Nurse-Led Strategy to Improve Blood Pressure and Cholesterol Level Among People With HIV: A Randomized Clinical Trial.

Importance: Despite higher atherosclerotic cardiovascular disease (ASCVD) risk, people with HIV (PWH) experience unique barriers to ASCVD prevention, such as changing models of HIV primary care. Objective: To test whether a multicomponent nurse-led strategy would improve systolic blood pressure (SBP) and non-high-density lipoprotein (HDL) cholesterol level in a diverse population of PWH receiving antiretroviral therapy (ART). Design, Setting, and Participants: This randomized clinical trial enrolled PWH at 3 academic HIV clinics in the US from September 2019 to January 2022 and conducted follow-up for 12 months until January 2023. Included patients were 18 years or older and had a confirmed HIV diagnosis, an HIV-1 viral load less than 200 copies/mL, and both hypertension and hypercholesterolemia. Participants were stratified by trial site and randomized 1:1 to either the multicomponent EXTRA-CVD (A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention) intervention group or the control group. Primary analyses were conducted according to the intention-to-treat principle. Intervention: The EXTRA-CVD group received home BP monitoring guidance and BP and cholesterol management from a dedicated prevention nurse at 4 in-person visits (baseline and 4, 8, and 12 months) and frequent telephone check-ins up to every 2 weeks as needed. The control group received general prevention education sessions from the prevention nurse at each of the 4 in-person visits. Main Outcomes and Measures: Study-measured SBP was the primary outcome, and non-HDL cholesterol level was the secondary outcome. Measurements were taken over 12 months and assessed by linear mixed models. Prespecified moderators tested were sex at birth, baseline ASCVD risk, and trial site. Results: A total of 297 PWH were randomized to the EXTRA-CVD arm (n = 149) or control arm (n = 148). Participants had a median (IQR) age of 59.0 (53.0-65.0) years and included 234 males (78.8%). Baseline mean (SD) SBP was 135.0 (18.8) mm Hg and non-HDL cholesterol level was 139.9 (44.6) mg/dL. At 12 months, participants in the EXTRA-CVD arm had a clinically significant 4.2-mm Hg (95% CI, 0.3-8.2 mm Hg; P = .04) lower SBP and 16.9-mg/dL (95% CI, 8.6-25.2 mg/dL; P < .001) lower non-HDL cholesterol level compared with participants in the control arm. There was a clinically meaningful but not statistically significant difference in SBP effect in females compared with males (11.8-mm Hg greater difference at 4 months, 9.6 mm Hg at 8 months, and 5.9 mm Hg at 12 months; overall joint test P = .06). Conclusions and Relevance: Results of this trial indicate that the EXTRA-CVD strategy effectively reduced BP and cholesterol level over 12 months and should inform future implementation of multifaceted ASCVD prevention programs for PWH. Trial Registration: ClinicalTrials.gov Identifier: NCT03643705.

Evaluation of an emergency department opt-out provider-driven HIV and syphilis screening and linkage-to-care program.

OBJECTIVE: While the effectiveness of emergency departments (ED) in screening for HIV and syphilis is understood, less is known about dual screening programs. We aim to evaluate the impact of an opt-out provider-initiated HIV and syphilis program on screening, diagnosis, and linkage to care outcomes. METHODS: We performed a retrospective review of patients screened pre (2014-2017) and post (2017-2021) program implementation. Primary outcomes include HIV and syphilis screening, incidence of positive tests, and proportion of patients linked to care. Secondary outcomes included pre-exposure prophylaxis (PrEP) referral and successful linkage rates for HIV-negative syphilis-positive patients. RESULTS: Pre-implementation, 882 HIV tests were performed, of which 22 (2.49%) were new cases and 18 (81.82%) were linked to care; 754 syphilis tests were performed, of which 33 (4.38%) were active infections and 30 (90.91%) were treated. No eligible patients received PrEP referral. Post-implementation, 12,999 HIV tests were performed, of which 73 (0.56%) were new cases and 55 (75.34%) were linked to care; 10,885 syphilis tests were performed, of which 216 (1.98%) were active infections and 188 (87.04%) were treated. 25 (9.09%) eligible patients were referred for PrEP, and four (16.0%) attended their appointment. CONCLUSIONS: Post-implementation, there was a 1373.81% and 1343.63% increase in screening, and a 231.82% and 554.55% increase in positive cases of HIV and syphilis, respectively. Dual screening programs can be successfully implemented within the existing ED framework to increase screening and early detection for HIV and syphilis.

