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Background: Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed., Objective: To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care., Methods: A randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits., Results: A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints., Conclusions: In the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.

Introduction: The prevalence of smoking is high among the human immunodeficiency virus (HIV)-infected population, yet there are few studies of tobacco dependence treatment in this population. This paper reports the safety of varenicline versus nicotine replacement therapy (NRT) and describes preliminary results about the effectiveness of varenicline versus NRT in HIV-infected smokers., Methods: Participants completed 12 weeks of telephone counseling and either varenicline or NRT. Varenicline was encouraged as the preferred intervention; NRT was used for those unable/unwilling to take varenicline. Adverse events (AEs), related to pharmacotherapy, were monitored. Biochemically confirmed abstinence at 3 months was examined. Inverse probability of treatment weighted logistic regression models was fit to compare participants on varenicline to those on NRT., Results: Among participants on varenicline (n = 118), the most common AEs were nausea, sleep problems, and mood disturbances. One person reported suicidal ideation; there were no cardiovascular complications. There were no differences in the varenicline AE profile between participants on combination antiretroviral therapy (ART) and those not on ART. The percentages of confirmed abstainers were 11.8% in the NRT group and 25.6% in the varenicline group. The odds of being abstinent were 2.54 times as great in the varenicline group compared with the NRT group in the propensity weighted model (95% CI 1.43-4.49)., Conclusions: In this preliminary study, the safety profile of varenicline among HIV-infected smokers resembles findings among smokers without HIV. In addition, varenicline may be more effective at promoting abstinence in this population. Future randomized clinical trials are warranted.

The integration of original data from multiple antiretroviral (ARV) adherence studies offers a promising, but little used method to generate evidence to advance the field. This paper provides an overview of the design and implementation of MACH14, a collaborative, multi-site study in which a large data system has been created for integrated analyses by pooling original data from 16 longitudinal ARV adherence studies. Studies selected met specific criteria including similar research design and data domains such as adherence measured with medication event monitoring system, psychosocial factors related to adherence behavior, and virologic and clinical outcomes. The data system created contains individual data (collected between 1997 and 2009) from 2,860 HIV patients. Collaboration helped resolve the challenges inherent in pooling data across multiple studies, yet produced a data system with strong statistical power and potentially greater capacity to address key scientific questions than possible with single-sample studies or even meta-analytic designs.

Background: Minority race/ethnicity is generally associated with antiretroviral therapy nonadherence in US-based studies. Limitations of the existing literature include small samples, subjective adherence measures, and inadequate control for potential confounders such as mental health and substance use, which have been consistently associated with poorer adherence., Methods: Individual-level data were pooled from 13 US-based studies employing electronic drug monitoring to assess adherence. Adherence was operationalized as percent of prescribed doses taken from the first 12 (monthly) waves of data in each study. Depression symptoms were aggregated from several widely used assessments, and substance use was operationalized as any use of cocaine/stimulants, heroin/opiates, ecstasy, hallucinogens, or sedatives in the 30-365 days preceding baseline., Results: The final analytic sample of 1809 participants ranged in age from 18 to 72 years and was 67% male. Participants were 53% African American, 14% Latino, and 34% White. In a logistic regression adjusting for age, gender, income, education, and site, race/ethnicity was significantly associated with adherence (P < 0.001) and persisted in a model that also controlled for depression and substance use (P < 0.001), with African Americans having significantly lower adherence than Latinos [odds ratio (OR) = 0.72, P = 0.04] and whites (OR = 0.60, P < 0.001). Adherence did not differ between whites and Latinos (OR = 0.84, P = 0.27)., Conclusions: Racial/ethnic differences in demographics, depression, and substance abuse do not explain the lower level of antiretroviral therapy adherence in African Americans observed in our sample. Further research is needed to explain the persistent disparity and might examine factors such as mistrust of providers, health literacy, and inequities in the health care system.

