scholarly journals Transdermal Testosterone Administration in Women with Acquired Immunodeficiency Syndrome Wasting: A Pilot Study1

1998 ◽  
Vol 83 (8) ◽  
pp. 2717-2725 ◽  
Author(s):  
Karen Miller ◽  
Colleen Corcoran ◽  
Catharina Armstrong ◽  
Kim Caramelli ◽  
Ellen Anderson ◽  
...  

abstract Although human immunodeficiency virus (HIV) disease is increasing rapidly among women, no prior studies have investigated gender-based therapeutic strategies for the treatment of acquired immunodeficiency syndrome (AIDS) and its complications in this population. Markedly decreased serum androgen levels have been demonstrated in women with AIDS and may be a contributing factor to the wasting syndrome in this population. To assess the effects of androgen replacement therapy in women with AIDS wasting, we conducted a randomized, placebo-controlled, pilot study of transdermal testosterone administration. The primary aim of the study was to determine efficacy in terms of the change in serum testosterone levels, safety parameters and tolerability. A secondary aim of the study was to investigate testosterone effects on weight, body composition, quality of life, and functional indexes. Fifty-three ambulatory women with the AIDS wasting syndrome defined as weight less than 90% of ideal body weight or weight loss of more than 10% of the preillness maximum, free of new opportunistic infection within 6 weeks of study initiation, and with screening serum levels of free testosterone less than the mean of the normal reference range (<3 pg/mL) were enrolled in the study. Subjects were age 37 ± 1 yr old (mean ± sem), weighed 92 ± 2% of ideal body weight, and had lost 17 ± 1% of their maximum weight. CD4 count was 324 ± 36 cells/mm3, and viral burden was 102,382 ± 28,580 copies. Subjects were randomized into three treatment groups, in which two placebo patches (PP), one active/one placebo patch (AP group), or two active patches (AA group) were applied twice weekly to the abdomen for 12 weeks. The expected nominal delivery rates of testosterone were 150 and 300 μg/day, respectively, for the AP and AA groups. Forty-five subjects completed the study (PP group, n = 13; AP group, n = 14; AA group, n = 18). Two additional subjects from the PP group and two from the AP group were included in the intent to treat analysis. Serum free testosterone levels increased significantly from 1.2 ± 0.2 to 5.9 ± 0.8 pg/mL (AP) and from 1.9 ± 0.4 to 12.4 ± 1.6 pg/mL (AA) in response to testosterone administration (P < 0.0001 for comparison of AA vs. PP and AP vs. PP; normal range, 1.3–6.8 pg/mL). Testosterone administration was generally well tolerated locally and systemically, with no adverse trends in hirsutism scores, lipid profiles, or liver function tests. Weight increased significantly in the AP group (1.9 ± 0.7 kg) vs. the PP group (0.6 ± 0.8 kg; P = 0.043), but did not increase significantly in the AA group (0.9 ± 0.4 kg; P = 0.263 vs. PP, by mixed effects model assessing the interaction of time and treatment on all available data, one-tailed test). Improved social functioning (P = 0.024, by one-tailed test) and a trend toward improved pain score (P = 0.059) were observed in the AP vs. the PP-treated patients (RAND 36-Item Health Survey questionnaire). Five of six previously amenorrheic patients in the AP group had spontaneous resumption of menses compared to only one of four amenorrheic patients in the AA group (P = 0.045 for comparison of actual number of periods during the study). This study is the first investigation of testosterone administration in women with AIDS wasting. We demonstrate a novel method to augment testosterone levels in such patients that is safe and well tolerated during short term administration. At the lower of the two doses administered in this study, testosterone therapy was associated with positive trends in weight gain and quality of life. Higher, more supraphysiological, dosing was not associated with positive trends in weight or overall well-being. These data suggest that testosterone administration may improve the status of women with AIDS wasting. Further studies are needed to assess the effects of testosterone on weight in HIV-infected women and to define the optimal therapeutic window for testosterone administration in this population.

2000 ◽  
Vol 85 (1) ◽  
pp. 35-41
Author(s):  
Colleen Hadigan ◽  
Colleen Corcoran ◽  
Takara Stanley ◽  
Sarah Piecuch ◽  
Anne Klibanski ◽  
...  

