Centers For Disease Control Classification Research Articles

Duramesh registry study: short-term outcomes using mesh suture for abdominal wall closure.

Sutures are flexible linear elements that join tissue and maintain their hold with a surgeon-created knot. Tension at the suture/tissue interface can cut the very tissues that sutures are designed to hold, leading to dehiscence and incisional hernia formation. A new suture design (Duramesh, Mesh Suture Inc., Chicago, IL) was approved for marketing by the United States Food and Drug Administration in September 2022. The multiple filaments of the mesh suture are designed to diffuse tension at the suture/tissue interface thereby limiting pull-through. The macroporosity and hollow core of the mesh suture encourage fibrovascular incorporation for a durable repair. We created the first registry and clinical report of patients undergoing mesh suture implantation to assess its real-world effectiveness. A patient registry was created based on institutional implant logs from January to August 2023 at an integrated health-care system. Operative reports were reviewed by the study team to verify use of "Duramesh" by dictation. Retrospective chart review was conducted to evaluate patient and surgical characteristics, follow-up, and short-term outcomes of interest. Results were analyzed using descriptive statistics and Chi-squared analysis with Microsoft Excel and GraphPad Prism. Three hundred seventy-nine separate implantations by 56 surgeons across 12 (sub) specialties at a university hospital and two community hospitals were performed. Mesh suture was used for treatment of the abdominal wall in 314 cases. Follow-up averaged 80.8 ± 52.4 days. The most common abdominal wall indications were ventral hernia repair (N = 97), fascial closure (N = 93), abdominal donor site closure from autologous breast reconstruction (N = 51), and umbilical hernia repair (N = 41). Mesh suture was used in all Centers for Disease Control (CDC) wound classifications, including 92 CDC class 2 or 3 abdominal operations. There were 19 surgical site infections (6.1%) and 37 surgical site events (11.8%). Short-term registry data demonstrates the wide diversity of surgical disciplines and scenarios in which mesh suture has been used to date. The early adoption of mesh suture into practice highlights that consequences of suture pull-through influence operative decision making. As this is the first interim report of the Duramesh mesh suture registry, follow-up is too short for characterization of long-term durability of abdominal wall closures.

Ventral Hernia Reconstruction With GORE ENFORM Biomaterial

Introduction:Ventral hernia repair (VHR) is one of the most common surgeries performed in the United States. Degradable mesh is the recommended choice for patients presenting with high-risk co-morbidities or increased risk for infection. GORE® ENFORM BiomaterialTM is a biosynthetic degradable mesh that has recently been approved for use in ventral hernia reconstruction with no reports of its clinical outcomes. Methods: This study was a single surgeon case series. Patients were included in the study if they underwent VHR with GORE® ENFORM BiomaterialTM. The decision to use GORE® ENFORM BiomaterialTM was the senior surgeon’s decision based on the patient's center for disease control classification. Patient comorbidities, hernia characteristics, postoperative hernia recurrence, and surgical site occurrences (SSOs) were collected at in-patient follow-up appointments and chart review. Patients were asked to complete preoperative and postoperative patient-reported outcomes (PROs) using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity short form 3a and the hernia-specific quality of life (HerQLes) survey. Results: A total of 15 patients were included in this study. The average length of follow-up was 315 days. Postoperatively, 26.7% of patients had an SSO with 4 surgical site infections. Two patients required an operative washout with mesh removal. One patient experienced hernia recurrence. Eight of the 15 patients completed preoperative and postoperative PROs. Conclusion: This is the first clinical study to report the outcomes of ventral hernia repair using ENFORM mesh. These results show that Enform mesh is an option to consider in complex ventral hernia reconstruction.

Single-stage abdominal wall reconstruction in contaminated and dirty wounds is safe: a single center experience.

