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1.  Metabolic Syndrome Predicts All-Cause Mortality in Persons with Human Immunodeficiency Virus 
AIDS Patient Care and STDs  2013;27(5):266-271.
Abstract
We examined the association between metabolic syndrome (MS) and its individual defining criteria on all-cause mortality in human immunodeficiency virus (HIV)-infected persons. We used data from 567 HIV-infected participants of the Nutrition for Healthy Living study with study visits between 9/1/2000 and 1/31/2004 and determined mortality through 12/31/2006. MS was defined using modified National Cholesterol Education Program guidelines. Cox proportional hazards for all-cause mortality were estimated for baseline MS status and for its individual defining criteria. There were 83 deaths with median follow-up of 63 months. Baseline characteristics associated with increased risk of mortality were: older age in years (univariate hazard ratio [HR] 1.04, p<0.01), current smoking (HR 1.99, p=0.02), current heroin use (HR 1.97, p=0.02), living in poverty (HR 2.0, p<0.01), higher mean HIV viral load (HR 1.81, p<0.01), and having a BMI <18 (HR 5.84, p<0.01). For MS and its criteria, only low HDL was associated with increased risk of mortality on univariate analysis (HR 1.84, p=0.01). However, metabolic syndrome (adjusted HR 2.31, p=0.02) and high triglycerides (adjusted HR 3.97, p<0.01) were significantly associated with mortality beyond 36 months follow-up. MS, low HDL, and high triglycerides are associated with an increased risk of mortality in HIV-infected individuals.
doi:10.1089/apc.2012.0402
PMCID: PMC3651687  PMID: 23651103
2.  Development of a nutrient-dense food supplement for HIV-infected women in rural Kenya using qualitative and quantitative research methods 
Public health nutrition  2012;16(4):721-729.
Objective
Formative research to facilitate the development, packaging and delivery of a culturally acceptable nutrition intervention for HIV-infected women in rural Kenya for an intervention trial.
Design
Focus group discussion on three areas: (i) ingredients and form of the nutrition intervention, (ii) packaging and delivery and (iii) monitoring of adherence. Two single-blind taste tests with eleven different porridge formulations of various combinations of maize flour, soyabeans, peanuts, sorghum, mung beans, dried fish, raisins and dried whole milk. Follow-up acceptability focus group discussion was also conducted.
Setting
Voi, Kenya, community based.
Subjects
Focus group discussion and two taste tests (twenty-one women aged 16–55 years). Follow-up acceptability focus group discussion (four women enrolled in intervention trial).
Results
The preferred porridge for taste consisted of maize, soyabeans and peanuts. For animal protein, dried whole milk and dried fish were used. Although the women disliked the taste of dried fish, it was acceptable if added in small undetectable quantities. Sugar over lime was favoured for taste. Women believed they could consume at least two cups of porridge per day without displacing their usual meals. The optimal delivery interval was believed to be every two weeks in individual serving packages. Women who had been consuming porridge for several weeks felt the taste was acceptable for long-term consumption.
Conclusions
This formative research resulted in the development, packaging and delivery of a nutrient-dense food supplement using local ingredients to meet the dietary needs of the population and acceptable for daily consumption by women in Kenya for evaluation in an intervention trial.
doi:10.1017/S1368980012004156
PMCID: PMC3984962  PMID: 22974548
HIV; Africa; Kenya; Nutrition therapy
3.  Comparison of standard PCR/cloning to single genome sequencing for analysis of HIV-1 populations 
Journal of virological methods  2010;168(0):114-120.
To compare standard PCR/cloning and single genome sequencing (SGS) in their ability to reflect actual intra-patient polymorphism of HIV-1 populations, a total of 530 HIV-1 pro-pol sequences obtained by both sequencing techniques from a set of 17 ART naïve patient specimens was analyzed. For each specimen, 12 and 15 sequences, on average, were characterized by the two techniques. Using phylogenetic analysis, tests for panmixia and entropy, and Bland-Altman plots, no difference in population structure or genetic diversity was shown in 14 of the 17 subjects. Evidence of sampling bias by the presence of subsets of identical sequences was found by either method. Overall, the study shows that neither method was more biased than the other, and providing that an adequate number of PCR templates is analyzed, and that the bulk sequencing captures the diversity of the viral population, either method is likely to provide a similar measure of population diversity.
doi:10.1016/j.jviromet.2010.04.030
PMCID: PMC3949620  PMID: 20451557
HIV; Single genome sequencing (SGS); pro-pol diversity; cloning and sequencing; treatment naïve
4.  Drug Use and Other Risk Factors Related to Lower Body Mass Index among HIV-Infected Individuals 
Drug and alcohol dependence  2008;95(0):10.1016/j.drugalcdep.2007.12.004.
