Correlates of psychological intimate partner violence with HIV care outcomes on patients in HIV care.

BACKGROUND: Among people living with HIV (PLWH), physical intimate partner violence (IPV) is associated with poor virologic, psychiatric, and behavioral outcomes. We examined non-physical, psychological intimate partner violence (psy-IPV) and HIV care outcomes using data from two U.S. consortia. METHODS: We conducted multivariable analyses with robust standard errors to compare patients indicating/not indicating psy-IPV. RESULTS: Among PLWH (n = 5950), 9.5% indicated psy-IPV; these individuals were younger (- 3; 95% CI [- 2,-4], p-value < 0.001), less likely to be on antiretroviral treatment (ART) (0.73 [0.55,0.97], p = 0.03), less adherent to ART (- 4.2 [- 5.9,-2.4], p < 0.001), had higher odds of detectable viral load (1.43 [1.15,1.78], p = 0.001) and depression (2.63 [2.18,3.18], p < 0.001), and greater use of methamphetamines/crystal [2.98 (2.30,3.87),p < 0.001], cocaine/crack [1.57 (1.24,1.99),p < 0.001], illicit opioids [1.56 (1.13,2.16),p = 0.007], and marijuana [1.40 (1.15,1.70), p < 0.001]. CONCLUSION: Psychological IPV, even in the absence of physical or sexual IPV, appears to be associated with HIV care outcomes and should be included in IPV measures integrated into routine HIV care.

Building the Case for Localized Approaches to HIV: Structural Conditions and Health System Capacity to Address the HIV/AIDS Epidemic in Six US Cities.

Since the discovery of the secondary preventive benefits of antiretroviral therapy, national and international governing bodies have called for countries to reach 90% diagnosis, ART engagement and viral suppression among people living with HIV/AIDS. The US HIV epidemic is dispersed primarily across large urban centers, each with different underlying epidemiological and structural features. We selected six US cities, including Atlanta, Baltimore, Los Angeles, Miami, New York, and Seattle, with the objective of demonstrating the breadth of epidemiological and structural differences affecting the HIV/AIDS response across the US. We synthesized current and publicly-available surveillance, legal statutes, entitlement and discretionary funding, and service location data for each city. The vast differences we observed in each domain reinforce disparities in access to HIV treatment and prevention, and necessitate targeted, localized strategies to optimize the limited resources available for each city's HIV/AIDS response.

Correlates of Unknown HIV Status Among MSM Participating in the 2014 American Men's Internet Survey (AMIS).

Increasing serostatus awareness is a key HIV prevention strategy. Despite expanded testing efforts, some men who have sex with men (MSM) remain unaware of their HIV status. This study explored demographic characteristics, sexual identity, sexual role, and behavioral factors associated with unknown HIV status among MSM in the United States. Data from 9170 MSM in the 2014 American Men's Internet Survey were analyzed using logistic regression to identify correlates of unknown HIV status. Young age, race, low education, rural residence, and lack of recent healthcare visits were significantly associated with unknown HIV status. In addition, nondisclosure of one's sexual orientation (OR = 3.70, 95% CI 2.99-4.59) and a self-identified sexual role as "bottom" (OR = 1.45, 95% CI 1.24-1.70) were predictors of unknown HIV status. Post-hoc analysis showed HIV-negative MSM not tested in the last year had fewer self-reported risk behaviors than recent testers, suggesting that repeat testing among MSM may be aligned with individual risk.

HIV rapid testing in substance abuse treatment: implementation following a clinical trial.

The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial, the agency implemented an HIV testing and counseling program. During the trial, a post-trial pilot, and early implementation the agency identified challenges and developed strategies to overcome barriers to adoption of the intervention. Their experience may be instructive for other treatment providers seeking to implement an HIV testing program. Lessons learned encompassed the observed acceptability of testing and counseling to clients, the importance of a "champion" and staff buy-in, the necessity of multiple levels of community and agency support and collaboration, the ability to streamline staff training, the need for a clear chain of command, the need to develop program specific strategies, and the requirement for sufficient funding. An examination of costs indicated that some staff time may not be adequately reimbursed by funding sources for activities such as adapting the intervention, start-up training, ongoing supervision and quality assurance, and overhead costs.

