26, 32, and 35 wk and at delivery. The evolution of haematological parameters was estimated between 26 and 35 wk (zidovudine/placebo) and between 35 wk and delivery to compare a long versus short zidovudine exposure. For each parameter, linear mixed models were adjusted on baseline sociodemographic variables, HIV clinical stage, CD4 count, and viral load. Results: Between 26 and 35 wk, haemoglobin, leucocytes, and absolute neutrophil counts decreased in zidovudine-exposed compared to unexposed women ( mean difference [95% CI] - 0.4 [ - 0.5 to - 0.3], - 423 [ - 703 to - 142], - 485 [ - 757 to - 213], respectively). However, between 35 wk and delivery, the haematological parameters increased faster in women exposed to long rather than short durations of zidovudine (0.1 [ 0.0 to 0.1]; 105 [ 18 to 191]; 147 [ 59 to 234], respectively). At delivery, the differences were not statistically significant, except for mean haemoglobin level, which remained slightly lower in the long zidovudine treatment group ( difference: 0.2 g/dl). Zidovudine had no negative impact on the absolute lymphocyte counts. Conclusion: Zidovudine initiated at 28 wk gestation rather than 35 wk had a transient negative impact on the evolution of haematological parameters, which was largely reversed by delivery despite continuation of zidovudine. This result provides reassurance about the safety of early initiation of zidovudine prophylaxis during pregnancy to maximize prevention of perinatal HIV

Haematological Safety of Perinatal Exposure to Zidovudine in Uninfected Infants Born to HIV-1 Infected Women in Thailand

The evolution of hematological parameters in HIV-1-exposed uninfected infants according to various durations of perinatal zidovudine exposure was studied. We used data prospectively collected among 1122 HIV-uninfected formula-fed infants born to HIV-infected mothers who participated in a clinical trial to prevent perinatal transmission in Thailand (PHPT-1). Infants were exposed to different durations of zidovudine both in utero and after birth. Hemoglobin level and leukocyte, absolute neutrophil, and lymphocyte counts were measured at birth and at 6 weeks of age. The association between hematological parameters at birth and the duration of zidovudine exposure in utero was studied using a linear regression model, and changes between birth and 6 weeks of age and the duration of postnatal zidovudine exposure using mixed effects models. At birth, the hemoglobin level was lower in newborns exposed to zidovudine for more than 7.5 weeks in utero (adjusted regression coefficient: −0.6 g/dl; 95% confidence interval: −1.1 to −0.1). Six weeks after birth, the hemoglobin level had decreased faster in infants administered zidovudine for more than 4 weeks (adjusted regression coefficient: −0.1 g/dl; 95% confidence interval: −0.2 to −0.1). The duration of perinatal zidovudine exposure was not associated with the evolution of leukocyte, neutrophil, and lymphocyte counts. Despite the differences in hemoglobin levels, grade 3 or 4 anemia did not significantly differ by maternal or infant zidovudine duration. The clinical impact appeared modest, but longer exposure may warrant close monitoring

Présence par effraction et par intrusion

Dans les arts et la littérature, certaines présences se donnent, avec toute la force de leur évidence, comme déplacées. Les textes réunis dans ce volume s’intéressent à ces formes de présences insolites qui entrent dans un cadre où elles ne sont pas attendues. L’effraction et l’intrusion sont les procédés pour obtenir ces modalités singulières de présence. Dans le fracas ou la délicatesse, l’irrespect des règles et des cadres, le lecteur reconnaîtra l’effraction chargée de violence et évaluera les effets de présence que cette manière de faire permet de révéler. D’une façon moins ostensible, le lecteur pourra également, à son tour, jouer à l’intrus et apprécier de quelles intentions insidieuses ce dernier est animé pour créer des présences illégitimes et parfois incongrues. Car le geste artistique, qu’il émane d’une effraction ou d’une intrusion, est toujours singulier et audacieux. Geste pour le moins iconoclaste, il atteste d’une présence qui, en brisant un ordre institué, dévoile et rappelle l’artificialité de ce dernier

Texte/image — Nouveaux problèmes

Ce volume collectif voudrait témoigner de la variété des questionnements et des approches que suscitent aujourd’hui les études engagées sur le terrain de la confrontation raisonnée des pratiques littéraires (tous genres confondus) et des artefacts artistiques visuels (des réalisations plastiques, figuratives ou non, aux images écrites). Il se propose de rendre compte de la vivacité d’une réflexion qui déplace les frontières notionnelles, redéfinit ses objets et décloisonne ses champs d’investigation et d’application. Le titre « Texte/Image : nouveaux problèmes » avoue cette intention, en même temps qu’il atteste, explicitement, le refus de tout parti pris théorique exclusif. Au dialogue du texte et de l’image correspond ainsi le dialogue ouvert ou le débat contradictoire des chercheurs qui ont participé au colloque de Cerisy-la-Salle et dont les communications recueillies dans le présent volume résument ou développent les propositions

Saliva for molecular detection of SARS‐CoV ‐2 in pre‐school and school‐age children

International audienceSARS-CoV-2 diagnosis is a cornerstone for the management of coronavirus disease 2019 (COVID-19). Numerous studies have assessed saliva performance over nasopharyngeal sampling (NPS), but data in young children are still rare. We explored saliva performance for SARS-CoV-2 detection by RT-PCR according to the time interval from initial symptoms or patient serological status. We collected 509 NPS and saliva paired samples at initial diagnosis from 166 children under 12 years of age (including 57 children under 6), 106 between 12 and 17, and 237 adults. In children under 12, overall detection rate for SARS-CoV-2 was comparable in saliva and NPS, with an overall agreement of 89.8%. Saliva sensitivity was significantly lower than that of NPS (77.1% compared to 95.8%) in pre-school and school-age children but regained 96% when considering seronegative children only. This pattern was also observed to a lesser degree in adolescents but not in adults. Sensitivity of saliva was independent of symptoms, in contrary to NPS, whose sensitivity decreased significantly in asymptomatic subjects. Performance of saliva is excellent in children under 12 at early stages of infection. This reinforces saliva as a collection method for early and unbiased SARS-CoV-2 detection and a less invasive alternative for young children