Malnutrition is associated with morbidity and mortality in HIV infected individuals. Little research has been conducted to identify the roles that clinical, illicit drug use and socioeconomic characteristics play in the nutritional status of HIV-infected patients. This cross-sectional analysis included 562 HIV-infected participants enrolled in the Nutrition for Healthy Living study conducted in Boston, MA and Providence, RI. The relationship between body mass index (BMI) and several covariates (type of drug use, demographic, and clinical characteristics) were examined using linear regression.
Overall, drug users had a lower BMI than non-drug users. The BMI of cocaine users was 1.4 kg/m2 less than that of patients who did not use any drugs, after adjusting for other covariates (p= 0.02). The BMI of participants who were over the age of 55 years was 2.0 kg/m2 less than that of patients under the age of 35, and BMI increased by 0.3 kg/m2 with each 100 cells/mm3 increase in CD4 count. HAART use, adherence to HAART, energy intake, AIDS status, hepatitis B and hepatitis C co-infections, cigarette smoking and depression were not associated with BMI in the final model.
In conclusion, BMI was lower in drug users than non-drug users, and was lowest in cocaine users. BMI was also directly associated with CD4 count and inversely related to age more than 55 years old. HIV infected cocaine users may be at higher risk of developing malnutrition, suggesting the need for anticipatory nutritional support.
doi:10.1016/j.drugalcdep.2007.12.004
PMCID: PMC3837518  PMID: 18243579
drug users; cocaine users; BMI; HIV; CD4 count
5.  HIV-1 Sero-Prevalence and Awareness of Mother-to-Child Transmission Issues Among Women Seeking Antenatal Care in Tamil Nadu, India 
Background
Despite increasing availability of HIV-1 testing, education, and methods to prevent transmission, Indian women and their children remain at risk of acquiring HIV. We assessed the sero-prevalence and awareness about HIV among pregnant women presenting to a private tertiary care hospital in South India.
Methods
Sero-prevalence was determined via enzyme-linked immunosorbent assay (ELISA) testing, and questionnaires were analyzed using chi-square statistics and odds ratios to look for factors associated with HIV positivity.
Results
A total of 7956 women who presented for antenatal care were interviewed. Fifty-one women of the 7235 women who underwent HIV testing (0.7%) were found to be HIV positive. Awareness of mother-to-child transmission (MTCT) of HIV (64%), HIV transmission through breast milk (42%), and prevention of MTCT (13%) was low.
Conclusions
There is a need to educate South Indian women about HIV to give them information and the means to protect themselves and their unborn children from acquiring HIV.
doi:10.1177/1545109710371132
PMCID: PMC3652013  PMID: 20530464
HIV; sero-prevalence; awareness; pregnancy; antenatal; India
6.  Knowledge of HIV Transmission and Associated Factors among HIV-Positive and HIV-Negative Patients in Rural Kenya 
Summary
Knowledge of HIV transmission is a prerequisite to practicing safer behaviors to prevent HIV infections and may be expected to vary by region because of cultural and socioeconomic determinants. A cross-sectional study was conducted in rural Kenya using a standardized questionnaire assessing HIV transmission knowledge, socio-demographic and other characteristics. Participants were recruited from the voluntary counseling and testing clinic and the general hospital population of Moi District Hospital. “High” HIV transmission knowledge scorers (≥ 81%) (Mean score) were compared with “low” scorers (<81%). Bivariate and multivariate logistic regression analyses were performed to examine factors associated with HIV transmission knowledge. Of 214 participants, 70 (33%) were HIV-positive, 104 (49%) were HIV-negative, and 40 (19%) did not know. Factors associated with low knowledge in multivariate analyses were lower education (OR 2.36, CI 1.03–5.46), lower household money on healthcare (OR 2.03, CI 1.28–3.21), higher clinic transportation costs (OR 3.14, CI 1.20–9.82), sex without a condom (OR 2.18, CI 1.12–4.26), positive HIV status vs. negative (OR 2.50, CI 1.22–5.26) and positive HIV status vs. unknown (OR 3.57, CI 1.33–9.09). Mean HIV transmission knowledge score was relatively high; however, a large proportion of patients demonstrated low knowledge. Identifying individuals at risk for low knowledge will support targeted HIV education and prevention programs.
doi:10.4172/2155-6113.1000170
PMCID: PMC3595060  PMID: 23495369
7.  Medication Possession Ratio Associated with Short-Term Virologic Response in Individuals Initiating Antiretroviral Therapy in Namibia 
PLoS ONE  2013;8(2):e56307.