Predicting protected sexual behaviour using the Information-Motivation-Behaviour skills model among adolescent substance abusers in court-ordered treatment.

The Information-Motivation-Behavioural skills model (Fisher & Fisher, 1992) was used to predict condom use among adolescents residing in a court-ordered inpatient substance abuse treatment programme (N = 271; 181 male and 90 female, primarily of minority ethnicity). In a predictive structural equation model, demographic variables, HIV transmission knowledge, and motivational variables of pro-condom norms and attitudes, and perceived susceptibility predicted condom use skills and condom use self-efficacy. Along with the other variables in the model, condom skills and condom self-efficacy were hypothesized to predict condom use over a three-month period. It was found that condom skills were predicted by greater age, pro-condom attitudes and greater perceived susceptibility. Condom self-efficacy was predicted by gender, pro-condom norms and condom attitudes. Condom use was significantly predicted by pro-condom norms and stronger condom self-efficacy. Both condom skills and knowledge did not significantly predict condom use. Significant demographic predictors of condom use included greater age and gender. Results suggest that changing personal attitudes about condoms and reinforcing the power of pro-condom beliefs among significant others will encourage condom use among adolescents who are at high risk for HIV and other STDs.

A randomized controlled clinical trial of a bereavement support group intervention in human immunodeficiency virus type 1-seropositive and -seronegative homosexual men.

BACKGROUND: Bereavement is a severe and frequent stressor among those infected with human immunodeficiency virus type 1 (HIV-1) and those affected by the acquired immunodeficiency syndrome epidemic. This study examined the impact of a research-derived, semistructured, bereavement support group among HIV-1-seropositive and HIV-1-seronegative homosexual men having lost a close friend or intimate partner to the acquired immunodeficiency syndrome within the prior 6 months. METHODS: A total of 166 subjects (97 HIV-1 seropositive; 69 HIV- 1 seronegative) were randomly assigned to groups of homogeneous HIV-1 serostatus or to their respective control group. Subjects were assessed at entry and at 10 weeks with psychosocial questionnaires, a semistructured interview for psychopathology, a medical history and physical examination, urine collection, and phlebotomy. RESULTS: For a composite score of psychological distress and grief as well as the distress component, scores were significantly lower after the intervention by analyses against baseline scores, with and without control variables for other factors affecting distress level. A significant reduction in grief level was found only in the analysis that included control variables. Control subjects showed no significant decrements in overall distress, although a significant decrement in grief level was observed. CONCLUSION: A brief group intervention can significantly reduce overall distress and accelerate grief reduction in a sample of bereaved subjects unselected for psychopathology or at high risk for subsequent maladjustment.

Mild cognitive impairment and risk of mortality in HIV-1 infection.

HIV-1-associated cognitive impairment has only been preliminarily investigated for associations with mortality. The authors examined 119 HIV-1-positive homosexual men (asymptomatic: n = 96; early symptomatic: n = 23). At follow-up (to 3.5 years), there were 105 survivors and 14 nonsurvivors. Those at the 25th percentile in response speeds and in long-term memory retrieval accuracy were at 6.4 (P < 0.02) and 3.5 (P < 0.05) times increased mortality risk, respectively, of those at the 75th percentile--independent of baseline CDC clinical stage, CD4 cell count, hemoglobin level, antiretroviral and prophylactic medication use, and sociodemographics. Cognitive impairment should be identified early--for maximization of both functional status and survival time.

Plasma pyridoxine deficiency is related to increased psychological distress in recently bereaved homosexual men.

OBJECTIVE: Previous research has demonstrated that a theoretical model including measures of life stressors, social support, and coping style significantly predicts psychological distress. This study tested plasma pyridoxine (vitamin B6) deficiency status as a predictor of overall psychological distress and specific mood states in this model, controlling for HIV-1 serostatus. METHOD: Subjects included HIV-1+ (N = 76) and HIV-1- (N = 58) recently bereaved homosexual men. At baseline, subjects completed a battery of psychosocial questionnaires, together with a physical examination and venipuncture. The Profile of Mood States (POMS) provided measures of overall psychological distress as well as specific mood states. Pyridoxine deficiency status (a categorical measure of deficient vs. adequate status) was determined with a bioassay of erythrocyte aspartate aminotransferase activity. RESULTS: Pyridoxine deficiency was a significant predictor of increased overall psychological distress in this model, controlling for life stressors, social support, coping style, and HIV-1 serostatus. In post hoc analyses of specific mood state effects, pyridoxine deficiency status was significantly associated with increases in depressed, fatigued, and confused mood levels, but not with those of anxiety, anger, or vigor. DISCUSSION: These findings suggest that adequate pyridoxine status may be necessary to avert psychological distress in the setting of bereavement. Inasmuch as pyridoxine is a cofactor for 5-hydroxytryptophan decarboxylase--an enzyme in the biosynthesis pathway of serotonin--serotonin level in the brain is implicated as the mediating factor.