Brief Report: Relationship Between Adiposity and Biomarkers of Aging and Frailty Among Adults Aging With HIV.

BACKGROUND: This study examined the relationships among adiposity, handgrip, physical function, inflammation (ie, senescence-associated secretory phenotype chemokines as biomarkers of aging and frailty), and sex hormones in aging people with HIV. METHODS: This cross-sectional exploratory study included 150 people with HIV aged ≥40 years (67.3% of participants were male). Our measures included (1) body mass index and waist circumference as measures of adiposity; (2) handgrip as a measure of muscle strength; (3) short physical performance battery as a measure of physical function; (4) interleukin-6, tumor necrosis factor alpha receptor II, high sensitivity C-reactive protein, C-X-C motif chemokine 10, and C-X3-C motif chemokine ligand 1 also known as fractalkine as senescence-associated secretory phenotype chemokines; and (5) free testosterone, estradiol, sex hormone-binding globulin, and dehydroepiandrosterone as sex hormones. Quantile regression analyses were used to identify relationships among inflammatory markers and hormones with age, adiposity, handgrip, and physical function. RESULTS: Overall, 74% (n = 111) of participants were classified as overweight or obese and 53.3% (n = 80) presented with abdominal obesity. After controlling for age and sex, body mass index was positively associated with estradiol (ß = 0.043, P < 0.01), and waist circumference was positively associated with high sensitivity C-reactive protein (ß = 2.151, P < 0.01). After controlling for sex, age was positively associated with C-X-C motif chemokine 10 (ß = 0.024, P = 0.03) and tumor necrosis factor alpha receptor II (ß = 2.205, P = 0.01). After controlling for age and sex, short physical performance battery was negatively associated with dehydroepiandrosterone (ß = -0.004, P = 0.01); no statistically significant associations were observed for handgrip. CONCLUSION: Adiposity levels and aging were associated with inflammation (ie, C-X-C motif chemokine 10, tumor necrosis factor alpha receptor II, and high sensitivity C-reactive protein) among people with HIV aged 40 years and older.

Integrating HIV Pre-Exposure Prophylaxis (PrEP) Education During Medical Residency: Training Outcomes and Suggestions for Learning Effectiveness.

Human immunodeficiency virus (HIV) infection is now preventable with pre-exposure prophylaxis (PrEP) drugs, however, barriers to PrEP implementation include primary-care physician (PCP) knowledge-gap and lack of comfort prescribing and managing PrEP. We hypothesized that integrating HIV-PrEP education during medical-residency would help address these problems and developed a 40-minute case-based lecture focused on the 2021 United States Preventative Services Taskforce (USPSTF) oral HIV-PrEP guidelines and integrated this into our residency's core curriculum. We analyzed data from physician-trainees who voluntarily completed a pre- and post-lecture survey measuring HIV-PrEP "knowledge" and "self-assessed readiness to independently initiate and manage PrEP." Independent group analysis was completed via the Mann-Whitney U and Pearson Chi-square 2-sided test with P-value <0.05 deemed significant. Of the total of 189 residents invited to the lecture, 130 (69%) completed the pre-survey while 107 (57%) completed the post-survey. Per knowledge-assessment: the median number of correctly answered questions rose from a pre-lecture baseline of 4/9 (44%) to 8/9 (89%) following the education intervention (P < .001). When asked about comfort initiating and managing HIV-PrEP on their own, 7/130 (5.4%) responded in agreement pre-lecture, but this rose to 55/107 (51.4%) post-lecture (P < .001). Our study revealed PrEP training during residency was effective per stated objectives and may be an important tool to increase PrEP delivery/uptake to achieve the target goals for the National HIV/AIDS Strategy.

Physical activity is associated with adiposity in older adults with HIV in the modern HIV era.