The visual-analogue scale (VAS), Likert item (rating scale), pills identification test (PIT), and medication possession ratio (MPR) provide estimates of antiretroviral therapy (ART) adherence which correlate with HIV viral suppression. These simple adherence measures are inexpensive and easy to administer; however, require validation and adjustment prior to implementation. The objective of this study was to define the optimal adherence assessment measure in Namibia to identify patients at risk for sub-optimal adherence and poor virologic response 6 months after ART initiation. We conducted a cross-sectional survey in HIV-infected adults receiving ART for 6–12 months prior to the adherence assessment. Adherence measures included 30-day VAS, 30-day Likert item, self-reported treatment interruptions, PIT, and MPR. Association of adherence measures with 6-month HIV-1 RNA level was assessed using two thresholds (1000 copies/mL and 5000 copies/mL). Adherence was assessed in 236 patients, mean age 37.3 years, 54% female. Mean adherence was 98.1% by 30-day VAS, 84.7% by 30-day Likert item, 97.0% by self-reported treatment interruptions, 90.6% by PIT, and 98.8% by MPR. Agreement between adherence measures was poor using kappa statistic. 76% had HIV-1 RNA <1000 copies/ml, and 88% had HIV-1 RNA <5000 copies/ml. MPR (continuous) was associated with viral suppression <5000 copies/ml (p = 0.036). MPR <75% was associated with virologic failure at ≥5000 copies/ml with OR 3.89 (1.24, 12.21), p = 0.013. Adherence was high with all measures. Only MPR, was associated with short-term virologic response, suggesting its cross-culturally utility for early identification of patients at high risk for virologic failure.
doi:10.1371/journal.pone.0056307
PMCID: PMC3585291  PMID: 23509605
8.  Antimicrobial Prescribing in the U.S. for Adult Acute Pharyngitis in Relation to Treatment Guidelines 
i. Rationale, aims and objectives
American College of Physicians (ACP) published guidelines for the diagnosis and treatment of acute pharyngitis in adults in 2001. The objective of this study is to characterize antibiotic prescribing patterns in the United States for acute pharyngitis and evaluate concordance with the 2001 ACP pharyngitis treatment guidelines
ii. Methods
Patients aged ≥18 years identified with acute pharyngitis via (ICD-9 CM) diagnosis codes were identified from data collected annually (1996-2006) by the National Center for Health Statistics (NCHS) and Centers for Disease Control and Prevention (CDC) from the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS). Total US office visits for acute pharyngitis were estimated. Logistic regression was performed to determine whether antibiotic prescribing was associated with the publishing of the ACP guidelines.
iii. Results
3,791 office visits met study criteria. We extrapolated 78.0 million visits for acute pharyngitis from 1996-2006. Antibiotics were prescribed in 62.6% of cases and 7.5% of cases received ACP-recommended antibiotics. There was a significant decrease in the rate of antibiotic prescriptions from 66.5% to 59.1% after publication of ACP guidelines. Univariate analysis showed that antibiotic prescribing decreased by 27%, OR=0.73 (0.55-0.95), p=0.021. Multivariate analyses confirmed this finding, OR=0.72 (0.56-0.94), p=0.014. The prescribing of ACP-recommended antibiotics did not significantly change, 8.5% to 6.6% p=0.519.
iv. Conclusions
Publishing of ACP guidelines for the diagnosis and treatment of pharyngitis was associated with a decrease in the overall prescribing of antibiotics but not the prescribing of ACP-recommended antibiotics.
doi:10.1111/j.1365-2753.2010.01495.x
PMCID: PMC2978269  PMID: 20586844
guidelines; infectious disease; pharmacoepidemiology; physician behavior; health education
9.  Malnutrition in a population of HIV-positive and HIV-negative drug users living in Chennai, South India 
Drug and alcohol dependence  2011;118(1):73-77.
Background
Malnutrition is a strong predictor of poor outcomes in people living with HIV (PLHIV). Drug users are at increased risk of malnutrition regardless of whether or not they are infected with HIV. Little data exists on the nutritional status of drug users (with or without HIV infection) in India.
Methods
We describe and compare the nutrition and metabolic status of 107 HIV-positive and 193 HIV-negative male clients of a community-based drop-in center for injection drug users in Chennai, India. Measures of nutrition and metabolic status include body composition, dietary intake, food insecurity, and serum lipid levels.
Results
We found poor overall nutritional status in both the HIV-positive and HIV-negative clients, with HIV-positive men faring worse on some parameters. Both groups had extremely low percent body fat, but levels in HIV-positive participants were significantly lower (6.5% vs. 7.9%, p=.01). HIV-positive men also had significantly lower total caloric and fat intakes compared to HIV-negative men. A considerable proportion (70%) of both HIV-positive and HIV-negative drug users were food insecure. HDL cholesterol levels were significantly lower and below normal range in the HIV-positive compared to HIV-negative men.