The proper approach to repair of complex abdominal wall hernia in contaminated and dirty surgical fields is unknown. Identification of a surgical approach limiting the number of operative procedures, post-operative complications, and financial burden is needed. We hypothesized that single-stage abdominal wall reconstruction using poly-4-hydroxybutyrate resorbable mesh would result in low incidence of post-operative surgical site occurrence and a low incidence of hernia recurrence in Centers for Disease Control class III and IV wounds. We conducted a single institution, retrospective cohort study of consecutive patients, age greater than 18years old, that underwent abdominal wall reconstruction complicated by presence of Centers for Disease Control class III and IV wounds between January 2014 and March 2019. Primary outcomes assessed were surgical site occurrence, hernia recurrence, and mesh-related adverse events. Thirty-four patients that underwent single-stage abdominal wall reconstruction utilizing poly-4-hydroxybutyrate mesh with contaminated (n = 12) and dirty/infected wounds (n = 22) were identified. Patients mean age was 64years, and body mass index was 31kg/m2. Mean follow-up was 37months, range of 21-60. Concurrent procedures included fistula takedown (n = 9), infected mesh removal (n = 6), and parastomal hernia repair (n = 6). Mean defect size was 150.7 cm2. Surgical site occurrence rate was 12%, with 1 superficial and 2 deep surgical site infections. Midline hernia recurrence rate was 0, there were two parastomal hernia recurrences, for an overall hernia recurrence rate of 6%. No mesh-related adverse events occurred. This study suggests that over a 3-year follow-up period single-stage complex abdominal wall reconstruction with poly-4-hydroxybutyrate is safe and durable. Single-stage complex abdominal wall reconstruction with poly-4-hydroxybutyrate mesh in the setting of Centers for Disease Control class III and IV wounds is a realistic option with acceptable outcomes.

Outcomes of biosynthetic absorbable mesh use in high risk CDC Class I ventral hernia repair: a single surgeon series.

Biosynthetic absorbable meshes have emerged as suitable alternatives to permanentsynthetic and biologic meshes in complex ventral hernia repair in contaminated wounds. Evidence regarding the use of these products in clean wounds is currently scant. This paper presents a large single surgeon series using GORE®BIO-A® (W.L. Gore & Associates, Newark, DE) (Bio-A) tissue reinforcement in high risk patients with predominantly CDC Class I wounds. Retrospective review of a prospectively maintained database of consecutive patients who underwent open ventral hernia repair with biosynthetic absorbable mesh was conducted. Ventral Hernia Working Group (VHWG) classification based on patient demographics and Centers for Disease Control (CDC) wound type were collected prospectively. All patients were followed up for a minimum of 12months post-operatively. 155 patients were included with a mean post-operative follow up of 29months (range 12-62months). Mean age was 61.8years with an average BMI of 33.5kg/m2. 147 patients (94.9%) were classified as VHWG 2 or 3 based on comorbidities or surgical field contamination. 69% (n = 107) of wounds were designated CDC Class I. Mean hernia size was 119.7cm2 with recurrent defects comprising 32.3% (n = 50). Retrorectus mesh repair was achievedin84.5% of patients (n =131). Post-operative wound events occurred in 19.3%. No mesh was explanted. Hernia recurrence rate was 9.0% with a mean time to recurrence of 14months. There was no significant difference in recurrence rates between clean and contaminated wounds. This study supports the use of Bio-A in high risk ventral hernias, demonstrating a safe and durable repair across all wound classes. Ongoing follow-up continues to monitor for late complications and recurrence.

Caregivers' perceptions of the relationship among weight, health status, and asthma in their children.

Asthma and obesity are the two most common childhood illnesses and are physiologically interrelated. Few studies have assessed parental perceptions and beliefs about this relationship to better target education and therapy. This study aimed to determine caregiver beliefs and perceptions regarding weight, health status, and asthma diagnoses. Data from a survey of caregivers to children aged 4-11years are merged with corresponding anthropometric and medical data from the electronic medical record. Caregivers of children with asthma completed a supplemental questionnaire. Univariable and multivariable logistic regressions were used to evaluate associations between perception of health problem, asthma, and weight status. Increased weight status was ≥ 85th body mass index percentile per Centers for Disease Control classifications. Compared to caregivers of healthy children and those of children with healthy weight and asthma, caregivers of dual diagnosis children were more likely to identify weight as a health problem (OR = 3.89, 95% confidence interval [1.48, 10.21]). Nevertheless, only 31% of caregivers of children with dual diagnosis believed weight contributed to the severity of their child's asthma. Less than one third of caregivers of dual diagnosis children believed that these diagnoses are interrelated. Addressing this gap in understanding is a critical next step to developing family-centered interventions.

