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The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.
RESUMEN: El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.
Assuntos
Administração Retal , Infecções por HIV , Homossexualidade Masculina , Minorias Sexuais e de Gênero , Humanos , Masculino , Tailândia , Infecções por HIV/prevenção & controle , Malaui , Minorias Sexuais e de Gênero/psicologia , Estados Unidos , Adulto , Feminino , Adulto Jovem , África do Sul , Homossexualidade Masculina/psicologia , Supositórios , Adolescente , Peru , Preferência do Paciente , Comportamento Sexual , Pessoas Transgênero/psicologia , Anti-Infecciosos/administração & dosagem , Placebos/administração & dosagem , Formas de DosagemRESUMO
Objective: Report the clinical case of Gastric Adenomyoma as etiology of pyloric syndrome. Clinical case: We present a 52 years old man who attended the emergency room due pyloric syndrome and who underwent a distal gastrectomy. The pathological report revealed a gastric adenomyoma with ulcerative lesion. Discussion: This pathology is an unusual finding, and the literature describe it with extremely low rate of malignant transformation. Conclusion: Gastric adenomyoma is a infrequent pathology and should be taken into account when endoscopic studies are not enough to determine the etiology of a pyloric syndrome.
Objetivo: Reportar el caso clínico de Adenomioma gástrico como etiología de un síndrome pilórico. Caso Clínico: Presentamos el caso de un varón de 52 años que acudió a emergencia por un síndrome pilórico quien fue sometido a una gastrectomía distal. El reporte de anatomía patológica revelo un Adenomioma gástrico con lesión ulcerativa múltiple. Discusión: Esta patología es un hallazgo inusual, siendo extremadamente baja su tasa de transformación maligna. Conclusiones: El Adenomioma gástrico es una patología infrecuente que debe ser tenida en cuenta cuando los estudios endoscópicos no logran definir la etiología de un síndrome pilórico.
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El páncreas ectópico en vesícula biliar es un hallazgo poco frecuente, con una incidencia menor a 0.5% de los casos descritos en la literatura. Reportamos el caso de una mujer de 26 años que acude a emergencia por dolor abdominal quien fue sometida a una colecistectomía laparoscópica. El reporte anatomopatológico describió tejido pancreático ectópico en la pared de la vesícula biliar. Este hallazgo debe ser evaluado minuciosamente debido a la susceptibilidad del tejido pancreático a patologías como pancreatitis, lesiones quísticas y degeneración maligna, y debe ser considerado en el contexto de un pólipo vesicular asociado a sintomatología digestiva.
Ectopic pancreas is an unusual finding, with an incidence below 0.5% of all reports worldwide. We report a 26 years old woman who went to emergency room with abdominal pain and underwent laparoscopic cholecystectomy. The pathology report described pancreatic ectopic tissue in the wall of the gallbladder. This finding must be thoroughly evaluated because this tissue can suffer diseases like pancreatitis, cystic tumours and malign degeneration, and should be considerated in the context of gallbladder polips with digestive sintomatology.
RESUMO
BACKGROUND: Alcohol use disorders (AUDs) are common in men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence. Oral naltrexone (NTX) is an evidence-based treatment for AUD that has not been assessed in cotreating AUD in MSM/TGW with HIV. SETTING AND DESIGN: A multi-site, randomized, double-blind, placebo-controlled trial among MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru. METHODS: Newly diagnosed MSM/TGW with HIV and AUD were prescribed a single-treatment regimen of EFV/TDF/FTC from 2014 to 2015 and randomized 2:1 to oral NTX (N = 103) or placebo (N = 53) for 24 weeks. The primary and secondary outcomes were proportion achieving viral suppression (VS: HIV-1 RNA < 400 copies/mL) or maximal viral suppression (MVS: HIV-1 RNA < 40 copies/mL) at 24 weeks. RESULTS: There were no significant differences between the arms in VS (81.6% NTX arm vs 75.5% placebo arm; P = 0.37) or MVS (61.2% NTX arm vs 66.0% placebo arm; P = 0.48). Adherence to study medication was low (mean = 34.6%) overall with only 21.4% of participants meeting recommended adherence levels (≥80% daily doses/month). Participants allocated to NTX had significantly lower adherence compared with placebo for both the first and second 12-week study periods, respectively (44.0% vs 35.2%, P = 0.04; 31.4% vs 35.2%, P = 0.03). CONCLUSIONS: Findings are inconclusive regarding the use of NTX for treatment of AUD in MSM/TGW newly diagnosed with HIV. VS and MVS levels were high irrespective of allocation. Adherence to study medication was low, requiring further exploration of strategies to optimize adherence to NTX as AUD treatment.