Objective: Adherence to antiretroviral therapies (ART) is the strongest predictor of viral suppression among individuals infected with HIV, however, limited data exists to understand the patterns of adherence that confer the greatest benefit across different ART regimens., Design: Longitudinal data pooled from 16 studies conducted between 1997 and 2009 across the United States., Methods: Adherence was measured using Medication Event Monitoring System. Percentage of time with sufficient drug concentrations (covered time) and the length of the longest treatment interruption during the 28 days prior to plasma HIV-RNA measurements were calculated. Logistic regression with generalized estimating equations was used to estimate medication-specific adherence estimates on detectable HIV-RNA (>400 copies/ml)., Results: One thousand and eighty-eight participants with 3795 HIV-RNA measures were studied. Both lower covered time and greater longest interruption showed dose-response relationships with the odds of detectable HIV-RNA; however, estimates did not vary by medication regimen. Compared with 93-100% coverage, periods of 0-25% covered time had a three-fold increased risk of detectable HIV-RNA [odds ratio (OR) = 3.22, 95% confidence interval (CI): 2.48-4.19]. Similarly, compared to longest interruptions of 0-48 h, longest interruptions of 21-28 days had a nearly four-fold increased risk of detectable HIV-RNA (OR = 3.65, 95% CI: 2.77, 4.81)., Conclusion: We found that adherence was consistently strongly associated with treatment response across ART regimens. Of the patterns of adherence, longer interruptions may have greater impact than covered time. Future research should investigate additional methods for examining adherence patterns, understanding the determinants of consecutive missed doses and the evaluation of interventions designed to address interruptions in treatment.

Purpose: Self-management is a dynamic process in which individuals actively manage a chronic illness. Self-management models are limited in their specification of the processes of self-management. The purpose of this article is to delineate processes of self-management in order to help direct interventions and improve health outcomes for individuals with a chronic illness., Design: Qualitative metasynthesis techniques were used to analyze 101 studies published between January 2000 and April 2011 that described processes of self-management in chronic illness., Methods: Self-management processes were extracted from each article and were coded. Similar codes were clustered into categories. The analysis continued until a final categorization was reached., Findings: Three categories of self-management processes were identified: focusing on illness needs; activating resources; and living with a chronic illness. Tasks and skills were delineated for each category., Conclusions: This metasynthesis expands on current descriptions of self-management processes by specifying a more complete spectrum of self-management processes., Clinical Relevance: Healthcare providers can best facilitate self-management by coordinating self-management activities, by recognizing that different self-management processes vary in importance to patients over time, and by having ongoing communication with patients and providers to create appropriate self-management plans., (© 2012 Sigma Theta Tau International.)

As mortality due to AIDS-related causes has decreased with the use of antiretroviral therapy, there has been a rise in deaths related to non-AIDS-defining illnesses. Given the exceedingly high prevalence of cigarette smoking among individuals living with HIV infection, tobacco has been implicated as a major contributor to this paradigm shift. Evidence suggests that smoking-related illnesses, such as cardiovascular disease, respiratory illnesses, and certain malignancies, contribute substantially to morbidity and mortality among HIV-infected persons. In this review, we summarize the adverse health consequences of smoking relevant to HIV-infected individuals and discuss smoking cessation in this unique population, including a discussion of barriers to quitting and a review of studies that have examined smoking cessation interventions.

Health-related quality of life (HRQOL) is linked to symptom status and may be related to age in HIV-positive persons. Data were collected in a multisite HIV-positive sample (N = 1,217) using an HIV-specific HRQOL and three symptom status instruments according to the Wilson and Cleary HRQOL model. Multiple stepwise linear regression analysis found that younger age predicted higher sexual function (ΔR(2) = .12, p < .01) and older age predicted greater provider trust (ΔR(2) = .04, p < .01). No significant differences were found in symptom status or the other seven HRQOL dimensions. Although older HIV-positive persons reported more comorbidities, they did not report more symptoms., (Copyright © 2011 Elsevier Inc. All rights reserved.)

This article investigates change and continuity in anxieties about shopping during the first half of the twentieth century in Egypt to argue that department stores and their salesclerks became critical sites for enacting and challenging new notions of sexuality and citizenship. Retail innovations, such as commission pay, display, free entry, and large commercial staffs, became understood as sexual and moral problems because department stores blurred the boundaries between classes and were public spaces where unrelated men and women could mix. These concerns about sexuality in the 1920s were recycled and amplified in the late 1940s and early 1950s when salesclerks again came under scrutiny during debates over citizenship and ethnicity. I argue that the particular way this latter debate was barnacled by the concerns of the 1920s helped to delineate the broader society's reaction to the challenges of defining Egyptian nationality.