17191 Antibiotic prophylaxis in dermatologic surgery: The data behind the recommendations

Nearly all dermatologic surgeries fall under the Center for Disease Control Classification as class 1 or class 2, with infection rates involving 0%-5% and 5%-10% respectively. Dermatologists often prescribe peri-operative antibiotics prior to, or immediately after a surgical procedure when there is risk for surgical site infection, prosthetic joint infection, or infective endocarditis. These prescribing habits may be due to numerous guideline and review articles, without a concise reference to the data upon which those guidelines are advised.

Outcomes of Open Complex Ventral Hernia Repairs With Retromuscular Placement of Poly-4-Hydroxybutyrate Bioabsorbable Mesh.

Purpose. Optimal technique and mesh selection still debated for complex ventral hernias. Limited data exists on bioabsorbable meshes in high-risk patients. We evaluated our experience. Methods. Retrospective review was conducted following institutional review board approval for ventral hernia repairs using a single bioabsorbable mesh between February 2014 and November 2017. Patient and hernia details characterized. Outcomes evaluated. Results. 20 ventral hernia repairs identified, 10 males, 10 females. Mean body mass index was 35 ± 7.4 kg/m2, and mean age 47 ± 13 years. Comorbid conditions were diabetes 35% and hypertension 40%. Fifty-five percent had American Society of Anesthesiologist scores of 3. Hernia Characteristics: Ventral Hernia Working Group Grade 3 hernias were 80%, and remainder grade 2. Forty percent of hernias were Centers for Disease Control class III, and remainder were class I and II. The mean defect size was 533 cm2 ± 500. Repair for prior open abdomens was 45%, recurrent hernias 20%, incisional 15%, incarcerated 10%, incisional with parastomal 5%, and primary ventral 5%. Concomitant bowel procedures in 8, (40%). All cases had retromuscular mesh placement (transversus abdominus release 65%, Rives-Stoppa 35%). Surgical site occurrences were 20% (surgical site infection 10%, seroma 10%). Overall hospital stay 5 ± 3 days. Ileus occurred in 20%. One postoperative death due to fatal arrhythmia. There were no recurrences with mean follow-up 21.1 months. Conclusions. Complex hernia repairs using bioabsorbable mesh were conducted in a small cohort of high-risk patients. These data demonstrate good outcomes with limited morbidity and mortality. There were no recurrences.

Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study.

Objective:The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months.Background:CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates.Methods:Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm2 had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests.Results:Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05).Conclusions:In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

HIV Drug Therapy in the Americas 8–10 May 2014, Rio de Janeiro, Brazil

HIV Drug Therapy in the Americas 8–10 May 2014, Rio de Janeiro, Brazil

Adherence in HIV‐positive patients treated with single‐tablet regimens and multi‐pill regimens: findings from the COMPACT study

