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1.
HIV Med ; 20(5): 337-343, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30873741

RESUMEN

OBJECTIVES: The aim of the study was to evaluate darunavir and cobicistat pharmacokinetics in pregnant women with HIV-1 infection. METHODS: This phase 3b, open-label study enrolled HIV-1-infected pregnant women (18-26 weeks of gestation) receiving combination antiretroviral therapy with once-daily darunavir/cobicistat 800/150 mg. The plasma pharmacokinetics of darunavir (total and unbound) and cobicistat were assessed over 24 h during the second and third trimesters (24-28 and 34-38 weeks of gestation, respectively) and 6-12 weeks postpartum. Pharmacokinetic parameters [area under the plasma concentration-time curve over 24 h (AUC24 h ), maximum plasma concentration (Cmax ) and minimum plasma concentration (Cmin )] were derived using noncompartmental analysis and compared using linear mixed effects modelling (pregnancy versus postpartum). Antiviral activity and safety were evaluated. RESULTS: Seven women were enrolled in the study; six completed it. Total darunavir exposure was lower during pregnancy than postpartum (AUC24 h , 50-56% lower; Cmax , 37-49% lower; Cmin , 89-92% lower); unbound darunavir exposure was also reduced (AUC24 h , 40-45% lower; Cmax , 32-41% lower; Cmin , 88-92% lower). Cobicistat exposure was also lower during pregnancy than postpartum (AUC24 h , 49-63% lower; Cmax , 27-50% lower; Cmin , 83% lower). At study completion, five of six (83%) women were virologically suppressed (HIV-1 RNA < 50 copies/mL). There was one virological failure (the patient was nonadherent; no emerging genotypic resistance was observed and susceptibility to antiretrovirals was maintained). No mother-to-child transmission was detected among six infants born to the six women who completed the study. Overall, darunavir/cobicistat was well tolerated in women and infants. CONCLUSIONS: In view of markedly reduced darunavir and cobicistat exposures during pregnancy, this combination is not recommended in HIV-1-infected pregnant women.


Asunto(s)
Cobicistat/farmacocinética , Darunavir/farmacocinética , Infecciones por VIH/tratamiento farmacológico , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Adulto , Cobicistat/administración & dosificación , Darunavir/administración & dosificación , Quimioterapia Combinada , Femenino , Edad Gestacional , Humanos , Recién Nacido , Transmisión Vertical de Enfermedad Infecciosa/estadística & datos numéricos , Edad Materna , Periodo Posparto/sangre , Embarazo , Segundo Trimestre del Embarazo/sangre , Resultado del Tratamiento
4.
Science ; 360(6385): p. 158-159, 2018.
Artículo en Inglés | Sec. Est. Saúde SP, SESSP-IBPROD, Sec. Est. Saúde SP | ID: but-ib15305
5.
Papillomavirus Res ; 4: 39-44, 2017 12.
Artículo en Inglés | MEDLINE | ID: mdl-29179868

RESUMEN

OBJECTIVES: Puerto Rico (PR), is the fifth highest jurisdiction of the United States of America (US) with respect to HIV prevalence and the leading in cervical cancer incidence. This cross-sectional study describes the prevalence and correlates of cervical HPV infection among a clinic-based sample of 302 women living with HIV/AIDS in PR. METHODS: Data collection included questionnaires, blood and cervical samples. Multivariable logistic regression models were used to estimate the magnitude of association (adjusted Prevalence odds ratio [aPOR]) between HPV cervical infection and other covariates. RESULTS: Mean age of participants was 40.3 years (± 10.3SD). The prevalence of HPV infection was 50.3%; 41.1% for low-risk types and 29.5% for high-risk types. Having ≥ 10 lifetime sexual partners (aPOR = 2.10, 95% CI:1.02-4.29), an abnormal Pap (aPOR = 3.58, 95% CI:1.93-6.62), active genital warts (aPOR = 3.45, 95% CI:1.60-7.42), and CD4 counts ≤ 200 (aPOR = 4.24, 95% CI: 1.67-10.78) were positively associated with any cervical HPV infection. Similar results were observed for HR HPV infection. CONCLUSIONS: A high burden of HPV co-infection exists among women living with HIV/AIDS in this population. Given the high incidence of HIV in PR and the higher risk of cervical cancer among women living with HIV/AIDS, HPV vaccination should be promoted in this population.