Fat redistribution in the setting of protease inhibitor use is increasingly common and is associated with insulin resistance in human immunodeficiency virus (HIV)-infected patients. However, little is known regarding the factors that may contribute to abnormal insulin regulation in this population. We assessed fasting insulin levels in HIV-infected men and determined the relationship among insulin, body composition, endogenous gonadal steroid concentrations, and antiviral therapy in this population. We also determined the effects of exogenous testosterone administration using the homeostatic model for insulin resistance (HOMA IR) in hypogonadal HIV-infected men with the acquired immunodeficiency syndrome wasting syndrome. Fifty HIV-infected men with acquired immunodeficiency syndrome wasting were compared with 20 age- and body mass index (BMI)-matched healthy control subjects. Insulin concentrations were significantly increased in HIV-infected patients compared to those in control patients (16.6 ± 1.8 vs. 10.4 ± 0.8 μU/mL; P < 0.05) and were increased in nucleoside reverse transcriptase (NRTI)-treated patients who did not receive a protease inhibitor (PI; 21.7 ± 4.3 vs. 10.4 ± 0.8μ U/mL; P < 0.05). Insulin concentrations and HOMA IR were inversely correlated with the serum free testosterone concentration (r = −0.36; P = 0.01 for insulin level; r = −0.30; P = 0.03 for HOMA), but not to body composition parameters, age, or BMI. In a multivariate regression analysis, free testosterone (P = 0.05), BMI (P < 0.01), and lean body mass (P = 0.04) were significant. Lower lean body mass and higher BMI predicted increased insulin resistance. The HIV-infected patients demonstrated an increased trunk fat to total fat ratio (0.49 ± 0.02 vs. 0.45 ± 0.02; P < 0.05) and an increased trunk fat to extremity fat ratio (1.27 ± 0.09 vs. 0.95 ± 0.06, P = 0.01), but a reduced extremity fat to total fat ratio (0.44 ± 0.01 vs. 0.49 ± 0.01; P = 0.02) and reduced overall total body fat (13.8 ± 0.7 vs. 17.2 ± 0.9 kg; P < 0.01) compared to the control subjects. Increased truncal fat and reduced extremity fat were seen among NRTI-treated patients, but this pattern was most severe among patients receiving combined NRTI and PI therapy [trunk fat to extremity ratio, 1.47 ± 0.15 vs. 0.95 ± 0.06 (P < 0.01); extremity fat to total fat ratio, 0.40 ± 0.02 vs. 0.49 ± 0.01 (P < 0.05)]. Insulin responses to testosterone administration were investigated among 52 HIV-infected men with hypogonadism and wasting (weight <90% ideal body weight and/or weight loss >10%) randomized to either testosterone (300 mg, im, every 3 weeks) or placebo for 6 months. Testosterone administration reduced HOMA IR in the HIV-infected men (−0.6 ± 0.7 vs. +1.41 ± 0.8, testosterone vs. placebo, P = 0.05) in association with increased lean body mass (P = 0.02). These data demonstrate significant hyperinsulinemia in HIV-infected patients, which can occur in the absence of PI use. In NRTI-treated patients not receiving PI, a precursor phenotype is apparent, with increased truncal fat, reduced extremity fat, and increased insulin concentrations. This phenotype is exaggerated in patients receiving PI therapy, with further increased truncal fat and reduced extremity fat, although hyperinsulinemia per se is not worse. Endogenous gonadal steroid levels are inversely related to hyperinsulinemia in HIV-infected men, but reduced lean body mass and increased weight are the primary independent predictors of hyperinsulinemia. Indexes of insulin sensitivity improve in response to physiological androgen administration among hypogonadal HIV-infected patients, and this change is again related primarily to increased lean body mass in response to testosterone administration.


1996 ◽  
Vol 7 (1_suppl) ◽  
pp. 34-37 ◽  
Author(s):  
J A Mccutchan

Prevention of opportunistic infections contributes to improved quality of life and survival in individuals with acquired immunodeficiency syndrome (AIDS). Agents which are more effective and convenient, less costly, and better tolerated are needed for multiple organism primary prophylaxis. Azithromycin, an azalide with high and prolonged intracellular levels, promises to provide protection against Mycobacterium avium complex (MAC) disease in those with advanced AIDS when given weekly. A large trial comparing rifabutin (300 mg daily), a currently approved primary prophylactic agent for MAC, with azithromycin (1200 mg weekly) has been completed and is under analysis. If weekly azithromycin provides equivalent or better protection from disseminated MAC, the cost, effectiveness and convenience of MAC prophylaxis may be improved.