The use of Combination AntiRetroviral Therapy (cART) has decreased the morbidity and mortality of patients infected with HIV. However, adherence to cART remains crucial to prevent virological failure and disease progression. The aim of this study was to assess adherence to treatment among patients treated with Single Tablet Regimen (STR) or with multi-pill regimens based on Protease Inhibitors (PI), Non-Nucleoside Reverse-Transcriptase Inhibitors (NNRTI), or raltegravir (RAL). An observational retrospective cohort analysis based on administrative and clinical databases was conducted at the National Institute for Infectious Diseases (Rome, Italy). HIV-positive patients treated with a cART between Jan 1st, 2008–Dec 31st, 2010 were included. Patients were followed-up for one year since the first prescription during the inclusion period or up to death or switch of at least one drug of the regimen. Adherence and selective non-adherence (days without backbone or 3rd drug) were calculated using pharmacy refill compliance [1]. cART regimens were classified based on number of daily pills (STR vs multi-pill regimen) and on type of third drug. Viral Load (VL) and CD4 cell counts at the end of the follow-up were evaluated. A total of 1,604 patients were analyzed, 70.0% male, age 45.0±8.7, 14.3% newly treated. Patients on STR were 159 (9.9%), PI 878 (54.7%), NNRTI 523 (32.6%), RAL 44 (2.7%). Presence of at least one AIDS-defining conditions (according to Centers for Disease Control classification) was 30% in the STR group, 34% PI, 26% NNRTI, 34% RAL (p=n.s.). Adherence was 80.4±14.7% for STR, 71.8±21.8% PI, 77.1±20.3% NNRTI, 74.0±22.4% RAL. Selective non-adherence was 5.5% (18 days) PI, 2.8% (8 days) NNRTI, 12.5% (43 days) RAL (Figure 1). At the end of the follow-up, VL/CD4 values were available among 709 patients (44%); CD4 count >500 cell/mm3 was observed among 61% of patients on STR, 44% PI, 48% NNRTI, 42% RAL and VL < 50 copies/ml was observed among 96% of patients on STR, 78% PI, 88% NNRTI, 87% RAL. Interruptions in cART refill remain a relevant problem across all cART regimens. Patients on STR displayed a higher adherence rate compared to multi-pill regimes (PI, NNRTI, and RAL), primarily due to lack of selective non-adherence. Patients on STR experienced also higher rates of VL < 50 and CD4 > 500. The use of an STR regimen appears an effective therapeutic option to avoid selective non-adherence and, consequently, to prevent virological failure and disease progression.Figure 1Non-adherence to cART regimens.

Long‐term follow‐up of nevirapine‐treated patients in a single‐centre cohort

We reviewed the safety and efficacy of nevirapine (NVP)-based therapy in all patients initiating NVP-containing combined antiretroviral therapy [cART (>or=3 drugs)] in our clinic since 1994. Patient characteristics and laboratory values from the start of the NVP-based cART regimen to the last available follow-up or to NVP discontinuation were retrieved from an observational database. Five hundred and seventy-three patients were treated with NVP-based cART for a median of 18.4 (range 0.1-128.8) months. The 1-year cumulative estimated probability of discontinuing NVP-containing regimens for toxicity was 0.203. Only 1.9% developed a grade 3 alanine aminotransferase (ALT) elevation. Significant increases in high-density lipoprotein cholesterol were observed up to month 12 except in treatment-naïve patients, where the increase was limited to 3 months. Discontinuation because of cutaneous reaction was predicted independently by female gender [Hazard Ratio (HR) 3.21, P<0.001] and Centers for Disease Control class C (HR 0.50, P=0.012). Discontinuation because of liver toxicity was predicted independently by anti-hepatitis C virus positivity (HR 3.84, P<0.001). In patients starting NVP-containing cART with undetectable viral loads, the 5-year estimated probability of viral load >400 HIV-1 RNA copies/mL was 0.34. Long-term follow-up with an NVP-containing cART showed a low rate of discontinuation caused by liver toxicity and the maintenance of virological suppression in patients switched with undetectable viral loads.

Evidence for circulating activated cytotoxic T cells in HIV-infected subjects before the onset of opportunistic infections

The activity of both cytotoxic T lymphocyte (CTL) and natural killer (NK) cells were measured cross-sectionally in 43 subjects seropositive for HIV, in 27 HIV- blood donors and in 24 HIV- persons from the Outpatients Clinic for sexually transmitted diseases. CTL activity was evaluated using the HL-60 cells coated with OKT3 as the targets and freshly separated peripheral blood lymphocytes as the effectors. In 20 out of 43 HIV+ subjects, CTL activity was significantly enhanced in comparison to the HIV- subjects. This lytic activity correlated positively with the percentages of CD3+ HLA-DR+, of CD8+ CR3- and of CD57+ CD16- lymphocytes, and was greatly reduced after elimination of CD8+, of HLA-DR+ or of CD57+ cells. The median CTL activity seemed to increase from CDC group II to CDC group IV (Centers for Disease Control classification), but to return back to control levels in those patients with a history of opportunistic infections. NK function in HIV+ subjects was not significantly different from that in the blood donors. In seropositive patients, NK activity correlated positively with the percentages of both CD16+ CD57+ and of CD8+ CR3+ cells and was strongly diminished after elimination of CD16+ or of CD57+ cells. There was no significant change in NK function according to the clinical stage. The data show that circulating CD8+ HLA-DR+ CD57+ T cells in HIV+ subjects are activated cytotoxic T cells and point to progressive (over) activation of this T cell compartment until the onset of opportunistic infections.