OBJECTIVES: People with HIV (PWH) are aging and are experiencing higher rates of abdominal adiposity. Physical activity is an effective nonpharmacological strategy to reduce adiposity in the general aging population. Yet, the relationship between physical activity and adiposity in people with well controlled HIV is unclear. Our objective was to describe the association between objectively-measured physical activity and abdominal adiposity in PWH. METHODS: As part of the multisite, observational PROSPER-HIV study, virologically suppressed, adult PWH wore an Actigraph accelerometer for 7-10 days and completed duplicate waist and hip circumference measures. Demographic and medical characteristics were abstracted from the CFAR Network of Integrated Clinical Systems dataset. Descriptive statistics and multiple linear regressions were used to analyze the data. RESULTS: On average, our 419 PWH were 58 years of age [interquartile range (IQR): 50, 64], male (77%), Black (54%), and currently taking an integrase inhibitor (78%). PWH completed a mean of 7.06 (±2.74) days of total actigraphy wear time. They took an average of 4905 (3233, 7140) steps per day and engaged in 5.4 h of sedentary time per day. Controlling for age, sex, employment and integrase inhibitor use, the number of steps taken per day was associated with reduced abdominal adiposity ( F  = 3.27; P  < 0.001) and the hours of daily sedentary time was associated with increased abdominal adiposity ( F  = 3.24; P  < 0.001). CONCLUSIONS: Greater physical activity is associated with reduced abdominal adiposity in aging PWH. Future work should investigate how to tailor the amount, type and intensity of physical activity needed to reduce adiposity in PWH taking contemporary HIV medication. REGISTRATION NUMBER: NCT03790501.

A Model for Syphilis Screening in the Emergency Department.

The incidence of syphilis infections is on the rise, particularly among African American men and men who have sex with men, and it is reaching epidemic levels in these communities throughout the United States. Although syphilis is relatively inexpensive to treat and cure and is a predictor for HIV incidence among men and transgender women who have sex with men, rates of co-screening for syphilis are low in the emergency department setting, with a dearth of literature on this topic since the 1990s and early 2000s. In this case study, we describe an operational model for routine syphilis screening implemented in June 2017 at the University Hospitals Cleveland Medical Center in Cleveland, Ohio. We describe the advantages of screening using a reverse testing algorithm rather than the traditional method and the necessity of partnering with the Cleveland Department of Public Health for both diagnostic and follow-up logistics.

SARS-CoV-2 infection in a patient on chronic hydroxychloroquine therapy: Implications for prophylaxis.

People exposed to COVID-19 have a risk of developing disease, and health care workers are at risk at a time when they are badly needed during a health care crisis. Hydroxychloroquine and chloroquine have been used as treatment and are being considered as prophylaxis. Our patient developed COVID-19 while on hydroxychloroquine and although more work is needed, this calls into question the role of these medications as preventive therapy.

Lipid-Lowering Therapy in HIV-Infected Patients: Relationship with Antiretroviral Agents and Impact of Substance-Related Disorders.

BACKGROUND: The use of combination antiretroviral therapy (cART) has significantly decreased the morbidity and mortality associated with human immunodeficiency virus (HIV) infection. Lipid disorders, including lipodystrophy, hypertriglyceridemia, and hypercholesterolemia, remain the most commonly reported metabolic disorders among those treated with long-term cART. Mounting evidence suggests an association between drug abuse and poor glycemic control and diabetes complications. Substance related disorders (SRD) may increase the risk of metabolic syndrome. MATERIALS AND METHODS: The aim of this retrospective cohort study was to examine the relationship between SRD, cART, and lipid-lowering agent use in an HIV infected population. Patients received efavirenz or protease inhibitor-based cART for at least 6 months. Prescription information was retrieved from the medical records. The primary outcome was the use of lipid-lowering agents including statins, fibrates and fish oil. The impact of SRD and cART was assessed on the lipid-lowering agent use. RESULTS: A total of 276 subjects with HIV infection were included, 90 (33%) received lipid-lowering agents, and 31 (34%) had SRD. Smoking was prevalent among subjects with SRD (84 vs 15%, p<0.001). Statins were the mainstay for the management of dyslipidemia (66%), followed by the fibrates (24%), omega-3 fatty acids (5%), nicotinic acid (3%) and the cholesterol absorption inhibitors (3%). Use of statins or fibrates was significantly higher among subjects without SRD than those with (40 vs 23%, p=0.005). The type of cART, including efavirenz and protease inhibitors, appeared to have no significant impact on the use pattern of lipid-lowering agents. Lopinavir/ritonavir (lopinavir/r) was mostly prescribed for subjects with SRD (25 vs 8%, p=0.02). CONCLUSION: Among HIV-infected patients, statins remain the mainstay for the management of dyslipidemia in routine clinical care, followed by fibrates. A significant high risk of metabolic disorders among patients with SRD is implicated by heavy tobacco use and prevalent lopinavir/r-based treatment. Significantly low rate of lipid-lowering agent use in this population underscores the importance of lipid disorder scrutiny and cART treatment optimization for HIV-infected patients with SRD.