Conclusions
The high levels of food insecurity and poor nutritional status in this population, regardless of HIV status, indicates critical need for intervention. Improving nutritional status in those who are infected with HIV prior to initiation of antiretroviral treatment may help patients to reap the full benefits of therapy.
doi:10.1016/j.drugalcdep.2011.02.020
PMCID: PMC3130882  PMID: 21420798
Nutritional status; injection drug users; India; HIV-infection
10.  Repeated assessments of food security predict CD4 change in the setting of antiretroviral therapy 
Food insecurity is highly prevalent in HIV-infected populations, and analyses utilizing multiple assessments of food security to predict CD4 change are lacking. 592 patients with ≥ 4 food security assessments were followed prospectively. In the final model, for patients using antiretroviral therapy, increases in CD4 counts were on average 99.5 cells less for individuals with at least one episode of food insecurity compared to those consistently food secure (P < 0.001). Other sociodemographic factors were not predictive. Repeated assessments of food security are potent predictors of treatment response notwithstanding antiretroviral therapy use. Potential mechanisms for this association are proposed.
doi:10.1097/QAI.0b013e318227f8dd
PMCID: PMC3159819  PMID: 21694604
Food security; Immunological response; Antiretroviral therapy
11.  A Randomized Trial of Raltegravir Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor in HIV-Infected Women with Lipohypertrophy 
AIDS Patient Care and STDs  2012;26(9):532-540.
Abstract
Lipohypertrophy in HIV-infected patients is associated with metabolic abnormalities. Raltegravir (RAL) is not known to induce fat changes or severe metabolic perturbations. HIV-infected women with central adiposity and HIV-1 RNA less than 50 copies per milliliter on non-nucleoside reverse transcriptase inhibitor (NNRTI)- or protease inhibitor (PI)-based antiretroviral therapy (ART) continued their nucleoside reverse transcriptase inhibitor (NRTI) backbone and were randomized to switch to open label RAL immediately or after 24 weeks. The primary end point was 24-week between-group change in computed tomography (CT)-quantified visceral adipose tissue (AT) volume. Fasting lipids, glucose, C-reactive protein (CRP), anthropometric measurements, and patient-reported quality of life assessments were also measured. Thirty-six subjects provided 80% power to detect a 10% between-group difference in visceral AT over 24 weeks. Thirty-seven of 39 enrolled subjects completed week 24. At entry, subjects were 75% black or Hispanic, and on 62% PI-based and 38% NNRTI-based regimens. The median age was 43 years, CD4 count 558 cells per microliter, and body mass index (BMI) 32 kg/m2. After 24 weeks, no statistically significant changes in visceral or subcutaneous AT, anthropometrics, BMI, glucose, or CRP were observed. In subjects receiving RAL, significant improvements in total and LDL cholesterol (p=0.04), self-reported belly size (p=0.02) and composite body size (p=0.02) were observed. Body size changes correlated well with percent visceral AT change. No RAL-related adverse events occurred. Compared to continued PI or NNRTI, switch to RAL was associated with statistically significant 24-week improvements in total and LDL cholesterol but not AT volumes. Additional insights into AT and metabolic changes in women on RAL will be provided by 48-week follow-up of the immediate-switch arm.
doi:10.1089/apc.2012.0135
PMCID: PMC3426192  PMID: 22823027
12.  Pharmacy Adherence Measures to Assess Adherence to Antiretroviral Therapy: Review of the Literature and Implications for Treatment Monitoring 
Prescription or pill-based methods for estimating adherence to antiretroviral therapy (ART), pharmacy adherence measures (PAMs), are objective estimates calculated from routinely collected pharmacy data. We conducted a literature review to evaluate PAMs, including their association with virological and other clinical outcomes, their efficacy compared with other adherence measures, and factors to consider when selecting a PAM to monitor adherence. PAMs were classified into 3 categories: medication possession ratio (MPR), pill count (PC), and pill pick-up (PPU). Data exist to recommend PAMs over self-reported adherence. PAMs consistently predicted patient outcomes, but additional studies are needed to determine the most predictive PAM parameters. Current evidence suggests that shorter duration of adherence assessment (≤6 months) and use of PAMs to predict future outcomes may be less accurate. PAMs which incorporate the number of days for which ART was prescribed without the counting of remnant pills, are reasonable minimum-resource methods to assess adherence to ART.
doi:10.1093/cid/ciq167
PMCID: PMC3060901  PMID: 21245156
13.  Markers of Atherosclerosis and Inflammation and Mortality in Patients with HIV Infection 
Atherosclerosis  2010;214(2):468-473.
Objective
HIV-infected patients are at increased risk for cardiovascular disease, which may be mediated in part by inflammation. Surrogate marker studies suggest an increased prevalence of vascular abnormalities in HIV infection. We examined the association of all-cause mortality in HIV-infected patients with carotid artery intima-media thickness (cIMT) and high-sensitivity C-reactive protein (hsCRP).