Assuntos
Alcoolismo , Infecções por HIV , Minorias Sexuais e de Gênero , Pessoas Transgênero , Alcoolismo/complicações , Alcoolismo/tratamento farmacológico , Feminino , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Homossexualidade Masculina , Humanos , Masculino , Naltrexona/uso terapêutico , PeruRESUMO
BACKGROUND: The Antibody-Mediated Prevention trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing monoclonal antibody targeting the CD4-binding site of the HIV envelope protein, prevents sexual transmission of HIV-1. HVTN 704/HPTN 085 enrolled 2701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland, and the United States. METHODS: Participants were recruited and retained through early, extensive community engagement. Eligible participants were randomized 1:1:1 to 10 mg/kg or 30 mg/kg of VRC01 or saline placebo. Visits occurred monthly, with intravenous (IV) infusions every 8 weeks over 2 years, for a total of 10 infusions. Participants were followed for 104 weeks after first infusion. RESULTS: The median HVTN 704/HPTN 085 participant age was 28 years; 99% were assigned male sex; 90% identified as cisgender men, 5% as TG women and the remaining as other genders. Thirty-two percent were White, 15% Black, and 57% Hispanic/Latinx. Twenty-eight percent had a sexually transmitted infection at enrollment. More than 23,000 infusions were administered with no serious IV administration complications. Overall, retention and adherence to the study schedule exceeded 90%, and the dropout rate was below 10% annually (7.3 per 100 person-years) through week 80, the last visit for the primary end point. CONCLUSIONS: HVTN 704/HPTN 085 exceeded accrual and retention expectations. With exceptional safety of IV administration and operational feasibility, it paves the way for future large-scale monoclonal antibody trials for HIV prevention and/or treatment.
Assuntos
Anticorpos Monoclonais/uso terapêutico , Anticorpos Neutralizantes/imunologia , Anticorpos Amplamente Neutralizantes/uso terapêutico , Anticorpos Anti-HIV/uso terapêutico , Infecções por HIV/prevenção & controle , Adolescente , Adulto , Brasil , Estudos de Viabilidade , Feminino , HIV-1/imunologia , Humanos , Masculino , Pessoa de Meia-Idade , Peru , Suíça , Pessoas Transgênero , Estados Unidos , Adulto JovemRESUMO
BACKGROUND: In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits. METHODS: We conducted an open-label randomized clinical study in Lima, Peru among adult men who have sex with men and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within 3 months) HIV infection, who were randomized to start ART immediately versus defer by 24 weeks. We evaluated outcomes by treatment arm and immunologic markers by days since estimated date of detectible infection (EDDI). RESULTS: Of 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate versus deferred arm (83 vs 123/100 person-years, IRR 0.67 (95% confidence interval [CI] .47, .95; Pâ =â .02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (Pâ =â .09 overall), but differences between those initiating ARTâ ≤â 30 days from EDDI (median 1.03, interquartile range [IQR] 0.84, 1.37), and those initiatingâ >â 90 days (0.88, IQR 0.61, 1.11) remained, Pâ =â .02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ARTâ >â 90 days from EDDI versus those starting within 30 or 90 days (both Pâ <â .001). CONCLUSIONS: To our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in World Health Organization recommendations for universal ART. CLINICAL TRIALS REGISTRATION: NCT01815580.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Minorias Sexuais e de Gênero , Adulto , Fármacos Anti-HIV/uso terapêutico , Contagem de Linfócito CD4 , Feminino , Infecções por HIV/tratamento farmacológico , Homossexualidade Masculina , Humanos , Masculino , Peru/epidemiologiaRESUMO
BACKGROUND: We assessed sexual behavior and incidence of sexually transmitted infections (STIs) among men who have sex with men and transgender women participating in Sabes, a study of an expanded treatment as prevention strategy focused on early diagnosis and treatment of HIV infection in Lima, Peru (2013-2017). METHODS: Sabes participants were tested monthly for HIV to identify acute or early infections, and HIV-positive participants were randomized to receive antiretroviral therapy immediately (immediate arm) or after 24 weeks (deferred arm) during a 48-week follow-up period. Sexual behavior was assessed at randomization (baseline) and every 12 weeks thereafter. Participants were tested for urethral and rectal chlamydia and gonorrhea and for syphilis at baseline, 12, 24, and 48 weeks. We describe patterns of sexual behavior during the 48-week follow-up period and compare sexual behavior and STI incidence between study arms. RESULTS: After randomization, 207 HIV-positive participants completed questionnaires and STI testing at 2 or more visits. After HIV diagnosis, participants in both arms reported increases in condom use with main and casual partners and decreased drug and alcohol use before or during anal sex. We observed no between-arm differences in sexual behavior. Deferred arm participants had higher incidence of chlamydia (incidence rate ratio, 2.33; 95% confidence interval, 1.14-4.77) but not gonorrhea or syphilis. CONCLUSIONS: Despite reported increases in condom use, the overall high incidence of STIs reflects some ongoing condomless sex among HIV-positive men who have sex with men and transgender women, highlighting the importance of regular STI screening and counseling to support consistent condom use among HIV-positive individuals at risk for STIs.