A cross-sectional description of age and gender differences in exercise patterns in adults living with HIV.

People living with HIV (PLWH) are living longer and are at greater risk for chronic comorbidities (e.g., cardiovascular disease, cancer) compared to those not living with HIV. Regular, sustained exercise can prevent and/or mitigate the severity of these comorbidities. Our purpose was to describe patterns of planned exercise implemented in the home setting (i.e., free-living exercise) in PLWH by gender and age. PLWH (n = 102) completed a sociodemographic survey and a 7-day exercise diary documenting daily exercise duration, frequency, and intensity. Women exercised an average of 2.4 (interquartile range [IQR] 0.5-6.0) hours per week compared to men, who exercised 3.5 (IQR 0.5-7.5) hours per week (p = .18). This relationship was particularly evident during middle adulthood for women versus for men (p = .05). PLWH exercised regularly but at less than recommended levels. This is among the first evidence describing free-living exercise patterns of PLWH.

Age, stress, and isolation in older adults living with HIV.

People living with HIV (PLWH) have increasingly longer life spans. This age group faces different challenges than younger PLWH, which may include increased stress and social isolation. The purpose of this study was to determine whether the age and sex of PLWH are associated with measures of physiologic stress, perceived stress, and social isolation. In this cross-sectional study, we enrolled 102 PLWH equally into four groups divided by age (younger or older than 50 years) and gender. Participants completed well-validated survey measurements of stress and isolation, and their heart rate variability over 60 minutes was measured by Holter monitor. The mean (SD) Perceived Stress Scale score was 17.4 (6.94), mean Visual Analog Stress Scale score was 3.51 (2.79), and mean Hawthorne Friendship Scale score, a measure of social isolation, was 17.03 (4.84). Mean heart rate variability expressed as the SD of successive N-N intervals was 65.47 (31.16) msec. In multivariable regression models that controlled for selected demographic variables, there was no relationship between the Perceived Stress Scale and age (coefficient = -0.09, p =-0.23) or female gender (coefficient = -0.12, p = 0.93); however, there was a modest relationship between female gender and stress using the Visual Analog Stress Scale (coefficient = 1.24, p = 0.05). Perceived Stress was negatively associated with the Hawthorne Friendship score (coefficient = -0.34, p = 0.05). Hawthorne Friendship score was positively associated with younger age (coefficient = 0.11, p = 0.02). Age was the only independent predictor of physiologic stress as measured by heart rate variability (coefficient = -1.3, p < 0.01). Our findings suggest that younger PLWH may experience more social isolation; however, age-related changes in heart rate variability do not appear to be related to perceived stress or social isolation. Future longitudinal research is required to more thoroughly understand this relationship and its impact on the health of PLWH.

Effects of HIV and antiretroviral therapy on resting energy expenditure in adult HIV-infected women-a matched, prospective, cross-sectional study.

BACKGROUND: Several studies have reported increased resting energy expenditure (REE) in people with human immunodeficiency virus (HIV). However, limited data exist on REE in HIV-infected women and the effect of antiretroviral therapy (ART) on REE in this population. OBJECTIVE: The purpose of this study was to compare REE in healthy controls to adult HIV-infected women classified in three groups: naïve to ART, on ART with virologic suppression, and on ART with an HIV-1 RNA level >5,000 copies/mL. DESIGN: After a fast, body composition by bioelectrical impedance analysis and REE by indirect calorimetry were determined. Anthropometric measures were also taken. STATISTICAL ANALYSIS: Distributionally appropriate two-sample tests were used for between-group analyses and analysis of covariance was used for confounding adjustment. RESULTS: Eighty-seven women were enrolled and the HIV-infected and control women were matched for age and body mass index. Log-transformed REE was significantly higher in HIV-infected women naïve to ART compared to controls (7.26±0.22 vs 7.14±0.19; P=0.04, respectively) and the difference remained significant after adjustment for body cell mass (P=0.008). Log-transformed REE was not different in HIV-infected women on ART compared to HIV-infected women naïve to ART (7.25±0.25 vs 7.26±0.23; P=0.81, respectively). Adjusting for body cell mass did not change the results (P=0.56). Similarly, REE was not different between women naïve to ART and those on ART with undetectable HIV-1 RNA, regardless of adjustment for body cell mass. REE correlated to current and nadir CD4 count and trended toward a negative correlation with HIV-1 RNA levels. CONCLUSIONS: We showed that REE is elevated in ART-naïve, HIV-infected women and continues to be elevated when on ART, regardless of virologic suppression, compared to age and body mass index-matched healthy women. This suggests an effect of HIV infection itself and not ART on REE in these HIV-infected women, and should be considered during nutrition assessment and counseling of HIV-infected adult women.