A bereavement support group intervention is longitudinally associated with salutary effects on the CD4 cell count and number of physician visits.

A randomized, controlled, clinical trial was conducted to examine the impact of a semistructured, 10-week, once weekly, 90-min/session bereavement support group intervention on immunological, neuroendocrine, and clinical health status in human immunodeficiency virus type 1-seropositive (HIV-1+) and HIV-1-seronegative (HIV-1-) homosexual men, compared to a standard of care control condition. A total of 119 homosexual men (74 HIV-1+ and 45 HIV-1-) were assessed at baseline, 10 weeks, and 6 months follow-up. At the 6-month follow-up assessment, the intervention groups exhibited significant beneficial effects compared to controls on changes in CD4 cell, total T-lymphocyte, and total lymphocyte counts, when baseline levels, antiretroviral medication use, CDC stage of disease, and other potentially confounding factors were accounted for. There was no statistically significant effect on the CD4/CD8 ratio or on the CD8 cell count. The effect on CD4 cell count was associated with group attendance and with changes in plasma cortisol level. Plasma cortisol levels decreased significantly among intervention subjects, compared to controls. A significantly reduced number of health care visits over the 6-month follow-up period among the intervention subjects supported the clinical relevance of the immunological changes observed for both HIV-1+ and HIV-1- individuals. These results indicate that behavioral interventions may have salutary immunological and clinical health effects following bereavement among HIV-1-infected individuals. The effect in HIV-1- individuals suggests that this bereavement support group intervention might have similar salutary effects in the general population. Potential effects of such interventions on clinical HIV disease progression are of interest and should be studied.

Randomized double-blind placebo-controlled trial of peptide T for HIV-associated cognitive impairment.

BACKGROUND: Cognitive impairment is a common consequence of human immunodeficiency virus (HIV) infection, and dementia is one of the diseases that defines the acquired immunodeficiency syndrome. Peptide T (d-ala-peptide-T-amide) has been reported to block the binding of gp120 to brain tissue and to protect neurons from the toxic effects of gp120 in vitro. In pilot studies, administration of peptide T to HIV-positive patients with cognitive impairment was associated with improvement in cognition and constitutional symptoms. OBJECTIVE: To determine whether the intranasal administration of peptide T would improve cognitive function of HIV-positive patients with cognitive impairment. PATIENTS AND METHODS: This was a 3-site, double-blind, placebo-controlled trial of peptide T given intranasally at a dosage of 2 mg 3 times a day for 6 months. Participants were HIV-seropositive persons with evidence of cognitive deficits on a screening test battery. Concomitant antiretroviral therapy was allowed. Randomization to the 2 study arms was balanced according to several stratification variables, such as CD4+ cell count, severity of cognitive impairment, and antiretroviral therapy at study entry. A comprehensive neuropsychological (NP) battery, which yielded 23 scores, was administered at baseline and the study end point. The primary outcome measure was a global NP score derived from the 23 standardized scores. The efficacy end point was the change in NP score at 6 months compared with baseline. Secondary efficacy measures were 7 cognitive domain scores and deficit scores of global and domain performance. The patients who completed the baseline and final NP evaluations (after at least 4 months in the randomized treatment arm) were included in the efficacy analyses. Additional analyses were conducted on subgroups of patients according to the CD4+ count and baseline NP deficit. The incidence of NP improvement in the 2 treatment arms was also compared. RESULTS: There was no statistically significant difference between the peptide T and placebo groups on the global NP change score, the individual domains, or the deficit scores. Because of an imbalance in the baseline CD4+ cell count between treatment arms, analyses were also adjusted for this variable. These CD4+-adjusted analyses suggested (P = .07; analysis of covariance [ANCOVA]) a greater improvement in the peptide T group. Subgroup analyses indicated a treatment effect for patients whose CD4 cell count was above 0.200 x 10(9)/L (200 cells/microL) at baseline. Moreover, peptide T treatment was associated with overall cognitive improvement in patients with baseline global deficit scores of at least 0.5, while overall deterioration was more common among the placebo group (P = .02; Mantel-Haenszel chi(2) test). CONCLUSIONS: Peptide T was not significantly different from placebo on the study primary end points. However, additional analyses indicated that peptide T may be associated with improved performance in the subgroup of patients with more evident cognitive impairment (ie, NP global deficit score > or = 0.5) or with relatively preserved immunological status (ie, CD4+ cell count > 0.200 x 10(9)/L).