Design and Methods
Baseline risk factors, cIMT and hsCRP were prospectively measured in 327 HIV-infected participants. Follow-up time with median of 3.1 years was calculated from baseline to death or censored dated 7/31/07. Cox Proportional Hazards models were used to study risk factors associated with mortality.
Results
Thirty eight (11.6 %) of participants have died since study enrollment. CIMT was significantly higher in those who died and decedents were significantly more likely to have cIMT above the 75th percentile. Those who died had higher hsCRP than those alive and more had hsCRP values above 3 mg/L. CD4 count was lower and log10 viral load was higher in decedents, but antiretroviral regimens were similar in both groups. CIMT and hsCRP levels were significantly associated with mortality (HR=2.74, 95% CI 1.26 to 5.97, p=0.01; HR=2.38, 95% CI 1.15 to 4.9, p=0.02).
Conclusions
Our study demonstrated a strong association of carotid IMT and hsCRP with all-cause death in this HIV-infected population despite being similar with respect to exposure to antiretroviral medications. Together these surrogate markers may be indices of chronic inflammation and unfavorable outcomes in HIV-positive patients.
doi:10.1016/j.atherosclerosis.2010.11.013
PMCID: PMC3034311  PMID: 21130995
14.  Poverty, Hunger, Education, and Residential Status Impact Survival in HIV 
AIDS and behavior  2011;15(7):1503-1511.
Despite combination antiretroviral therapy (ART), HIV infected people have higher mortality than non-infected. Lower socioeconomic status (SES) predicts higher mortality in many chronic illnesses but data in people with HIV is limited. We evaluated 878 HIV infected individuals followed from 1995 to 2005. Cox proportional hazards for all-cause mortality were estimated for SES measures and other factors. Mixed effects analyses examined how SES impacts factors predicting death. The 200 who died were older, had lower CD4 counts, and higher viral loads (VL). Age, transmission category, education, albumin, CD4 counts, VL, hunger, and poverty predicted death in univariate analyses; age, CD4 counts, albumin, VL, and poverty in the multivariable model. Mixed models showed associations between (1) CD4 counts with education and hunger; (2) albumin with education, homelessness, and poverty; and (3) VL with education and hunger. SES contributes to mortality in HIV infected persons directly and indirectly, and should be a target of health policy in this population.
doi:10.1007/s10461-010-9759-z
PMCID: PMC3010417  PMID: 20632079
HIV; Socioeconomic status; Mortality
15.  Association of Antiretroviral Therapy with Fibrinogen Levels in HIV Infection 
AIDS (London, England)  2008;22(6):707-715.
doi:10.1097/QAD.0b013e3282f560d9
PMCID: PMC3156620  PMID: 18356600
fibrinogen; HIV; protease inhibitors; non-nucleoside reverse transcriptase inhibitors
16.  Circulating Nef Induces Dyslipidemia in SIV-Infected Macaques by Suppressing Cholesterol Efflux 
The Journal of infectious diseases  2010;202(4):614-623.
HIV infection and subsequent antiretroviral therapy have been associated with an increased incidence of dyslipidemia and cardiovascular disease and has been shown to suppress cholesterol efflux from virus-infected macrophages by inducing Nef-dependent downregulation of ABCA1. The SIV/macaque model was used to examine consequences and mechanisms involved. SIV infection drove a significant remodeling of high-density lipoprotein profiles suggesting systemic inhibition of the ABCA1-dependent reverse cholesterol transport pathway. The ABCA1 cholesterol transporter was significantly down regulated in the livers of the SIV-infected macaques and the viral protein Nef could be detected in the liver as well as in plasma of infected animals. Extracellular myristoylated HIV Nef inhibited cholesterol efflux from macrophages and hepatocytes. Moreover, sera from SIV-infected macaques also suppressed cholesterol efflux in a Nef-dependent fashion. These results indicate that SIV infection is a significant contributor to primary dyslipidemia, likely through the ability of Nef to suppress ABCA1-dependent reverse cholesterol transport.
doi:10.1086/654817
PMCID: PMC2932757  PMID: 20617930
HIV; SIV; ABCA1; Nef; atherosclerosis
17.  Predictors of Weight Change in Male HIV-Positive Injection Drug Users Initiating Antiretroviral Therapy in Hanoi, Vietnam 
AIDS Research and Treatment  2011;2011:890308.