Background: A greater number of older adults now live with coronary heart disease (CHD). This poses a significant public health problem, because older adults are at high risk for CHD-related mortality and morbidity. Overwhelming data support the benefits of cardiac rehabilitation for secondary prevention, yet only a small portion of eligible older adults receive it., Methods and Results: Whereas many studies examined factors that affect the use of cardiac rehabilitation among older adults, few interventions aimed to improve their cardiac rehabilitation participation rates. A substantial body of evidence indicates that an individual's illness perceptions play a pivotal role in health behavior, and may be a promising target for intervention. Drawing from the theoretic and empiric findings of others, a self-regulatory model is proposed that explicates how CHD perceptions of older adults may influence participation in cardiac rehabilitation., Conclusion: The model may provide a useful guide for the development of effective interventions tailored to older adults., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Thirteen to 20% of lung cancer patients continue to smoke after diagnosis. Guided by Self-regulation Theory, the purpose of this study was to examine illness perceptions over time in a sample of lung cancer patients. This prospective 1-group descriptive longitudinal design study included participants 18 years or older, with a lung cancer diagnosis within the past 60 days who self-reported smoking within the past 7 days. At baseline, patients completed a sociodemographics and tobacco use history questionnaire. The Illness Perception Questionnaire-Revised (IPQ-R) was repeated at 3 time points (baseline, 2-4 weeks, and 6 months). Fifty-two participants provided data for the IPQ-R at baseline, 47 at 2 to 4 weeks, and 29 at 6 months. Differences between mean scores for each illness representation attribute of the IPQ-R at repeated time points were calculated by within-subjects repeated-measures analysis of variance and Wilcoxon Signed-Rank Tests. Identity (baseline vs 2-4 weeks: P = .026; baseline vs 6 months: P = .005) and acute/chronic timeline (P = .018) mean scores significantly increased over time; personal and treatment control mean scores significantly decreased over time (P = .007 and P = .047, respectively). Understanding the context in which a patient perceives disease and smoking behavior may contribute to developing interventions that influence behavior change.

As many as 50-70% of persons infected with HIV are current smokers. Compelling evidence concerning the risks of cigarette smoking to persons living with HIV urges the inclusion of smoking treatment protocols in contemporary models of HIV care. Yet in spite of growing awareness of this problem, persons living with HIV are not being effectively treated for tobacco use. To further an understanding of contributing factors and define directions for evidenced-based intervention, factors associated with smoking behavior among persons living with HIV are examined.

Persons living with HIV/AIDS use self-care for symptom management. This study assesses the use of marijuana as a symptom management approach for six common symptoms for persons living with HIV/AIDS--anxiety, depression, fatigue, diarrhea, nausea, and peripheral neuropathy. This sub-analysis of the efficacy of a symptom management manual encompasses the experiences of participants from sites in the U.S., Africa, and Puerto Rico. Baseline data are analyzed to examine differences in the use and efficacy of marijuana as compared with prescribed and over-the-counter medications as well as the impact on adherence and quality of life.

Throughout the history of the HIV epidemic, HIV-positive patients with relatively high CD4 counts and no clinical features of opportunistic infections have been classified as "asymptomatic" by definition and treatment guidelines. This classification, however, does not take into consideration the array of symptoms that an HIV-positive person can experience long before progressing to AIDS. This short report describes two international multi-site studies conducted in 2003-2005 and 2005-2007. The results from the studies show that HIV-positive people may experience symptoms throughout the trajectory of their disease, regardless of CD4 count or classification. Providers should discuss symptoms and symptom management with their clients at all stages of the disease.

Fatigue has been identified as a key complaint among patients with HIV/AIDS. Although having more than one disease is expected to increase symptom severity, this relationship has not been explored extensively. We investigated differences in fatigue severity together with the impact of demographic factors and the number of comorbidities and symptoms among patients with and those without comorbidities at 18 international clinical and community sites. Specific comorbidities and the number of symptoms associated with increased fatigue severity. Only by distinguishing fatigue as to its causes and patterns will health care providers be able to intervene specifically and thus more effectively.