CD8+ T-cell activation in HIV-1-infected patients experiencing transient low-level viremia during antiretroviral therapy.

Transient low-level viremia (TLLV) of 50-400 HIV RNA copies per milliliter is common during antiretroviral therapy, but its pathogenesis, consequences, and optimal management are unclear. Heightened immune activation is associated with detrimental outcomes, including impaired CD4 T-cell reconstitution. Using CD38/HLA-DR expression on CD8 T cells measured in 2 large studies, we determined associations between TLLV and immune activation levels before, during, and after TLLV. We found that TLLV does not significantly change CD8 T-cell activation and that higher CD8 T-cell activation during viral suppression <50 copies per milliliter is associated with a modest increase in the risk of a subsequent TLLV.

How have long-term survivors coped with living with HIV?

With advances in HIV treatment, more individuals have grown older with the disease. Little is known about factors that have helped these survivors manage everyday life with HIV. In this exploratory, qualitative study, we asked, "What has helped survivors cope with challenges of living long term with HIV?" Participants were recruited from a convenience sample of persons living with HIV who obtained treatment at a specialty HIV clinic; 16 long-term survivors of HIV were interviewed. Mean age was 50.13 (SD = 8.30) years; mean time from diagnosis was 16.75 (SD = 5.98) years. Results were broadly dichotomized as coping mechanisms and social supports. Three themes characterized coping mechanisms: disease coping, practical coping, and emotional coping. Social supports included themes of family, friends, professionals, peer groups, and pets. In particular, the power of patient-professional relationships and meanings derived from religion/spirituality were considered by a majority of participants to be influential factors.

Immunologic failure despite suppressive antiretroviral therapy is related to activation and turnover of memory CD4 cells.

BACKGROUND: Failure to normalize CD4(+) T-cell numbers despite effective antiretroviral therapy is an important problem in human immunodeficiency virus (HIV) infection. METHODS: To evaluate potential determinants of immune failure in this setting, we performed a comprehensive immunophenotypic characterization of patients with immune failure despite HIV suppression, persons who experienced CD4(+) T-cell restoration with therapy, and healthy controls. RESULTS: Profound depletion of all CD4(+) T-cell maturation subsets and depletion of naive CD8(+) T cells was found in immune failure, implying failure of T-cell production/expansion. In immune failure, both CD4(+) and CD8(+) cells were activated but only memory CD4(+) cells were cycling at increased frequency. This may be the consequence of inflammation induced by in vivo exposure to microbial products, as soluble levels of the endotoxin receptor CD14(+) and interleukin 6 were elevated in immune failure. In multivariate analyses, naive T-cell depletion, phenotypic activation (CD38(+) and HLA-DR expression), cycling of memory CD4(+) T cells, and levels of soluble CD14 (sCD14) distinguished immune failure from immune success, even when adjusted for CD4(+) T-cell nadir, age at treatment initiation, and other clinical indices. CONCLUSIONS: Immune activation that appears related to exposure to microbial elements distinguishes immune failure from immune success in treated HIV infection.

Chemokine (C-C motif) receptor 5 -2459 genotype in patients receiving highly active antiretroviral therapy: race-specific influence on virologic success.