Asunto(s)
Cuello del Útero/virología , Coinfección/epidemiología , Infecciones por VIH/epidemiología , Hispánicos o Latinos , Infecciones por Papillomavirus/etnología , Infecciones por Papillomavirus/epidemiología , Adulto , Coinfección/virología , Condiloma Acuminado/epidemiología , Condiloma Acuminado/etiología , Condiloma Acuminado/virología , Costo de Enfermedad , Estudios Transversales , ADN Viral , Femenino , Infecciones por VIH/complicaciones , Infecciones por VIH/virología , Humanos , Modelos Logísticos , Oportunidad Relativa , Papillomaviridae/genética , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/virología , Prevalencia , Puerto Rico/epidemiología , Factores de Riesgo , Parejas Sexuales , Encuestas y Cuestionarios , Neoplasias del Cuello Uterino/epidemiología , Neoplasias del Cuello Uterino/etiología , Neoplasias del Cuello Uterino/virología
6.
HIV Med ; 17(9): 643-52, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-27187894

RESUMEN

OBJECTIVES: HIV antiretroviral therapy during pregnancy is recommended to reduce the risk of mother-to-child transmission and for maternal care. Physiological changes during pregnancy can affect pharmacokinetics. The impact of pregnancy was evaluated for once-daily (qd) darunavir/ritonavir. METHODS: HIV-1-infected pregnant women on an antiretroviral regimen that includes darunavir were enrolled in the study and further treated with darunavir/ritonavir 800/100 mg qd. Plasma concentrations were assessed over 24 h during the second and third trimesters and postpartum using a validated high-performance liquid chromatography tandem mass spectrometry assay for total darunavir and ritonavir, and using (14) C-darunavir-fortified plasma for unbound darunavir. Pharmacokinetic parameters were derived using noncompartmental analysis. Safety and antiviral response were assessed at all visits. RESULTS: Data were available for 16 women. The area under the plasma concentration-time curve from 0 to 24 h (AUC24h ) for total darunavir was 34-35% lower during pregnancy vs. postpartum. Unbound darunavir AUC24h was 20-24% lower during pregnancy vs. postpartum. The minimum plasma concentration of total and unbound darunavir was 32-50% and 13-38% lower, respectively, during pregnancy vs. postpartum. The antiviral response (< 50 HIV-1 RNA copies/mL) was 59% at baseline and increased to 87-100% during the trial; the CD4 count increased over time. One serious adverse event (gestational diabetes) was judged as possibly related to study medication. All 16 infants born to women remaining in the study at delivery were HIV-1 negative (two were premature). CONCLUSIONS: Total darunavir exposure decreased during pregnancy, but the decrease was less for unbound (active) darunavir. These changes are not considered clinically relevant. Darunavir/ritonavir 800/100 mg qd may therefore be a treatment option for HIV-1-infected pregnant women.


Asunto(s)
Fármacos Anti-VIH/administración & dosificación , Fármacos Anti-VIH/farmacocinética , Darunavir/administración & dosificación , Darunavir/farmacocinética , Infecciones por VIH/tratamiento farmacológico , Ritonavir/administración & dosificación , Ritonavir/farmacocinética , Adolescente , Adulto , Cromatografía Líquida de Alta Presión , Femenino , Humanos , Plasma/química , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Espectrometría de Masas en Tándem , Adulto Joven
7.
Mucosal Immunol ; 9(4): 1027-38, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-26555708

RESUMEN

Sex workers practicing in high HIV endemic areas have been extensively targeted to test anti-HIV prophylactic strategies. We hypothesize that in women with high levels of genital exposure to semen changes in cervico-vaginal mucosal and/or systemic immune activation will contribute to a decreased susceptibility to HIV-1 infection. To address this question, we assessed sexual activity and immune activation status (in peripheral blood), as well as cellular infiltrates and gene expression in ectocervical mucosa biopsies in female sex workers (FSWs; n=50), as compared with control women (CG; n=32). FSWs had low-to-absent HIV-1-specific immune responses with significantly lower CD38 expression on circulating CD4(+) or CD8(+) T-cells (both: P<0.001) together with lower cervical gene expression of genes associated with leukocyte homing and chemotaxis. FSWs also had increased levels of interferon-ɛ (IFNɛ) gene and protein expression in the cervical epithelium together with reduced expression of genes associated with HIV-1 integration and replication. A correlative relationship between semen exposure and elevated type-1 IFN expression in FSWs was also established. Overall, our data suggest that long-term condomless sex work can result in multiple changes within the cervico-vaginal compartment that would contribute to sustaining a lower susceptibility for HIV-1 infection in the absence of HIV-specific responses.