Impact on Weight and Height With the Use of HAART in HIV-Infected Children

There are few data on long-term effects of highly active antiretroviral therapy (HAART) on weight and height in HIV-infected children. Our objective was to assess the effect of HAART on the weight and height of HIV-infected children over time in the Madrid cohort, and analyze possible factors associated with the effect. This was a retrospective study of HIV-infected children starting HAART in 1997 or later. Serial measurements of weight, height and body mass index (BMI) were performed and converted to z-scores using the Spanish revised reference data. Changes from baseline in weight, height and BMI at 12, 24, 36, 48 and 60 months were determined. Associations of z-scores at the last visit with immunologic (CD4% above 25%) and virologic responses (more than 50% of samples below 400 copies/mL), CDC (Centers for Disease Control) clinical category, and the presence and type of lipodystrophy (lipoatrophy or lipohypertrophy) were evaluated. Twelve hundred and twelve children, 97% of them vertically-infected, received HAART starting in 1997 for a median of 71 months (4-102 months). Median age at initiation of HAART was 6 years (1 month-18 years). Thirty-nine percentage were antiretroviral naive and 61% had received NRTI therapy previously. Thirty-two percentage and 53% had CDC class C and immunologic class 3, respectively. At the final evaluation, 24% of children remained on their first combination therapy, 39% on the second and 37% had received at least 3 different HAART regimens. Fifty-one percentage were classified as virologic responders. Thirty-nine percentage of children in this study were diagnosed with lipodystrophy. At baseline, median z-score for weight, height and BMI were -0.45, -0.60 and -0.33, respectively. HAART was associated with significant increases in z-scores of weight and height but not BMI at the different time-points analyzed. Virologic nonresponders had significantly lower z-scores for weight and height but not for BMI. CDC class C was associated with lower z-scores for height. No differences in final measurements were observed for baseline CD4, immunologic response or lipoatrophy. Children with lipohypertophy had a significantly higher BMI at the last visit. HIV-infected children experienced a continued catch-up in weight and height 5 years after starting HAART. Virologic control is related to sustained growth.

Características maternas en una cohorte de gestantes con infección por el VIH-1

The main strategies to avoid the vertical transmission of human immunodeficiency virus (HIV-1) is antiretroviral treatment during pregnancy, delivery and to the newborn. Nevertheless, there are scant data about safety of antiretroviral drugs and follow-up studies with a large number of pregnant women are needed. The aims of our study are: to assess toxicity associated with antiretroviral treatment, to determine vertical transmission, and to define epidemiological trends within this population. In this paper we present maternal characteristics of the cohort. Observational, multicentric, collaborative study about an HIV-1 infected pregnant women cohort and their offspring (666 and 686 cases, respectively) who were born during the study period (from January or May 2000 to 31st december 2003). Most pregnant women were infected by heterosexual transmission (54%). 71% women were included in stage A of the Centers for Disease Control classification of HIV infection and 74% women have received high activity antiretroviral treatment during pregnancy. Prevalence of adverse effects treatment-related was 7%, mainly anaemia related to treatment with zidovudine. We found 6 cases of vertical transmission among 686 newborns (0.8%; 95% confidence interval, 0.3-1.8). Most patients received highly active antiretroviral treatment, with a good tolerance and a low prevalence of adverse effects related to the treatment. Vertical transmission rate is very low, not higher than 1%. Apart from this, is necessary to pay attention to other phenomena like hepatitis C virus coinfection, other potentially serious adverse effects like hepatotoxicity and pregnancy-related pathologies more frequent in this population, like prematurity and gestational diabetes.