We examined clinical and nutritional predictors of weight change over two consecutive 6-month intervals among 99 HIV-positive male injection drug users initiating antiretroviral therapy (ART) in Hanoi, Vietnam. The average weight gain was 3.1 ± 4.8 kg in the first six months after ART and 0.8 ± 3.0 kg in the following six months. Predictors of weight change differed by interval. In the first interval, CD4 < 200 cells/μL, excellent/very good adherence to ART, bothersome nausea, and liquid supplement use were all associated with positive weight changes. Moderate to heavy alcohol use and tobacco smoking were associated with negative weight changes. In the second interval, having a CD4 count <200 cells/μL at the beginning of the interval and tobacco smoking were the only significant predictors and both were associated with negative weight changes. We identified several potential areas for interventions to promote weight gain immediately after starting ART in this population. Studies are needed to determine whether improving weight prior to, or at, ART initiation will result in improved outcomes on ART.
doi:10.1155/2011/890308
PMCID: PMC3137978  PMID: 21776380
18.  Dyslipidemia among HIV-infected Patients with Tuberculosis Taking Once-daily Nonnucleoside Reverse-Transcriptase Inhibitor–Based Antiretroviral Therapy in India 
HIV-infected patients with tuberculosis who initiate nonnucleoside reverse-transcriptase-based anti-retroviral treatment in combination with rifampicin-based antituberculosis treatment demonstrate increases in total cholesterol, low-density cholesterol, and high-density cholesterol levels but no change in blood glucose level after 1 year. Cholesterol increases were more frequent among patients receiving efavirenz.
Background. Our aim was to study the incidence and pattern of dyslipidemia among human immunodeficiency virus (HIV)–infected patients with tuberculosis (TB) who received once-daily antiretroviral therapy (ART).
Methods. Antiretroviral-naive HIV-infected patients with TB were recruited to a trial of once-daily nonnucleoside reverse-transcriptase inhibitor (NNRTI)–based ART and treated with rifampicin-based thrice-weekly antituberculosis treatment (ATT); participants were randomized to receive didanosine (250/400 mg) and lamivudine (300 mg) with either efavirenz (600 mg) or nevirapine (400 mg) once-daily after an intensive phase of ATT. Fasting triglyceride (TG) level, total cholesterol (TC) level, low-density cholesterol (LDL-c) level and high-density cholesterol (HDL-c) level were measured at baseline and at 6 and 12 months. Lipid levels at 6 and 12 months were compared with baseline values with use of repeated measures analyses. McNemar test was used to compare the proportion of patients with lipid abnormality at baseline versus at 12 months, and χ2 test was used to compare between the 2 groups.
Results. Of 168 patients (79% men; mean age, 36 years; mean weight, 42 kg; median CD4+ cell count, 93 cells/mm3), 104 received efavirenz-based ART, and 64 received nevirapine-based ART. After 6 months, TC levels increased by 49 mg/dL, LDL-c levels by 30 mg/dL, and HDL-c levels increased by 18 mg/dL (P < .001 for all). At baseline and at 12 months, TC was >200 mg/dL for 1% and 26% of patients, respectively; LDL-c level was >130 mg/dL for 3% and 23%, respectively; HDL-c level was <40 mg/dL for 91% and 23%, respectively; and blood glucose level was >110 mg/dL for 14% and 13%, respectively. TC level >200 mg/dL was more common among patients who received efavirenz than among those who received nevirapine (32% vs 16%; P = .04).
Conclusions. HIV-infected patients with TB who initiate NNRTI-based ART undergo complex changes in lipid profile, highlighting the importance of screening and treating other cardiovascular disease risk factors in this population.
doi:10.1093/cid/ciq195
PMCID: PMC3060904  PMID: 21252141
19.  Correlates of HIV-1 viral suppression in a cohort of HIV-positive drug users receiving antiretroviral therapy in Hanoi, Vietnam 
Summary
Injection drug users bear the burden of HIV in Vietnam and are a focus of national treatment programs. To date, determinants of successful therapy in this population are unknown. Substance use and clinical correlates of viral suppression were studied in 100 HIV-1 infected drug users receiving antiretroviral therapy (ART) for at least 6 months in Hanoi, Vietnam. Mean age of the cohort was 29.9 + 4.9 years; all were men. A majority of patients (73%) achieved viral suppression (HIV-RNA < 1000 copies/ml). Correlates of viral suppression include self-reported >95% adherence (p<0.01) and current use of trimethoprim/sulfamethoxazole (p<0.01); current or ever diagnosed with tuberculosis was associated with viral non-suppression (p=0.006). Tobacco use was prevalent (84%), and surprisingly 48% of patients reported active drug use; neither was associated with viral non-suppression. This is the first study to document successful ART treatment in a population of Vietnamese drug users; rates of viral suppression are comparable to other international populations. The 28% of patients without HIV-1 suppression highlights the need for adherence promotion, risk reduction programs, and population based surveillance strategies for assessing the emergence of HIV drug resistance in settings where access to viral load and drug resistance testing is limited.
doi:10.1258/ijsa.2008.008389
PMCID: PMC2887676  PMID: 19451329
HIV; Vietnam; antiretroviral therapy; substance abuse; adherence
20.  Knowledge, Beliefs, and Health Care Practices Relating to Treatment of HIV in Vellore, India 
AIDS Patient Care and STDs  2009;23(6):477-484.