Asunto(s)
Linfocitos T CD4-Positivos/fisiología , Linfocitos T CD8-positivos/fisiología , Infecciones por VIH/inmunología , VIH-1/fisiología , Interferones/metabolismo , Membrana Mucosa/inmunología , Trabajadores Sexuales , Adulto , Cuello del Útero/patología , Susceptibilidad a Enfermedades , Femenino , Regulación Viral de la Expresión Génica , Humanos , Tolerancia Inmunológica , Interferón Tipo I/metabolismo , Interferones/genética , Activación de Linfocitos/genética , Membrana Mucosa/virología , Semen/inmunología , Conducta Sexual , Integración Viral/genética , Replicación Viral/genética
8.
HIV Med ; 15(1): 50-6, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-23731450

RESUMEN

OBJECTIVES: Antiretroviral therapy during pregnancy is recommended to reduce the risk of mother-to-child transmission of HIV and for maternal care management. Physiological changes during pregnancy can affect pharmacokinetics, potentially altering pharmacological activity. We therefore evaluated the pharmacokinetics of twice-daily (bid) darunavir in HIV-1-infected pregnant women. METHODS: HIV-1-infected pregnant women receiving an antiretroviral regimen containing darunavir/ritonavir 600/100 mg bid were enrolled in this study. Total and unbound darunavir and total ritonavir plasma concentrations were obtained over 12 h during the second and third trimesters and postpartum. Total darunavir and ritonavir plasma concentrations were determined using a validated high-performance liquid chromatography tandem mass spectrometry assay and unbound darunavir was determined using (14) C-darunavir-fortified plasma. Pharmacokinetic parameters were derived using noncompartmental analysis. RESULTS: Data were available for 14 women. The area under the plasma concentration-time curve from 0 to 12 h (AUC12h) for total darunavir was 17-24% lower during pregnancy than postpartum. The AUC12h for unbound darunavir was minimally reduced during pregnancy vs. postpartum. The minimum plasma concentration (Cmin) of total and unbound darunavir was on average 43-86% and 10-14% higher, respectively, during pregnancy vs. postpartum. The antiviral response (< 50 HIV-1 RNA copies/mL) was 33% at baseline and increased to 73-90% during treatment; the percentage CD4 count increased over time. One serious adverse event was reported (increased transaminase). All 12 infants born to women remaining in the study at delivery were HIV-1-negative; four of these infants were premature. CONCLUSIONS: Total darunavir exposure decreased during pregnancy. No clinically relevant change in unbound (active) darunavir occurred during pregnancy, suggesting that no dose adjustment is required for darunavir/ritonavir 600/100 mg bid in pregnant women.


Asunto(s)
Infecciones por VIH/metabolismo , Inhibidores de la Proteasa del VIH/farmacocinética , VIH-1 , Complicaciones Infecciosas del Embarazo/metabolismo , Ritonavir/farmacocinética , Sulfonamidas/farmacocinética , Adolescente , Adulto , Darunavir , Esquema de Medicación , Femenino , Sangre Fetal/química , Infecciones por VIH/tratamiento farmacológico , Inhibidores de la Proteasa del VIH/administración & dosificación , Humanos , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Resultado del Embarazo , Ritonavir/administración & dosificación , Sulfonamidas/administración & dosificación , Adulto Joven
9.
HIV Med ; 12(9): 570-9, 2011 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-21569187

RESUMEN

OBJECTIVE: There are limited antiretroviral options for use in the treatment of HIV infection during pregnancy. The purpose of this study was to assess the safety, efficacy and appropriate dosing regimen for ritonavir (RTV)-boosted atazanavir in HIV-1-infected pregnant women. METHODS: In this nonrandomized, open-label study, HIV-infected pregnant women were dosed with either 300/100 mg (n=20) or 400/100 mg (n=21) atazanavir/RTV once-daily (qd) in combination with zidovudine (300 mg) and lamivudine (150 mg) twice daily in the third trimester. Pharmacokinetic parameters [maximum observed plasma concentration (C(max) ), trough observed plasma concentration 24 hour post dose (C(min) ) and area under concentration-time curve in one dosing interval (AUC(τ) )] were determined and compared with historical values (300/100 mg atazanavir/RTV) for HIV-infected nonpregnant adults (n=23). RESULTS: At or before delivery, all mothers achieved HIV RNA <50 HIV-1 RNA copies/mL and all infants were HIV DNA negative at 6 months of age. The third trimester AUC(τ) for atazanavir/RTV 300/100 mg was 21% lower than historical data, but the C(min) values were comparable. The C(min) value for atazanavir/RTV 400/100 mg was 39% higher than the C(min) for atazanavir/RTV 300/100 mg in historical controls, but the AUC(τ) values were comparable. Twice as many patients in the 400/100 mg group (62%) had an increase in total bilirubin (>2.5 times the upper limit of normal) as in the 300/100 mg group (30%). Atazanavir (ATV) was well tolerated with no unanticipated adverse events. CONCLUSIONS: In this study, use of atazanavir/RTV 300/100 mg qd produced C(min) comparable to historical data in nonpregnant HIV-infected adults. When used in combination with zidovudine/lamivudine, it suppressed HIV RNA in all mothers and prevented mother-to-child transmission of HIV-1 infection. During pregnancy, the pharmacokinetics, safety and efficacy demonstrated that a dose adjustment is not required for ATV.