The purpose of this study was to assess personal beliefs about the causes and meaning of having HIV disease and personal beliefs about medication adherence in persons living in rural southeastern North Carolina. Of the total sample of 34 participants, 29 (85%) were African American. The sample included 21 men (62%) and 13 women (38%), with a self-reported mean CD4 count of 499.38 (SD = 377.69) and a mean duration of HIV of 8.0 years. The majority of participants held beliefs that HIV was a serious and chronic condition and that the disease could be controlled by HIV therapies. Participants offered disparate views about whether or not the course of HIV disease was amenable to personal control. The persons who held the belief that the cause of HIV/AIDS was because of chance/bad luck (p = .03) or God's will (p < .001) were also most likely to believe that the progression of their HIV disease depended on chance or fate. The respondents currently taking HIV medication were also more likely to believe that HIV was caused by chance or bad luck (p = .038) or God's will (p = .016). The results reflect the important role of spirituality on self- regulation of illness and treatment in the rural southern culture.

Objective: To determine whether proactive telephone support improves adherence to antiretroviral therapy (ART) and clinical outcomes when compared to standard care., Methods: A multisite, randomized controlled trial (RCT) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group (ACTG) 384. Subjects received standard clinic-based patient education (SC) or SC plus structured proactive telephone calls. The customized calls were conducted from a central site over 16 weeks by trained registered nurses. Outcome measures (collected over 64 weeks) included an ACTG adherence questionnaire and 384 study endpoints., Results: For the primary endpoint, self-reported adherence, a significantly better overall treatment effect was observed in the telephone group (P = 0.023). In a post hoc analysis, composite adherence scores, taken as the first 2 factor scores from a principal components analysis, also found significant intervention benefit (P = 0.023 and 0.019 respectively). For the 384 primary study endpoint, time to regimen failure, the Kaplan-Meier survival curve for the telephone group remained above the SC group at weeks 20 to 64; a Cox proportional hazard model that controlled for baseline RNA stratification, CD4, gender, age, race/ethnicity, and randomized ART treatment arm suggested the telephone group tended to have a lower risk for failure (hazard ratio = 0.68; 95% confidence interval: 0.38 to 1.23)., Conclusions: Findings indicate that customized, proactive telephone calls have good potential to improve long-term adherence behavior and clinical outcomes.

Background/objective: The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire is used extensively, but investigators frequently only use the first item of the questionnaire (4-day recall)., Design/methods: A secondary analysis was conducted to (1) estimate the validity and reliability of each of the 5 scale items and (2) compare the approach commonly used to summarize adherence data collected with the instrument (average 4-day recall) with alternate approaches derived using principal component (PC) analysis and the full questionnaire. We hypothesized that an estimate of adherence taking all items of the questionnaire into account would provide a stronger measure of adherence., Results: Logistic regression analyses showed that the first PC identified (PC1) was significantly correlated with plasma HIV RNA outcome (P < 0.0001 for ACTG 370 data and P = 0.006 for ACTG 398 data) and correlated with plasma HIV RNA better than average 4-day recall. An adherence index formulated using weights of PC1 showed substantially greater variability in the range of adherence scores in comparison to average 4-day adherence recall alone. PC1 compared favorably with 2 indices derived from medication event monitoring system data as well., Conclusions: Findings indicate that a superior assessment of antiretroviral adherence may be obtained with the ACTG Adherence Questionnaire by using the method employed in this analysis.

Compliance is the extent to which a patient follows the prescribed regimen. Here we investigate the statistical properties of two popular measures of compliance - percentage of compliant days and percentage of doses taken. We use a stationary Markov chain to model the dependence structure of successive data points for each subject. We illustrate our model using discrete compliance data collected from an AIDS Clinical Trial Group study (ACTG 398). We check the model assumptions and evaluate the small sample as well as large sample properties of our estimators. We show that ignoring the within-subject dependence will usually underestimate the standard errors of the estimates of these compliance measures. Our model allows the application of meta-analytic approaches to assess the variation across subjects in these compliance indices and changes in them due to intervention., (((c) 2007 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim).)