Author(s):  
Sasikala M. Chinnappan ◽  
Annie George ◽  
Pragya Pandey ◽  
Govinda Narke ◽  
Yogendra Kumar Choudhary

Background: Low testosterone levels cause physiological changes that compromise the quality of life in ageing men. A standardised water extract from the root of Eurycoma longifolia (EL), known as Physta®, is known to increase testosterone levels. Objective: To evaluate the safety and efficacy of Physta® in improving the testosterone levels and quality of life in ageing male subjects. Design: This randomised, double-blind, placebo-controlled study enrolled 105 male subjects aged 50–70 years with a testosterone level <300 ng/dL, BMI ≥ 18 and ≤30.0 kg/m2. The subjects were given either Physta® 100 mg, 200 mg or placebo daily for 12 weeks. The primary endpoints were changes in serum total and free testosterone levels. The secondary endpoints included changes in the level of sex hormone-binding globulin (SHBG), dihydroepiandrosterone (DHEA), glycated haemoglobin (HbA1c), insulin-like growth factor-1 (IGF-1), thyroid function tests (T3, T4, TSH and Free T3) and cortisol. Changes in Ageing Male Symptoms (AMS) score, Fatigue Severity Scale (FSS) score and muscle strength are other secondary endpoints. The safety of the intervention products was measured by complete blood count, lipid profile, liver and renal function tests. Results: There was a significant increase in the total testosterone levels at week 12 (P < 0.05) in the Physta® 100 mg group and at weeks 4 (P < 0.05), 8 (P < 0.01) and 12 (P < 0.001) in the Physta® 200 mg group compared to placebo. No significant between-group differences in free testosterone levels were observed but a significant within-group increase occurred at weeks 4 (P < 0.01), 8 (P < 0.001) and 12 (P < 0.001) in the Physta®100 mg group and at weeks 2 (P < 0.01), 4 (P < 0.01), 8 (P < 0.001) and 12 (P < 0.001) in the Physta® 200 mg group. The AMS and FSS showed significant reduction (P < 0.001) in total scores at all time-points within- and between-group in both Physta® groups. DHEA levels significantly increased (P < 0.05) within-group in both Physta® groups from week 2 onwards. Cortisol levels significantly (P < 0.01) decreased in the Physta® 200 mg group, while muscle strength significantly (P < 0.001) increased in both Physta® groups at week 12 in the within-group comparison. There were no significant changes in SHBG. No safety related clinically relevant changes were observed. Conclusion: Supplementation of Physta® at 200 mg was able to increase the serum total testosterone, reduce fatigue and improve the quality of life in ageing men within 2 weeks’ time. Trial registration: This clinical study has been registered in ctri.nic.in (CTRI/2019/03/017959).


2017 ◽  
Vol 62 (3) ◽  
Author(s):  
Hayriye Kirkoyun Uysal ◽  
Gokhan Tolga Adas ◽  
Kevser Atalik ◽  
Semih Altiparmak ◽  
Ozer Akgul ◽  
...  

AbstractOpportunistic infections such as cryptosporidiosis and cyclosporiasis are commonly encountered in patients with acquired immunodeficiency syndrome (AIDS). We investigated the existence of opportunistic protozoans that significantly affect the quality of life in HIV-1 infected patients using conventional and molecular methods. The study group comprised 115 HIV-1 positive patients. In the identification of


2016 ◽  
Vol 18 (12) ◽  
pp. 947-953 ◽  
Author(s):  
Undine Christmann ◽  
Iveta Bečvářová ◽  
Stephen R Werre ◽  
Hein P Meyer

Objectives The aim of the study was to evaluate weight loss and maintenance parameters in cats fed a novel weight management food and to assess the owner’s perception of the cat’s quality of life. Methods This study was designed as a prospective, uncontrolled/unmasked clinical trial. One hundred and thirty-two overweight/obese, otherwise healthy, client-owned cats were enrolled. Initial evaluation included physical examination, nutritional assessment, ideal body weight determination and weight-loss feeding guidelines development. Follow-up evaluations (monthly for 6 months) encompassed determination of body weight, body condition score, body fat index, muscle condition score and feeding practices. Quality of life assessment by owners included the cat’s level of energy, happiness, appetite, begging behavior, flatulence, stool volume and fecal score. Results Eighty-three percent of the cats lost weight, with an average ± SEM weight loss of 11.0 ± 1.8% over 6 months and an average ± SE weekly weight loss rate of 0.45 ± 0.02%. The mean ± SEM duration of weight loss was 134.0 ± 4.8 days. Fourteen percent of cats achieved an ideal body weight. Seventy-nine percent of cats ate more calories from novel weight management food than the recommended daily energy requirement for weight loss, and the majority of these cats still lost weight. Body condition score and body fat index decreased over time compared with baseline from weeks 12–24 and from weeks 8–24, respectively. Owners perceived an increase in energy and happiness (>week 12) in the cats that lost weight, without changes in appetite or begging behavior. Conclusions and relevance This study confirmed the effectiveness of the novel weight management food in achieving weight loss in overweight/obese client-owned cats. Owners reported significant improvements in their cat’s quality of life without negative side effects.