HIV-1 proviral DNA load across neuroanatomic regions of individuals with evidence for HIV-1-associated dementia.

A definitive relation between HIV-1 load and the clinical diagnosis of HIV-1-associated dementia (HAD) has not yet been established. Knowledge of the neuroanatomic distribution of HIV-1 load in the brain of individuals with HAD and HIV-1 encephalitis may facilitate elucidation of this relation. Nine individuals with AIDS were analyzed postmortem by three independent methods with each assessment performed blinded to the others: 1) a neuropsychiatric review of clinical records for evidence of possible HAD, 2) HIV-1 DNA load determination by quantitative polymerase chain reaction (PCR) across several neuroanatomic regions, and 3) a pathologic examination for diagnosis of HIV-1 encephalitis by immunohistochemical techniques. Of eight AIDS cases with clinical records sufficient for neuropsychiatric review, seven were shown to have evidence for HAD. HIV-1 DNA was detected and quantified in specimens from all of the medial temporal lobe regions analyzed but was not detectable in the frontal lobe at the same level of sensitivity in two of these cases (<1 per 1000 cellular genomes). HIV-1 DNA load in the medial temporal lobe region was significantly larger than that in the frontal lobe. Only four of seven cases with evidence for HAD were also diagnosed with HIV-1 encephalitis.

A rapid method for comparative quantitative polymerase chain reaction of HIV-1 proviral DNA extracted from cryopreserved brain tissues.

The quantitative polymerase chain reaction (PCR) method devised by Fujimura and Bockstahler (1995) was modified for rapid determination of distribution of HIV-1 proviral DNA load in AIDS brains. It was used for analysis of an association with HIV-1 associated dementia and HIV-1 encephalitis (Fujimura et al., 1997). The method has wider applicability for comparative studies of viral DNA load based on PCR amplification. The method is applicable under conditions where target DNA and its PCR-amplified product increase proportionally. An equation was derived to obtain the number of copies of HIV-1 DNA per cellular genome from the amount of PCR amplified product of a tissue specimen DNA. The equalizing constant is the reciprocal of the slope of the amplification of the HIV-1 proviral DNA sequence of the standard cellular DNA included in each experiment. The intercept of the equation is zero.

Psychological distress in HIV-1 disease in relationship to hypocholesterolemia.

OBJECTIVE: Altered levels of serum cholesterol, which are prevalent in early HIV-1 infection, have been associated with disturbances in mood state and behavior. The objective of this study was to evaluate the relationship of serum cholesterol status and psychological distress in HIV-1 seropositive and seronegative men. METHOD: The association between serum cholesterol level and psychological distress, measured with the Profile of Mood States (POMS), was examined in 169 individuals (117 HIV-1 seropositive and 52 seronegative homosexual men), controlling for negative life events, social support, coping style, and HIV-1 serostatus. RESULTS: Individuals with hypocholesterolemia (serum cholesterol levels < 150 mg/dL), exhibited significantly higher levels of distress, relative to individuals with values of cholesterol > 150 mg/dL (p = 0.01). HIV-1 seropositive men had significantly lower cholesterol levels (p = 0.0001) and higher levels of distress than the seronegative men (p = 0.03). A significant interaction between negative life events and cholesterol status was demonstrated as well (p = 0.04). CONCLUSIONS: Hypocholesterolemia appears to be associated with increased psychological distress. Whereas the causal direction of the cholesterol-distress association cannot be specified, our results suggest that HIV-1 infected men with low cholesterol levels may benefit from being monitored for changes in distress level, so that appropriate psychosocial intervention can be instituted, as necessary.