The objective of this study was to explore the association of gender to use of prayer as a self-care strategy for managing the HIV-related symptoms of fatigue, nausea, depression, and anxiety among African American men and women who are HIV-seropositive. To accomplish this, data were determined using convenience sampling from a sample of 448 African American men and women from the United States who were participants in a national study on self-care symptom management of HIV/AIDS. Chi-square analyses were used to examine the potential relationships between gender and the use of prayer for managing the four symptoms. The mean age of the sample was 42.69 +/- 7.93 years (range, 20-66). Results showed the following gender differences in the use of prayer as a self-care strategy: fatigue-men 46% (n = 62), women 54% (n = 74); nausea-men 52% (n = 33), women 48% (n = 30); depression-men 55% (n = 90), women 45% (n = 73); and anxiety-men 77% (n = 83), women 87% (n = 73). Chi-square analyses determined that significant differences exist between African American men and women in the frequency of the use of prayer for managing HIV-related fatigue (chi(2) = 14.81, 1 df, p = .000), nausea (chi(2) = 4.10, 1 df, p =.043), and depression (chi(2) = 5.21, 1 df, p = .022). There was no gender difference in the use of prayer to manage anxiety. Prayer was reported as a self-care strategy by over 50% of the respondents for three of the four symptoms and was rated highly efficacious. The authors conclude that the African American men and women differed in their selection of prayer as a self-care strategy for managing HIV-related depression, fatigue, and nausea. A higher proportion of women than men used prayer to manage fatigue, and more men than women reported using prayer to manage nausea and depression.

Data were analyzed from an ethnically diverse convenience sample comprising 1071 adults participating in a multisite study. Older African Americans, Hispanics, and females were more likely to use prayer as a complementary health strategy for HIV-related anxiety, depression, fatigue, and nausea. Implications for future studies are discussed.

HIV-related morbidity and mortality have been dramatically improved in populations treated with combination antiretroviral therapy. Although it is widely recognized that adherence to the antiretroviral medication regimens is vital to treatment success, rates of adherence to the regimens are often poor. There is a large body of research exploring the problem of adherence to antiretroviral medications. The literature is, to date, dominated by reports identifying factors that are predictive or associated with antiretroviral adherence. Adherence is increasingly understood as a dynamic behavior influenced by a matrix of interrelated factors that change over time. Preliminary reports suggest varying degrees of success with strategies designed to improve adherence. Multifaceted strategies appear to be the most promising; however, there are few controlled studies substantiating the effectiveness of these approaches and the mechanisms by which the interventions promote adherence are not well understood. More well powered, rigorously evaluated antiretroviral adherence intervention trials are urgently needed. Further, problems in the field exist because of limitations in the available adherence measures. This paper provides a comprehensive review and analysis of the state-of-the-science of this body of work. Despite substantial attention to antiretroviral adherence in recent years, there remain significant gaps in our understanding., (Copyright 2004 Bentham Science Publishers Ltd.)

Focus group interviews were conducted with 13 men living with HIV (mean age = 44.7) to explore their beliefs about cigarette smoking and HIV. Interview data were audiotaped, transcribed verbatim, and systematically analyzed using inductive techniques. Participants believed cigarette smoking provides a number of benefits to persons living with HIV. Although participants acknowledged that smoking has disadvantages, smokers generally discounted health risks, noting how it improves their sense of well-being and reasoning that they would not live long enough to suffer its consequences. Although smoking is a risk factor for HIV-related morbidity and mortality, rates of smoking are high among men living with HIV. Research completed with other population groups finds beliefs are significant in explaining variance in smoking behavior change. Smoking-cessation programs targeting HIV-positive men may be more successful if illness-specific belief systems are taken into account. Additional study is warranted to substantiate the effectiveness of this approach.