Assuntos
Terapia Antirretroviral de Alta Atividade/métodos , Infecções por HIV/tratamento farmacológico , Homossexualidade Masculina/psicologia , Comportamento Sexual/estatística & dados numéricos , Pessoas Transgênero/psicologia , Adulto , Feminino , Infecções por HIV/epidemiologia , Homossexualidade Masculina/estatística & dados numéricos , Humanos , Masculino , Peru/epidemiologia , Parceiros Sexuais , Minorias Sexuais e de Gênero , Infecções Sexualmente Transmissíveis/epidemiologia , Pessoas Transgênero/estatística & dados numéricosRESUMO
Background: Our previous work has demonstrated the benefits of transcutaneous immunization in targeting Langerhans cells and preferentially inducing CD8 T-cell responses. Methods: In this randomized phase Ib clinical trial including 20 HIV uninfected volunteers, we compared the safety and immunogenicity of the MVA recombinant vaccine expressing HIV-B antigen (MVA-B) by transcutaneous and intramuscular routes. We hypothesized that the quality of innate and adaptive immunity differs according to the route of immunization and explored the quality of the vector vaccine-induced immune responses. We also investigated the early blood transcriptome and serum cytokine levels to identify innate events correlated with the strength and quality of adaptive immunity. Results: We demonstrate that MVA-B vaccine is safe by both routes, but that the quality and intensity of both innate and adaptive immunity differ significantly. Transcutaneous vaccination promoted CD8 responses in the absence of antibodies and slightly affected gene expression, involving mainly genes associated with metabolic pathways. Intramuscular vaccination, on the other hand, drove robust changes in the expression of genes involved in IL-6 and interferon signalling pathways, mainly those associated with humoral responses, and also some levels of CD8 response. Conclusion: Thus, vaccine delivery route perturbs early innate responses that shape the quality of adaptive immunity. Clinical Trial Registration: http://ClinicalTrials.gov, identifier PER-073-13.
Assuntos
Vacinas contra a AIDS/administração & dosagem , Vacinas contra a AIDS/imunologia , Vacinas Virais/administração & dosagem , Vacinas Virais/imunologia , Vacinas contra a AIDS/efeitos adversos , Administração Cutânea , Anticorpos Antivirais/imunologia , Anticorpos Anti-HIV/imunologia , HIV-1 , Humanos , Imunidade Celular/imunologia , Injeções Intramusculares , Vacinação/métodos , Vacinas de DNA , Vacinas Sintéticas/imunologia , Vacinas Virais/efeitos adversosRESUMO
HIV disproportionately affects men who have sex with men (MSM) and transgender women (TW). These populations use alcohol more heavily than the general population, and alcohol use disorders (AUDs) are more prevalent among them. Naltrexone (NTX) has documented efficacy and safety as a medication-assisted therapy for AUD. Its use has not been well-examined in persons with HIV (PWH) newly initiating antiretroviral therapy (ART) where the possibility of hepatotoxicity may be increased when initating multiple new medications. This study assessed the safety of oral NTX treatment (50 mg daily) initiated concomitantly with antiretroviral therapy (ART) in a double-blind randomized placebo-controlled trial of NTX in MSM/TW in Lima, Peru among MSM and TW with AUD (AUDIT score ≥ 8). We analyzed adverse event data from ART-naïve participants (N = 155) who were randomized (2:1) to initiate ART plus NTX (N = 103) or ART plus placebo (N = 52). Participants were monitored for 24 weeks while taking ART plus NTX/placebo, followed by 24 weeks receiving ART alone. Over 48 weeks, 135 grade 2 or 3 adverse events were reported, resulting in 1.3 clinical adverse events per participant equally represented in both treatment and placebo arms. Two serious adverse events occurred among two participants receiving NTX; neither was attributed to the study medication. No significant differences were found in the proportion of subjects reporting any adverse events between treatment arms across all time-points. These results suggest NTX is safe in MSM/TW PWH with AUD newly initiating ART, as no excess of clinical adverse events or transaminase elevation was associated with NTX use.