Asunto(s)
Infecciones por VIH/prevención & control , Inhibidores de la Proteasa del VIH/farmacocinética , VIH-1 , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Oligopéptidos/farmacocinética , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Piridinas/farmacocinética , Ritonavir/farmacocinética , Adulto , Sulfato de Atazanavir , Recuento de Linfocito CD4 , Esquema de Medicación , Quimioterapia Combinada , Femenino , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/inmunología , Infecciones por VIH/transmisión , Inhibidores de la Proteasa del VIH/administración & dosificación , VIH-1/inmunología , Humanos , Oligopéptidos/administración & dosificación , Embarazo , Complicaciones Infecciosas del Embarazo/virología , Puerto Rico/epidemiología , Piridinas/administración & dosificación , Ritonavir/administración & dosificación , Sudáfrica/epidemiología , Estados Unidos/epidemiología , Carga Viral
10.
J Nanosci Nanotechnol ; 9(3): 1935-41, 2009 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19435062

RESUMEN

Bimetallic Pd/Pt nanoparticles were synthesized by bio-reduction method. The structural characterizations were performed by high resolution transmission electron microscope and energy dispersive spectroscopy. The size distribution, shapes, structures and elemental distribution were studied for the synthesized samples. Molecular simulation methods based on quantum mechanics have been applied to acquire the further information on their structural stability, electronic properties etc. The results show that the particle size for the pH = 4 was bimodal with an average particle size of 3.2 nm and a variance of 1.8 nm. While for pH is 7 the average is 3.9 nm about the variance increase up to 3.7 nm, and larger particles can be found. By the HREM micrographs, it is identified fcc-like clusters with a few planar defects, which may be pure Pd or Pt, or bimetallic Pd/Pt. Theoretically the most stable configuration corresponds to the Pd18Pt37 eutectic-like structure, which implies a cluster in cluster form.


Asunto(s)
Nanopartículas del Metal , Microscopía Electrónica de Transmisión , Paladio/química , Platino (Metal)/química , Simulación por Computador , Concentración de Iones de Hidrógeno , Nanopartículas del Metal/química , Nanopartículas del Metal/ultraestructura , Modelos Químicos , Modelos Moleculares , Termodinámica
11.
AIDS Care ; 20(8): 958-68, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18608073

RESUMEN

Among women with HIV infection, pregnancy is a time when maintenance of maternal health and reduction of vertical HIV transmission are primary concerns. Few studies have examined adherence to Antiretroviral Treatment (ART) during pregnancy and in the postpartum period when the demands of childcare may significantly interfere with women's self-care behaviors. This study examined ART use and adherence in HIV-infected pregnant and postpartum women participating in the Women and Infants Transmission Study (WITS-IV) in the US. Adherence was assessed through a self-report interview during the third trimester of pregnancy and six-month postpartum. Data were also collected on demographics, biomedical markers and health related symptoms. During the third trimester visit, 77% (309/399) of women completed the self-report adherence measure; 61% (188/309) reported complete adherence. Factors associated with non-adherence included advanced HIV disease status, higher HIV-RNA viral load, more health-related symptoms and alcohol and tobacco use. At six-month postpartum, 55% (220/399) completed the measure; 44% (97/220) of these women reported complete adherence. Factors associated with non-adherence during the postpartum period were ethnicity, more health-related symptoms and WITS clinical site. Results of multivariate analyses using Generalized Estimated Equation analyses across the two visits revealed that more health-related symptoms, higher HIV-RNA viral load, increased alcohol use and clinical site were independently associated with ART non-adherence. These analyses indicate that medication adherence is more likely during pregnancy than postpartum in HIV-infected women, perhaps provoked by motivation to reduce vertical transmission and/or intensive antepartum surveillance. Further investigation is warranted to clarify factors implicated in women's decision-making process regarding ART medication adherence.