Abstract
In India, little is known about health care-seeking behavior among HIV-infected individuals. Similarly, little is known about how HIV is being treated in the community, in particular by Indian Systems of Medicine (ISM) providers. Therefore, while ART implementation programs continue to expand, it is important to determine whether the knowledge, attitudes, and treatment practices of HIV-infected individuals and their health care providers are aligned with current treatment recommendations. We conducted in-depth qualitative interviews with persons with HIV (n = 9 men and 17 women), family members of persons with HIV (n = 14 men and 3 women), and ISM providers (n = 7). Many of the patients we studied turned at some point to ISM providers because they believed that such practitioners offer a cure for HIV. ISM treatments sometimes had negative impacts including side effects, unchecked progression of an underlying illness, and financial depletion. Indian women tended to be less knowledgeable about HIV and HIV treatments, and had less access to financial and other resources, than men. Finally, most of the ISM providers reported dangerous misconceptions about HIV transmission, diagnosis, and treatment. While the existence of ART in India is potentially of great benefit to those with HIV infection, this study shows that a variety of social, cultural and governmental barriers may interfere with the effective use of these therapies. Partnerships between the allopathic and traditional/complementary health sectors in research, policy, and practice are essential in building comprehensive HIV/AIDS treatment strategies.
doi:10.1089/apc.2008.0222
PMCID: PMC2856563  PMID: 19519232
21.  Heavy injection drug use is associated with lower percent body fat in a multi-ethnic cohort of HIV-positive and HIV-negative drug users from three U.S. cities 
Background
The clinical implications of lower body weight in drug using populations are uncertain given that lower mean weights may still fall within the healthy range.
Objectives
To determine the effect of type, mode and frequency of drug use on underlying body composition after accounting for differences in body shape and size.
Methods
We conducted a cross-sectional analysis of 511 participants from the Tufts Nutrition Collaborative (TNC) Study. Data included measures of body composition, a 24-hour dietary recall, and a detailed health history and lifestyle questionnaire. Multivariate regression analysis was used to determine the independent effect of drug use on percent body fat (BF) after adjusting for BMI and waist circumference.
Results
Heavy injection drug users (IDUs) had a 2.6% lower percent BF than non-users after adjusting for BMI, waist circumference, and other confounders. (p=0.0006). Differences in percent BF were predominantly due to higher lean mass, rather than lower fat mass. Cocaine and heroin had similar effects on body composition.
Conclusions
In the U.S., where the general population is prone to over-nutrition, the average percent BF for heavy injectors does not fall into a range low enough to suggest harmful effects. However, in populations with substantial levels of under-nutrition, small differences in percent BF among drug users will have a greater impact on health status.
Scientific Significance
Differences in BMI, weight and body composition are not always straightforward. Accounting for underlying nutritional status and relative differences in fat and FFM is critical when interpreting results.
doi:10.3109/00952990903544851
PMCID: PMC2837874  PMID: 20141402
22.  Predictors of insulin resistance among Hispanic adults infected with or at risk of infection with the human immunodeficiency virus and hepatitis C virus 
Journal of viral hepatitis  2008;15(12):878-887.
Summary
Both the human immunodeficiency (HIV) and hepatitis C (HCV) viruses have been associated with insulin resistance (IR). However, our understanding of the prevalence of IR, the underlying mechanisms and predisposing factors is limited, particularly among minority populations. We conducted a study of 333 Hispanic adults including: 76 HIV-monoinfected, 62 HCV mono-infected, 97 HIV/HCV co-infected, and 98 uninfected controls with a specific focus on HCV infection and liver injury as possible predictors of IR. IR was measured using the QUICKI index. The majority (55% to 69%) of participants in all groups had QUICKI values <0.350. Body mass index was associated with IR in all groups. Triglycerides were associated with IR in the uninfected control group only (−1.83, SE = 0.58, p=0.0022). HCV was associated with IR in participants infected with HIV (−0.012, SE = 0.0046, p=0.010). Liver injury, as measured by FIB-4 score, was significantly associated with IR independently of HCV infection (−0.0035, SE=0.0016, p=0.027). In the HIV/HCV co-infected group, treatment with nucleoside reverse-transcriptase inhibitors plus non-nucleoside reverse-transcriptase inhibitors (−0.021, SE=0.080, p=0.048), but not protease inhibitors (−0.000042, SE=0.0082, p=0.96) was associated with IR. HCV infection and antiretroviral agents, including NRTI plus NNRTI treatment are contributors to IR in HIV infection. Liver injury, as measured by the FIB-4 score, is a predictor of IR independently of HCV infection.