Author(s):  
Carl A. Kirton ◽  
Deborah Witt Sherman

This chapter provides an overview and update of the comprehensive care related to HIV/AIDS and addresses the palliative care needs of individuals and families living with and dying from this illness. With this information, nurses and other health-care professionals will gain the knowledge to provide effective and compassionate care, recognizing the need for both curative and aggressive care as well as supportive and palliative therapies to maximize the quality of life of patients and their family caregivers.


2008 ◽  
Vol 3 (1) ◽  
pp. 84
Author(s):  
Laidilce Teles Zatta ◽  
Raphaela Maione Xavier ◽  
Juliano Ricardo Santana dos Santos ◽  
Vívian Watanabe de Brito ◽  
Patrícia Pereira de Vasconcelos ◽  
...  

ABSTRACTObjective: to analyze the studies about quality of life from patients with HIV/ aids. Method: this is about a literature review from 2003 to 2008. Data collection was done in databases of the Biblioteca Virtual em Saúde/BIREME and of the Scientific Electronic Library Online, from may to june 2008.The following descriptors were used: life quality, Acquired Immunodeficiency Syndrome and HIV. Results: six articles, two abstracts and a dissertation were found. Conclusions: studies about HIV/aids show a direct relationship between the social representations of aids and lifestyle, leaving obvious as the seropositivity directly influences the quality of life and should be understood in view of technology and care provided by professionals and health services. Descriptors: quality of life; acquired immunodeficiency syndrome; life style; hiv.RESUMOObjetivo: analisar estudos referentes à qualidade de vida de portadores do hiv/aids. Método: trata-se de um estudo de revisão de literatura entre 2003 a 2008, cuja coleta de dados foi realizada em Bases de Dados da Biblioteca Virtual em Saúde/BIREME e na Scientific Electronic Library Online, no período de maio a junho de 2008, utilizando-se como descritores: qualidade de vida, síndrome da imunodeficiência adquirida e HIV. Foram selecionados artigos cujos títulos ou resumos fizessem referência à qualidade de vida e ao hiv/aids. Resultados: foram encontrados seis artigos, dois resumos e uma dissertação. Conclusão: estudos sobre qualidade de portadores do HIV/aids demonstram a relação entre as representações sociais da aids e o estilo de vida, deixando evidente como a soropositividade influencia na qualidade de vida e deve ser entendida na perspectiva dos cuidados e tecnologias disponibilizadas pelos profissionais e serviços de saúde. Descritores: qualidade de vida; síndrome da imunodeficiência adquirida; estilo de vida; hiv.RESUMENObjetivos: examinar los estudios sobre la calidad de vida de las personas que viven con el VIH/SIDA. Método: se trata de un estudio de revisión de la literatura a partir de 2003 a 2008, cuya recogida de datos se llevó a cabo en bases de datos de la Biblioteca Virtual en Salud de BIREME y de la Scientific Electronic Library Online, en el período de mayo a junio de 2008, utilizando como descriptores: la calidad de vida, el síndrome de inmunodeficiencia adquirida y el VIH. Se seleccionaron los artículos cuyos títulos o resúmenes de hacer referencia a la calidad de vida y de sida. Resultados: seis artículos fueron encontrados, dos resúmenes y una disertación. Conclusión: estudios sobre VIH/SIDA muestran una relación directa entre las representaciones sociales del SIDA y estilo de vida, dejando claramente como la seropositividad influye directamente en la calidad de vida y debe ser entendida a la vista de la tecnología y la atención prestada por los profesionales y los servicios de salud. Descriptores: calidad de vida; síndrome de inmunodeficiencia adquirida; estilo de vida; vih. 


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