Asunto(s)
Antirretrovirales/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Cumplimiento de la Medicación/psicología , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Adolescente , Adulto , Femenino , Infecciones por VIH/psicología , Humanos , Periodo Posparto/psicología , Embarazo , Complicaciones Infecciosas del Embarazo/psicología , Atención Prenatal , Estados Unidos
12.
AIDS Patient Care STDS ; 21(12): 930-41, 2007 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18154490

RESUMEN

HIV infection is increasing in minority groups, particularly in African American and Hispanic women. Although the incidence of HIV dementia has decreased since the advent of highly active antiretroviral treatment, prevalence of neurocognitive complications has increased as patients are now living longer. This study's purpose was to determine the psychometric properties of the Spanish-language HIV Dementia Scale (HDS) in a group of HIV-infected women. We recruited 96 women: 60 HIV-seropositive and 36 HIV-seronegative. Modification of the HDS into a Spanish-language version consisted of translating the instructions, substituting four words in Spanish (gato, media, azul, piña), increasing 1 second in the psychomotor speed because the Spanish alphabet has more letters than the English alphabet, and not offering clues for memory recall. Cognitive impairment (CI) was defined according to the modified American Academy of Neurology HIV-dementia criteria including an asymptomatic CI group. Statistical analysis consisted of analysis of variance to determine group differences and receiver operator characteristics (ROC) to determine the optimal cutoff point for the screening of CI. HDS-Spanish total score and subscores for psychomotor speed and memory recall showed significant differences between HIV-seronegative and women with HIV-dementia (p < 0.001) and between HIV-seropositive women with normal cognition and those with HIV-dementia (p < 0.001). The optimal cutoff point of 13 or less had performance characteristics of 87% sensitivity and 46% specificity for HIV-associated CI (50.0% positive predictive value, 85.0% negative predictive value). The HDS-Spanish translation offers a useful screening tool with value for the identification of Hispanic women at risk of developing HIV-associated symptomatic neurocognitive disturbances.


Asunto(s)
Complejo SIDA Demencia/clasificación , Complejo SIDA Demencia/diagnóstico , Complejo SIDA Demencia/epidemiología , Adulto , Depresión/clasificación , Femenino , Seronegatividad para VIH , Seropositividad para VIH , Humanos , Pruebas de Inteligencia , Memoria , Persona de Mediana Edad , Estudios Prospectivos , Psicometría , Desempeño Psicomotor , Puerto Rico/epidemiología , Curva ROC , Reproducibilidad de los Resultados
13.
P. R. health sci. j ; 26(4): 329-335, Dec. 2007.
Artículo en Inglés | LILACS | ID: lil-491646

RESUMEN

The AIDS pandemic had a significant impact in Puerto Rico, especially among the heterosexual populations, in particular women. Women are one of the fastest growing risk groups with HIV/AIDS in the USA and constitute about half of the AIDS cases in the world. During the past 10 years Puerto Rico has ranked among the top 5 jurisdictions in the United States in AIDS cases rates, among men, women and children. In 1987 a universal prenatal HIV screening program was implemented in the University Hospital catchment area consisting of approximately 5,000 deliveries per year. Because of the early identification of pregnant women living with HIV, access to lifesaving clinical research and the implementation of multiple strategies and comprehensive care, the perinatal HIV transmission has been reduced to zero since 1997, with a blip of one case in 2002, and none since then. The availability and access to clinical and behavioral research has been one of the key elements for this success story. The programs involved and responsible for this spectacular outcome, namely the Maternal Infant Studies Center (CEMI-Spanish Acronym) and Gamma Projects at the University of Puerto Rico School of Medicine are described. The cost savings impact of stopping mother-infant perinatal HIV-1 transmission has been calculated to be approximately $34 to $58 million dollars in 10 years. The impact of the effectiveness of these programs in having healthy uninfected infants, prolonging and improving the quality of life of those living with HIV, and providing hope to families affected by this epidemic is incalculable.


Asunto(s)
Humanos , Transmisión Vertical de Enfermedad Infecciosa , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Facultades de Medicina , Evaluación de Programas y Proyectos de Salud , Puerto Rico
14.
J Nanosci Nanotechnol ; 6(1): 151-6, 2006 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-16573087

RESUMEN

The bio-reduction method is reported as a part of a complimentary self-sustained technology, where bioremediation and metal particle production are related. The use of the characterization methods in this self sustainable technique open the expectative to be used for several other elements and with other plants, which will be discussed. However, the particular case of Mn nanoparticles involves an important option to generate nanoparticles in the range of 1-4 nanometers with a well controlled size and with a structure based on an fcc-like geometry for the smallest clusters and with more complex arrays for cluster greater than four shells, which involves magnetic moments significantly related to their atomistic configuration. At the same time, the use of the characterization methods establishes the dependence of the nanoparticle's size on the pH conditions used during the synthesis; small clusters in the range of 1-2 nm were generated using pH=5, and it was shown that for the smallest aggregates, simple polyhedron shapes are stable.