Bereavement is associated with time-dependent decrements in cellular immune function in asymptomatic human immunodeficiency virus type 1-seropositive homosexual men.

Seventy-nine human immunodeficiency virus type 1 (HIV-1)-seropositive homosexual men participating in a longitudinal study of HIV-1 infection were assessed twice, 6 months apart, to investigate associations between bereavement and cellular immune function. Subjects were assessed by using a theory-driven model comprising life stressors, social support and coping style, and control variables. Natural killer cell cytotoxicity was decreased among the bereaved at both times. Lymphocyte proliferative response to phytohemagglutinin was decreased among the bereaved at the second time point but not at the first. These functional immune decrements are associated with increased neuroendocrine responses of the sympathetic adrenomeduallary system as well as the limbic-hypothalamic-pituitary-adrenal axis. Implications for differential neuroendocrine responses over time are discussed. Active coping style was independently and positively related to both immune measures. The results imply that a bereavement support group intervention merits investigation for an effect on immunological measures and clinical progression of HIV-1 infection as well as grief resolution.

Elevated IgE level in relationship to nutritional status and immune parameters in early human immunodeficiency virus-1 disease.

Elevation of IgE has been associated with T-cell dysregulation and with the occurrence of opportunistic infections in patients with acquired immunodeficiency syndrome. The precise cause of IgE overproduction during the early stages of human immunodeficiency virus (HIV)-1 disease, however, has not been established. In light of reports demonstrating that IgE production may be affected by vitamin E levels in an animal model, we evaluated nutritional status in relationship to plasma IgE levels and immune parameters in 100 asymptomatic HIV-1-seropositive and 42 HIV-1-seronegative homosexual men. Approximately 18% of the HIV-1-seropositive population demonstrated biochemical evidence of plasma vitamin E deficiency (< 5 micrograms/ml). Subsequent analysis of available samples indicated a dramatic elevation of IgE levels (308 +/- 112 IU/ml) in vitamin E-deficient seropositive subjects (n = 9) as compared with age and CD4-matched HIV-1-seropositive persons with adequate vitamin E levels (n = 16, 118.1 +/- 41.1 IU/ml) and significantly lower levels (59.5 +/- 15.7 IU/ml) in HIV-1-seronegative men (n = 20, p = 0.01). This effect, which was independent of CD4 cell count, did not appear to be influenced by atopic or gastrointestinal parasitic disease. The low plasma vitamin E levels were related at least in part to dietary intake (r = 0.552, p = 0.01), suggesting that supplementation may be warranted in HIV-1-infected persons in whom vitamin E deficiency develops. Analysis of covariance revealed a strong relationship between IgE levels and CD8 cell counts (p < 0.006), and between IgE level and vitamin E deficiency (p < 0.039).(ABSTRACT TRUNCATED AT 250 WORDS)

Impact of vitamin B6 status on psychological distress in a longitudinal study of HIV-1 infection.

OBJECTIVE: Inadequate vitamin B6 status has been associated with altered neuropsychiatric function, possibly through its effect on the metabolism of neurotransmitters, including serotonin (5-HT). The present eighteen month longitudinal study evaluated the relationship between vitamin B6 status and psychological distress in HIV-1 infected individuals, controlling for the influence of negative life events, social support and coping style. METHOD: Biochemical measurements of nutritional status, and dietary intake evaluations were obtained in HIV-1 seropositive homosexual men, (at baseline: CDC Stages II and III, n = 70; Stage IVA, IVC2 n = 18) at six month intervals. Alterations in nutrient status (e.g., vitamin B6 adequate to inadequate; inadequate to adequate), were compared with changes in psychological distress, measured by the Profile of Mood States, using a multiple regression analysis. RESULTS: A significant decline in psychological distress was demonstrated with normalization of vitamin B6 status from inadequate to adequate status (p < 0.02). A decrease in psychological distress was also observed with increased tryptophan intake in subjects who were vitamin B6 adequate (p < 0.02). CONCLUSIONS: Significant effects for the nutritional variables remained even when negative life event stressors, social support, and coping style were controlled, suggesting that vitamin B6 status may be an important co-factor in determining level of psychological distress over time in HIV-1 infected individuals.