Non-condylomatous, perianal disease in homosexual men.

This retrospective study details the findings and outcome in 34 homosexual men, out of a total of 177 patients, who underwent surgery for non-condylomatous perianal disease over a 2-year period. Of 34 homosexuals 20 presented with anorectal sepsis compared with 11 of 79 heterosexual male patients (X2 = 24.07, P less than 0.001). Lesions included chronic intersphincteric abscess (eight patients), anal fistula (seven patients) and chronic intersphincteric abscess and fistula (five patients). Anal fissure occurred in 15 patients, anal ulcer in three, skin tags in six, haemorrhoids in two and Kaposi's sarcoma in one. Eight patients were human immunodeficiency virus (HIV) antibody negative, four were asymptomatic HIV antibody positive, 12 had symptomatic HIV infection using the Centers for Disease Control classification and in ten patients HIV status was unknown. Irrespective of the type of surgery performed, healing occurred within 6 weeks of operation in all HIV antibody negative patients, all asymptomatic HIV antibody positive and in only one of nine patients with symptomatic HIV infection. Eight of nine patients with symptomatic HIV infection failed to heal by this time (X2 = 8.98, P less than 0.05). These findings suggest that the prevalence of anorectal sepsis in homosexual men is high and that symptomatic HIV infection is an important determinant of progress after surgery.

Utility of Interrupting Antiretroviral Treatment Before HIV Drug Resistance Testing in Patients With Persistently Detectable Low-Level Viremia

Utility of Interrupting Antiretroviral Treatment Before HIV Drug Resistance Testing in Patients With Persistently Detectable Low-Level Viremia

Oxidative stress levels are raised in chronic fatigue syndrome and are associated with clinical symptoms

The aetiology of chronic fatigue syndrome (CFS) is unknown; however, recent evidence suggests excessive free radical (FR) generation may be involved. This study investigated for the first time levels of 8-iso-prostaglandin-F 2α-isoprostanes alongside other plasma markers of oxidative stress in CFS patients and control subjects. Forty-seven patients (18 males, 29 females, mean age 48 [19–63] years) who fulfilled the Centres for Disease Control classification for CFS and 34 healthy volunteers (13 males, 21 females, 46 [19–63] years) were enrolled in the study. The CFS patients were divided into two groups; one group had previously defined cardiovascular (CV) risk factors of obesity and hypertension (group 1) and the second were normotensive and nonobese (group 2). Patients had significantly increased levels of isoprostanes (group 1, P = 0.007; group 2, P = 0.03, unpaired t test compared to controls) and oxidised low-density lipoproteins (group 2, P = 0.02) indicative of a FR attack on lipids. CFS patients also had significantly lower high-density lipoproteins (group 1, P = 0.011; group 2, P = 0.005). CFS symptoms correlated with isoprostane levels, but only in group 2 low CV risk CFS patients (isoprostanes correlated with; total symptom score P = 0.005; joint pain P = 0.002; postexertional malaise P = 0.027, Pearson). This is the first time that raised levels of the gold standard measure of in vivo oxidative stress (isoprostanes) and their association with CFS symptoms have been reported.

Lack of association between nutritional status and change in clinical category among HIV-infected children in Brazil

Malnutrition is common among HIV-infected children. Our objective was to study the occurrence of malnutrition and its relationship with changes in clinical category among HIV-infected children. Longitudinal study, at the Pediatrics Department and Pediatrics Investigation Center (CIPED), Faculdade de Ciências Médicas da Universidade Estadual de Campinas (Unicamp). We reviewed the hospital records of 127 vertically HIV-infected children. Anthropometric measurements were obtained at the beginning of follow-up, at clinical category change and five months later. These were converted to z-scores of weight/age, height/age and weight/height. Data were presented as means, standard deviations, frequency counts and percentages. The Wilcoxon and Kruskal-Wallis tests and odds ratios were used in the analysis. We found that 51 (40.2%) were undernourished and 40 (31.5%) were stunted, with higher risk of being included in clinical category C. There was an association between nutritional condition and the clinical categories of the Centers for Disease Control classification (1994), and with age at symptom onset (except for height z-score). During follow-up, 36 patients (28.4%) changed their clinical category, which occurred early among the undernourished patients. The group that changed its clinical category maintained the same z-score distribution for weight, height and weight/height throughout follow-up. Aids manifestation severity was associated with nutritional status and with age at symptom onset, but change in clinical category was not followed by worsening of nutritional status.