Asunto(s)
Eichhornia/química , Manganeso/química , Biomasa , Eichhornia/ultraestructura , Microscopía Electrónica , Microscopía Electrónica de Rastreo , Nanoestructuras/química , Oxidación-Reducción , Teoría Cuántica
15.
Cell Mol Biol (Noisy-le-grand) ; 49(8): 1187-92, 2003 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-14983985

RESUMEN

One of the most remarkable advances in the control of the HIV/AIDS pandemic has been the introduction of highly active antiretroviral therapy (HAART). The use of HAART has been associated to reductions in AIDS-related mortality in most countries where HAART is available. Unfortunately, the adherence required to keep good control of viral replication is higher than what is required in other medical conditions. Several studies have shown a relationship between adherence and viral suppression ranging between 90-95% required for complete suppression. Multiple factors have been related to adherence among which are: gender, racial/ethnic distribution, age, personality traits, education, alcohol use and others. For women living with HIV there might be additional difficulties to handle in order to be adherent (i.e. multiple family responsibilities). A group of 165 women living with HIV attending a multidisciplinary clinic were interviewed with a 3-day adherence questionnaire. Correlation with clinical information was obtained from the Clinic Data Base. A total of 37 pregnant and 128 non-pregnant women were included in this analysis, 96% of which were on HAART. Complete adherence (100%) was reported by 91% of the pregnant and 70% of the non-pregnant women. (Fisher's exact test 0.009). The majority, 99% knew the names of their medications. There were no differences among groups in scholarity, history or actual cigarette smoking, history or actual drug use, CD4 lymphocyte counts (median or proportion below 350 cells/mm3), mean HIV RNA viral load or the proportion of patients with HIV RNA < 1,000 copies/ml. The transmission rate for the sample of pregnant women was zero. The reported adherence rates to HAART for women living with HIV were highest among the pregnant women. This difference was statistically significant (Chi Sq 0.05). The great majority (93%) reported knowing the names of the medications. In spite of reported barriers to adherence, pregnant women attending a multidisciplinary clinic for HIV care and research, reported good rates of adherence to HAART. This is also reflected in the good perinatal outcomes. Non-pregnant women with lower adherence rates might need additional interventions to improve adherence.


Asunto(s)
Terapia Antirretroviral Altamente Activa , Infecciones por VIH/tratamiento farmacológico , Cooperación del Paciente/estadística & datos numéricos , Adulto , Conducta , Recuento de Linfocito CD4 , Distribución de Chi-Cuadrado , Femenino , Infecciones por VIH/psicología , Infecciones por VIH/transmisión , Humanos , Atención Perinatal , Embarazo , Resultado del Embarazo , Encuestas y Cuestionarios
16.
HIV Clin Trials ; 2(6): 460-5, 2001.
Artículo en Inglés | MEDLINE | ID: mdl-11742433

RESUMEN

PURPOSE: To evaluate saquinavir (SQV) pharmacokinetics, tolerance, and safety in 10 HIV-infected pregnant women between 14-32 weeks gestation. METHOD: This was a phase I, prospective, area-under-the-curve (AUC) targeted study. Antepartum treatment consisted of SQV 1200 mg tid, lamivudine 150 mg bid, and zidovudine 200 mg tid. The SQV targeted exposure was an 8-hour AUC (AUC(8)) of 3000 ng. h/mL; the study was to be halted if the first 4 participants did not achieve this AUC(8). Cord blood and plasma samples were collected in neonates at birth. RESULTS: Four women completed the SQV pharmacokinetic assessments. Exposure in all 4 patients was below the target AUC(8). Median (range) AUC(8) and trough (C8H) were 1672 (738-2614) ng. h/mL and 60 (<15-332) ng/mL, respectively. Oral clearance (CL/F) was 9.3 (5.1-16.6) L/h/kg and C(max) was 599 (177-953) ng/mL. Cord and neonate plasma concentrations were mostly undetectable; 1 of 5 infants was HIV-infected at 24 weeks. CONCLUSION: These data suggest highly variable SQV pharmacokinetics in pregnant women, and exposure at 1200 mg tid may not be adequate for longer term therapy; both the AUC(8) and C8H were considerably below average. Because ritonavir has been shown to significantly increase SQV concentrations, this combination should be further explored in this population.