BACKGROUND: In patients receiving highly active antiretroviral therapy (HAART), antiretroviral drug-metabolizing enzyme and transporter gene polymorphisms, as well as chemokine receptor gene polymorphisms, may influence response to treatment. METHODS: In a North American, treated, adherent human immunodeficiency virus (HIV)-positive cohort (self-identified whites, n = 175; blacks, n = 218), we investigated whether CYP2B6 (516G>T, 983T>C), UGT2B7 (IVS1+985A>G, 802C>T), MDR1 3435C>T, chemokine (C-C motif) receptor 2 (CCR2) 190G>A, and CCR5 (-2459G>A, Δ32) polymorphisms influenced the time to achieve virologic success (TVLS). RESULTS: No difference in TVLS was observed between races. In Kaplan-Meier analyses, only 516G>T (log-rank P = .045 for comparison of GG, GT, and TT and P = .02 GG + GT vs TT) and -2459G>A (log-rank P = .04 for GG, GA, and AA and P = .02 for GG + GA vs AA) genotypes were significantly associated with TVLS in black patients but not in white patients. However, in the Cox proportional hazards model that included age, sex, baseline CD4(+) T cell count, and baseline viral load, no significant association was observed between 516G>T and TVLS, whereas the association between -2459G>A and TVLS remained significant even after including CCR2 190G>A as well as all the drug-metabolizing enzyme and transporter genotypes. CONCLUSIONS: These findings suggest that CCR5 -2459G>A genotype had a strong, race-specific influence on TVLS in this cohort. Understanding the possible mechanisms underlying this influence requires further studies.

Therapeutic drug monitoring of protease inhibitors and efavirenz in HIV-infected individuals with active substance-related disorders.

BACKGROUND: Achieving targeted antiretroviral (ARV) plasma concentrations during long-term treatment in human immunodeficiency virus (HIV)-infected patients with substance-related disorders (SRDs) may be challenging due to a number of factors, including medication adherence, coinfection with hepatitis B or C virus, medication intolerance, and drug interactions. One approach to investigate these factors is to conduct therapeutic drug monitoring to measure ARV exposure during treatment. The objective of this study was to utilize therapeutic drug monitoring to compare efavirenz (EFV) and protease inhibitor pharmacokinetics in patients with and without SRDs. METHODS: This was a multicenter, cross-sectional open-label study in patients with HIV-1 infection receiving antiretroviral therapy (ART), with active (n=129) or without (n=146) SRD according to National Institute on Drug Abuse criteria. Two hundred seventy-five subjects who were receiving either protease inhibitor-based or EFV-based ART regimens for >6 months were enrolled at 4 HIV treatment centers with an equal distribution of SRD and non-SRD at each site. The patients were instructed during enrollment visits with regard to the importance of adherence before and after study visits. Demographics and routine clinical laboratory tests were recorded. RESULTS: Among the 275 patients, 47% had SRD with at least 1 substance. There were no significant differences between SRD and non-SRD groups for race, gender, age, or CD4 count at entry. A significantly higher proportion of patients with SRD had an entry HIV RNA plasma concentration>75 copies per milliliter compared with patients without SRD (40% vs 28%, P=0.044). Logistic regression modeling revealed an association between HIV RNA plasma concentration and African American race (P=0.017). A significantly higher proportion of SRDs also had an EFV or protease inhibitor trough concentration below the desired range (23% vs 9%, P=0.048). Significantly lower trough concentrations were noted in patients with SRDs receiving atazanavir (0.290 vs 0.976 µg/mL) or lopinavir (3.75 vs 5.30 µg/mL). CONCLUSIONS: The pharmacokinetic data indicate differences between HIV-infected patients with and without SRDs that may influence viral load suppression during long-term ART. These findings require additional investigation in a randomized design with more intensive pharmacokinetic assessment to identify individual factors that are contributing to suboptimal ARV exposure in patients with SRDs.

Histoplasma capsulatum prosthetic valve endocarditis with negative fungal blood cultures and negative histoplasma antigen assay in an immunocompetent patient.

We report a case of Histoplasma capsulatum endocarditis in which Histoplasma antigen assay and fungal blood cultures were negative. The diagnosis was made by microscopic examination and culture of the excised valve. Histoplasma capsulatum should be considered in the differential diagnosis of culture-negative endocarditis in regions where it is endemic and in travelers.

Salsalate is poorly tolerated and fails to improve endothelial function in virologically suppressed HIV-infected adults.

In this 13-week, open-label, randomized study of the anti-inflammatory salsalate versus usual care, there were no significant improvements in flow-mediated dilation of the brachial artery, endothelial activation, inflammation or coagulation markers, homeostasis model assessment of insulin resistance or lipoproteins with salsalate or between groups in virologically suppressed, HIV-infected adults on antiretrovirals. Tinnitus and transaminitis occurred frequently in the salsalate group. Dose reduction due to toxicities encountered and low level of inflammation may explain these results.