It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Beliefs about antiretroviral therapy and psychosocial characteristics of HIV-positive persons naive to therapy may influence early experience with antiretroviral medication adherence and therefore could be important when designing programs to improve adherence to antiretroviral therapy. As part of a multicenter AIDS Clinical Trial Group (ACTG 384) study, 980 antiretroviral-naive subjects (82% male, 47% White, median age 36 years, and median CD4 cell count 278 cells/mm3) completed a self-administered questionnaire prior to random treatment assignment of initial antiretroviral medications. Measures of symptom distress, general health and well-being, and personal and situational factors including demographic characteristics, social support, self-efficacy, depression, stress, and current adherence to (nonantiretroviral) medications were recorded. Associations among variables were explored using correlation and regression analyses. Beliefs about the importance of antiretroviral adherence and ability to take antiretroviral medications as directed (adherence self-efficacy) were generally positive. Fifty-six percent of the participants were "extremely sure" of their ability to take all medications as directed and 48% were "extremely sure" that antiretroviral nonadherence would cause resistance, but only 37% were as sure that antiretroviral therapy would benefit their health. Less-positive beliefs about antiretroviral therapy adherence were associated with greater stress, depression, and symptom distress. More-positive beliefs about antiretroviral therapy adherence were associated with better scores on health perception, functional health, social-emotional-cognitive function, social support, role function, younger age, and higher education (r values = 0.09-0.24, all p < .001). Among the subset of 325 participants reporting current use of medications (nonantiretrovirals) during the prior month, depression was the strongest correlate of nonadherence ( r = 0.33, p < .001). The most common reasons for nonadherence to the medications were "simply forgot" (33%), "away from home" (27%), and "busy" (26%). In conclusion, in a large, multicenter survey, personal and situational factors, such as depression, stress, and lower education, were associated with less certainty about the potential for antiretroviral therapy effectiveness and one's perceived ability to adhere to therapy. Findings from these analyses suggest a role for baseline screening for adherence predictors and focused interventions to address modifiable factors placing persons at high risk for poor adherence prior to antiretroviral treatment initiation.

Objective: Prior studies of quality of life among cardiac patients have examined mostly men. This study evaluated gender differences in quality of life and examined the degree to which social support was associated with quality of life., Methods: A sample of 536 patients (35% women) was recruited during a 14-month period from the inpatient cardiology service of a University-based hospital. Participants completed assessments at baseline and at 3-month intervals over the subsequent 12 months, for a total of 5 assessments. Measures at each assessment included quality of life [Mental Component Score (MCS) and Physical Component Score (PCS) from the Medical Outcomes Study--Short Form 36] and social support [Interpersonal Support Evaluation List--Short Form]., Results: A total of 410 patients completed the baseline assessment and at least one follow-up, and were included in the data analyses. Linear mixed effects modeling of the MCS score revealed a significant effect of gender (p =.028) and time (p <.001), as well as a significant interaction of gender by social support (p =.009). Modeling of the PCS revealed a significant effect of gender (p =.010) and time (p <.001)., Conclusions: Women with cardiac disease indicated significantly lower quality of life than men with cardiac disease over the course of a 12-month longitudinal follow-up. Social support, especially a sense of belonging or companionship, was significantly associated with emotional quality of life (MCS) among women. Strategies to increase social support may be important for health and well-being of women with cardiac disease.

Reliable data on the incidence and severity of nausea accompanying combination antiretroviral therapies is lacking. A prospective time series design was used to assess the rate, severity, and distress of nausea in a cohort of 75 HIV-positive patients who were beginning or changing a combination of two or more antiretroviral medications. Data were collected via telephone at weekly intervals for 12 weeks. The rate of nausea across regimens was greatest at Week 1 (39%) and declined progressively over time. By Week 12, the rate of nausea was only 5%. Severity of nausea was ranked as moderate or severe by a substantial proportion of patients through Week 10; however, nausea severity and distress were also found to diminish over time. The nausea associated with combination antiretroviral therapy is quite common and may adversely affect medication adherence. Findings indicate that clinicians should consider initiating interventions for management of antiretroviral-related nausea at baseline.

The effects of diflunisal, a nonacetylated difluorinated salicylate, on platelet function were compared with those of aspirin and placebo. In a randomized, double-blind trial, normal subjects were given diflunisal, 250, 500, or 1,000 mg twice daily; aspirin, 650 or 1,300 mg twice daily; or placebo for 8-day periods. Diflunisal, 250 mg, had no effect on platelet function, whereas 500 mg induced minimal inhibition of collagen-induced release of platelet serotonin, and 1,000 mg inhibited platelet malondialdehyde production, moderately prolonged template bleeding times (p = NS), and increased fecal blood loss (p < 0.05). In contrast, aspirin, 650 mg, markedly inhibited collagen-induced platelet aggregation and serotonin release, and 1,300 mg prolonged bleeding time (p < 0.01) and increased fecal blood loss (p < 0.01). The effects of aspirin lasted for up to 5 days, whereas changes induced by diflunisal had returned to baseline 24 hours after the drug was discontinued. We conclude that in doses in the same range as those of aspirin diflunisal inhibits platelet function less., (1983 Pharmacotherapy Publications Inc.)