Asunto(s)
Infecciones por VIH/tratamiento farmacológico , Inhibidores de la Proteasa del VIH/farmacocinética , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Saquinavir/farmacocinética , Adulto , Fármacos Anti-VIH/uso terapéutico , Área Bajo la Curva , Cápsulas , Quimioterapia Combinada , Femenino , Gelatina , Infecciones por VIH/metabolismo , Infecciones por VIH/transmisión , Inhibidores de la Proteasa del VIH/uso terapéutico , Humanos , Recién Nacido , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Lamivudine/uso terapéutico , Embarazo , Complicaciones Infecciosas del Embarazo/metabolismo , Complicaciones Infecciosas del Embarazo/virología , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Saquinavir/uso terapéutico , Zidovudina/uso terapéutico
17.
J Acquir Immune Defic Syndr ; 26(3): 236-45, 2001 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-11242196

RESUMEN

Cesarean delivery before onset of labor and rupture of membranes (i.e., scheduled cesarean delivery) is associated with a lower risk of vertical transmission of HIV. The following a priori hypotheses were tested: among HIV-infected women, scheduled cesarean delivery is associated with a higher risk of postpartum morbidity, longer hospitalization, and a higher risk of rehospitalization than spontaneous vaginal delivery. Postpartum morbidity occurred following 178 of 1,186 (15%) of deliveries during 1990 to 1998 in The Women and Infants Transmission Study. The most commonly reported postpartum morbidity events were: fever without infection, hemorrhage or severe anemia, endometritis, urinary tract infection, and cesarean wound complications. Several time trends were observed: the median duration of ruptured membranes decreased (p < .001), intrapartum antibiotic use increased (p < .001), the median antepartum plasma HIV RNA concentration decreased (p < .001), and the incidence of any postpartum morbidity decreased (p = .02). With spontaneous vaginal delivery as the reference category, both scheduled (odds ratio [OR] = 4.69; 95% confidence interval [95% CI], 2.03-10.84), and nonscheduled (OR, 2.50; 95% CI, 1.24-5.04) cesarean deliveries were associated with fever without infection; with urinary tract infection (OR, 3.79; 95% CI 1.04-13.85; OR, 3.86; 95% CI, 1.55-9.60, respectively), and with any postpartum morbidity (OR, 3.19; 95% CI 1.69-6.00; OR, 4.10; 95% CI, 2.71-6.19, respectively). Nonscheduled cesarean deliveries were more likely to be complicated by endometritis (OR, 6.98; 95% CI, 3.53-13.78). Adjusted ORs relating mode of delivery and each of the outcomes (fever without infection, urinary tract infection, endometritis, and any postpartum morbidity) were similar to unadjusted ORs. Results of this analysis indicate scheduled cesarean delivery is associated with an increased risk of any postpartum morbidity and, specifically, postpartum fever without infection. The potential for postpartum morbidity with scheduled cesarean delivery should be considered in light of possible adverse events associated with other interventions to decrease the risk of vertical transmission of HIV. Counseling of HIV-infected pregnant women regarding scheduled cesarean delivery as a possible intervention to decrease maternal-infant transmission of HIV should include discussion of these results, as well as new data as they become available, regarding the incidence and severity of postpartum morbidity events among HIV-infected women according to mode of delivery.


Asunto(s)
Cesárea/efectos adversos , Parto Obstétrico/métodos , Infecciones por VIH , Transmisión Vertical de Enfermedad Infecciosa , Complicaciones Infecciosas del Embarazo , Trastornos Puerperales/epidemiología , Estudios de Cohortes , Parto Obstétrico/efectos adversos , Extracción Obstétrica , Femenino , Infecciones por VIH/complicaciones , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , VIH-1 , Hospitalización , Humanos , Recién Nacido , Tiempo de Internación , Morbilidad , Análisis Multivariante , Oportunidad Relativa , Periodo Posparto , Embarazo , Complicaciones Infecciosas del Embarazo/virología , Estudios Prospectivos , Trastornos Puerperales/etiología , ARN Viral/sangre
18.
J Acquir Immune Defic Syndr ; 25(4): 306-11, 2000 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-11114830