Active coping style is associated with natural killer cell cytotoxicity in asymptomatic HIV-1 seropositive homosexual men.

The aim of this study was to examine the hypothesis that a psychosocial model was associated with natural killer cell cytotoxicity (NKCC) in HIV-1 infection. A sample of 62 HIV-1 seropositive homosexual men at CDC stages II and III were given a psychosocial battery assessing life stressors, social support, and coping style. A regression model quantifying these variables along with control variables for alcohol use, substance use and nutritional status was estimated. Active coping style was directly and positively associated with NKCC, and trends toward a negative relationship of life stressors and a buffering effect of social support on lives stressors were also observed. The results suggest that (1) control variables should be included with psychosocial models and that (2) psychosocial factors, especially active coping, may have a deterrent effect on loss of NK cell function. Active coping style may merit a specific focus in future research of life stressors and the immune system.

Life stressors and coping style are associated with immune measures in HIV-1 infection--a preliminary report.

OBJECTIVE: Life stressors and coping style have been associated with alterations in cellular immunity similar to those seen in HIV-1 infection. The interval between infection with HIV-1 and the development of AIDS is lengthy and highly variable. This pilot study investigated whether life stressors and coping style may account for a portion of this variation. METHOD: A sample of eleven asymptomatic HIV-1 seropositive homosexual male volunteers responding to a local advertisement was assessed on life stressors, coping style and cellular phenotypic and functional immune measures--T4 "helper" cell/T8 "suppressor" cell ratio, T4 cell count, total lymphocyte count, and natural killer cell cytotoxicity. RESULTS: Significant associations were observed for both major life stressor impact over the previous year and passive coping style use with the total lymphocyte count; higher life stressor impact and passive coping style use were associated with lower total lymphocyte counts. Similarly, a trend in the same direction was found for the relationship of these two measures with the count of T4 cells, which are directly infected and killed by HIV-1. CONCLUSIONS: It is well documented that decrements in T4 cell and total lymphocyte counts are powerful predictors of subsequent clinical progression to AIDS. These preliminary findings suggest that life stressors and coping style may also be predictors of the development of AIDS.

A stress-moderator model of distress in early HIV-1 infection: concurrent analysis of life events, hardiness and social support.

A stress moderator framework was employed to investigate the relationship of negative life events, hardiness and social support to psychological distress among 67 asymptomatic HIV-1 seropositive gay males. Both main effects and stress moderator (interaction) models were evaluated. Main effects were found for negative life events and social support but not hardiness (either as commitment or overall hardiness); no moderator effects emerged. Results were the same whether events were quantified as negative impact or as number of events, and were in the predicted direction--life events associated with greater distress, social support with less distress. The present study replicates for early HIV-1 infection findings obtained in non-HIV-infected samples about the influence on psychological distress of negative life events and social support. Methodological limitations, possible explanations for the absence of stress moderator effects, and clinical implications of the findings are discussed.

Zidovudine-associated adverse reactions in a longitudinal study of asymptomatic HIV-1-infected homosexual males.

Chemotherapeutic regimens frequently interact with and may influence nutritional factors. To determine the possible effects of zidovudine (ZDV) treatment on nutrient status, this study examined and compared the nutritional, immunological, and hematological status of asymptomatic, CDC stage III, HIV-1-seropositive males (n = 15) provided with ZDV (500-1,200 mg/day) and 22 nontreated, CD4-matched HIV-1-seropositive subjects. Prior to ZDV administration, hematological and plasma nutrient levels were similar in both groups. Following ZDV treatment, drug-treated subjects demonstrated alterations in hematological and nutritional parameters. A large proportion of the ZDV-treated participants exhibited decreased levels of zinc and copper along with a significant increase in red cell folate. The level of plasma zinc appeared to be particularly important in maintaining immune function in the ZDV-treated group. Whereas ZDV-treated subjects with adequate zinc levels displayed a significant increase in the response of peripheral blood lymphocytes to mitogens, this enhancement was not demonstrated in zinc-deficient, ZDV-treated participants or in untreated individuals whose lymphocyte response significantly declined over time, despite adeqaute zinc status. The findings of this study reveal a zidovudine-induced effect on nutritional parameters, indicating the importance of monitoring nutritional status with drug therapeutic regimens.