New scheme of oral rapid desensitization to TMP-SMX in HIV-infected patients. Efficacy and safety

Rationale Trimethoprim Sulfamethoxazole (TMP-SMX) represents the first-line treatment to HIV-seropositive patients for prophylaxis or treatment of pneumonia for Pneumocistis Carini, but is commonly discontinued because of hypersensitivity reactions. Different studies have tried long and short desensitization schemes, with a efficacy from 30 to 100%. In our country TMP-SMX represents the more accessible therapy for the HIV infected patient. The objective of our study was to evaluate safety and efficiency of a protocol of rapid oral desensitization to TMP-SMX (5 hours) in previously hypersensitive patients. Methods The design of the study was prospective, open and with a 6 months length. Informed Consent was signed by all the patients. Sixteen patients were desensitized increasing concentrations every 15 minutes until 320 mgs of TMP, with a challenge 48 later with the same dosage. Results Eighty one per cent of the patients were AIDS cases according CDC (Center for Disease Control) classification system from 1993. None of the patients had alterations on hepatic enzymes, hematologic parameters, urea and creatinine. Seventy per cent did not present reaction of hypersensitivity even after the challenge, and after taking TMP on next times and 5% diminished the severity of symptoms, being statistically significant with p<0,05 (0,0067 and 0,0030 according to Test Wilcoxon and Mann-Whitney respectively). Desensitization failed in 25%. No life-threatening reactions occurred nor statistically significant alterations on the laboratory parameters after the desensitization. Conclusions The protocol of desensitization rapid is a simple, safe and effective method since it allows the administration of TMP-SMX in 75% of desensitized patients.

The NEAT Study: A 48-Week Open-Label Study to Compare the Antiviral Efficacy and Safety of GW433908 Versus Nelfinavir in Antiretroviral Therapy???Naive HIV-1-Infected Patients

To compare the efficacy, durability, and tolerability of GW433908 (908), 1400 mg twice-daily (BID), with nelfinavir (NFV), 1250 mg BID. This was an international, multicenter, randomized, open-label study (NEAT) in antiretroviral therapy (ART)-naive HIV-infected adults with plasma HIV-1 RNA (vRNA) at screening > or =5000 copies/mL (c/mL). Patients were randomly assigned to 908 or NFV (2:1) for a minimum of 48 weeks, with a background of abacavir (ABC) and lamivudine (3TC). A total of 166 patients received randomized treatment with 908 BID and 83 received NFV BID. The population was diverse with regard to race and gender (76% Hispanics and blacks, 31% female) and had advanced HIV disease at screening (45% had vRNA >100,000 c/mL, 48% had CD4 cell counts <200 cells/mm3, 20% had a history of Centers for Disease Control class C events). After 48 weeks of study by an intention-to-treat rebound or discontinuation = failure analysis, a greater proportion of patients in the 908 BID group (66%) than the NFV BID group (51%) achieved vRNA <400 c/mL. Furthermore, more patients with screening vRNA >100,000 c/mL (67 vs. 35%) or CD4 <50 cells/mm3 (48 vs. 24%) achieved undetectable viral loads taking 908 BID compared with NFV BID, respectively. Favorable immunologic responses were observed for both groups. Diarrhea, which was more common in the NFV BID group (18 vs. 5%), was the only drug-related grade 2-4 adverse event with a significant difference (P = 0.002) in incidence between groups. Administration of 908 BID resulted in a potent and sustained antiretroviral response, notably in ART-naive patients with advanced HIV disease. GW433908 was generally well tolerated and provides a convenient dosing option without food or fluid restrictions.