RESUMEN

CONTEXT: Despite the success of highly active antiretroviral therapy, the optimal approach for preventing perinatal HIV-1 transmission is not known. OBJECTIVE: A retrospective survey was conducted at six centers in the United States and Puerto Rico from January 1997 to October 1998 to evaluate the effects of protease inhibitor use during pregnancy on maternal and infant safety, prematurity rate, and frequency of perinatal HIV-1 transmission. RESULTS: In the study, 91 live infants, including 3 sets of twins, and 1 neonate who died shortly after birth were born to 89 women. HIV perinatal transmission rate in this series was 0 (95% confidence interval [CI], 0%-3%). Prematurity rate was 19.1%, comparable to rates in earlier reports of HIV-1-infected women. In multiple regression analysis, only cocaine use and premature rupture of membranes were associated with prematurity (p =.03 and.008, respectively). The gestational week during which the protease inhibitors were initiated was not found to be significantly associated with prematurity. Adverse maternal, obstetric, and infant events possibly related to protease inhibitors were uncommon. CONCLUSIONS: Protease inhibitors appeared generally safe in mothers and infants in this series. No perinatal HIV-1 transmission occurred. Further prospective, controlled studies are needed to define the optimal management of HIV-1 in pregnancy.


Asunto(s)
Terapia Antirretroviral Altamente Activa , Infecciones por VIH/transmisión , Inhibidores de la Proteasa del VIH/administración & dosificación , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Adolescente , Adulto , Puntaje de Apgar , Linfocitos T CD4-Positivos , Femenino , Infecciones por VIH/prevención & control , Humanos , Lamivudine/administración & dosificación , Modelos Lineales , Estudios Multicéntricos como Asunto , Embarazo , Puerto Rico , Análisis de Regresión , Estudios Retrospectivos , Inhibidores de la Transcriptasa Inversa/administración & dosificación , Encuestas y Cuestionarios , Estados Unidos , Carga Viral , Zidovudina/administración & dosificación
19.
Int J Fertil Womens Med ; 45(2): 195-9, 2000.
Artículo en Inglés | MEDLINE | ID: mdl-10831190

RESUMEN

Women are the fastest growing segment of the AIDS cases in the United States. They constitute nearly half of all the AIDS cases worldwide. Recent advances in Highly Active Antiretroviral Therapies (HAART) have reduced AIDS mortality remarkably. But as longer use of these combination regimens makes evident, unexpected side effects are now reported that might reflect gender-based differences in occurrence. Controversy still exists in relation to the level of HIV-1 quantification in men and women and its association with disease progression. Women have been reported to have lower viral loads with equal progression or higher progression with equal viral loads. This finding has not been consistent in all studies. Psychosocial variables, such as poverty, lack of care and young age, adversely affect more women than men. If the viral dynamics are thought to be different, then the response to treatment might be as well. So far, the effectiveness of HAART has been seen equally among men and women. Barriers to adherence, such as caregiving burdens, multiplicity of roles and fear of disclosure, might disproportionately affect women. By far the best news is that the survival of both men and women has improved with the newer therapeutic advances.


Asunto(s)
Fármacos Anti-VIH/administración & dosificación , Infecciones por VIH/tratamiento farmacológico , VIH-1/efectos de los fármacos , Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Síndrome de Inmunodeficiencia Adquirida/mortalidad , Adolescente , Adulto , Quimioterapia Combinada , Femenino , Infecciones por VIH/mortalidad , Infecciones por VIH/virología , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Medición de Riesgo , Factores Sexuales , Análisis de Supervivencia , Resultado del Tratamiento , Carga Viral
20.
P R Health Sci J ; 19(1): 29-34, 2000 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-10761202

RESUMEN

During the past five years there have been significant advances in the knowledge of the factors that affect mother-to-infant HIV-1 transmission. Diverse interventions have been designed and proven effective in reducing the risk of such transmission. In reviewing the pivotal literature in such respect implications for public policy are also analyzed. Because of the constant evolution of the interventions, the public policies also need constant revisions. The impact of viral load assessment during pregnancy and its relationship to transmission risks is discussed, as well as the effectiveness of elective Caesarean delivery. The latter has both positive and negative aspects which merit consideration. Newer approaches, such as highly active anti retroviral therapies (HAART), which have shown to decrease the AIDS mortality, have also shown zero transmission in small cohorts. Shorter and cheaper interventions are also somewhat effective and are good alternatives to resource poor countries.


Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/transmisión , Fármacos Anti-VIH/uso terapéutico , VIH-1 , Transmisión Vertical de Enfermedad Infecciosa , Complicaciones Infecciosas del Embarazo , Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Síndrome de Inmunodeficiencia Adquirida/prevención & control , Adulto , Cesárea , Ensayos Clínicos como Asunto , Femenino , VIH-1/genética , VIH-1/aislamiento & purificación , Humanos , Recién Nacido , Lamivudine/uso terapéutico , Masculino , Monitoreo Fisiológico , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Política Pública , ARN Viral/análisis , Sistema de Registros , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Factores de Riesgo , Carga Viral , Zidovudina/uso terapéutico
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