doi:10.1111/j.1365-2893.2008.01021.x
PMCID: PMC2784594  PMID: 19087226
QUICKI; insulin resistance; HIV; HCV; Hispanic; antiretroviral therapy; liver disease
23.  Metabolic Syndrome and Subclinical Atherosclerosis in Patients Infected with HIV 
Background
The present study examines the association between carotid and coronary atherosclerosis and metabolic syndrome in human immunodeficiency virus (HIV)–infected adults.
Methods
We measured the common and internal carotid intima-media thickness (c-IMT) using B-mode ultrasonography, and we measured coronary artery calcium (CAC) using high-resolution, electrocardiographic, synchronized, computed tomography, for 314 HIV-infected men and women. Metabolic syndrome was defined by National Cholesterol Education Program/Adult Treatment Panel III criteria. We compared the c-IMT measurements and CAC scores of patients with metabolic syndrome with the scores of those without metabolic syndrome using a Wilcoxon test for continuous variables and a χ2 test for categorical variables. To examine the association between surrogate markers and metabolic syndrome, we used logistic regression analysis.
Results
Participants with metabolic syndrome were more likely to have a common c-IMT measurement >0.8 mm than were those without metabolic syndrome (17% vs.7%; P=.009), but both groups were equally likely to have an internal c-IMT measurement >1.0 mm (20% vs. 13%; P=.15). Any positive CAC score was more likely to occur for participants with metabolic syndrome (80.3% vs. 46.7%; P < .0001). In a multivariate model adjusted for sex, age, ethnicity, and smoking status, participants with metabolic syndrome were more likely than those without metabolic syndrome to have an abnormal common c-IMT measurement (odds ratio [OR], 2.9; P= .020) and detectable CAC scores (OR, 4.9; P < .0001) but not a higher internal c-IMT measurement (OR, 1.6; P=.255).
Conclusion
Our study demonstrates that HIV-infected individuals with metabolic syndrome may be at increased risk for subclinical atherosclerosis and supports screening for metabolic syndrome among HIV-infected patients at risk for cardiovascular disease.
doi:10.1086/516616
PMCID: PMC2745593  PMID: 17443477
24.  Dietary patterns and health and nutrition outcomes in men living with HIV infection123 
Background
Nutritional status is an important determinant of HIV outcomes.
Objective
We assessed the association between dietary patterns identified by cluster analysis and change in body mass index (BMI; in kg/m2), CD4 count, and viral load (VL).
Design
HIV-positive adult male subjects (n = 348) with a BMI ≥ 20.5 were evaluated by biochemical, body composition, and dietary data. Cluster analysis was performed on 41 designated food groups derived from 3-d food records. Dietary clusters were compared for sociodemographic, nutrient intake, and clinical outcomes. Multivariate linear regression assessed associations between dietary clusters and change in BMI, CD4 count, and VL.
Results
We observed 3 dietary patterns: juice and soda; fast food and fruit drinks; and fruit, vegetable, and low-fat dairy. Subjects in the fast food and fruit drinks pattern had the lowest fiber intake, highest VL, and lowest CD4 count and had a lower income than did subjects in the other 2 clusters. Subjects in the fruit, vegetable, and low-fat dairy diet pattern had higher intakes of protein, fiber, and micronutrients and the highest BMI and CD4 count. Subjects in the juice and soda pattern had higher energy intakes and lowest BMI. On average, the fast food and fruit drinks cluster and fruit, vegetable, and low-fat dairy cluster gained 0.33 (P = 0.06) and 0.42 (P = 0.02), respectively, more in BMI than the juice and soda cluster across the study interval in a multivariate model.
Conclusions
In a cohort of HIV-positive men, we identified 3 distinct dietary patterns; each pattern was associated with specific nutrition, demographic, and HIV-related variables.
doi:10.3945/ajcn.2008.26098.
PMCID: PMC2735882  PMID: 19064519
25.  Association of HIV Infection and HIV/HCV Coinfection With C-Reactive Protein Levels 
Objective
Inflammation is a potential mechanism to explain the accelerated atherosclerosis observed in HIV- and hepatitis C virus (HCV)–infected persons. We evaluated C-reactive protein (CRP) in HIV-infected and HIV/HCV-coinfected individuals in the era of effective antiretroviral (ARV) therapy.
Design
Cross-sectional study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM) cohort and controls from the Coronary Artery Risk Development in Young Adults (CARDIA) study.
Methods
CRP levels were measured in 1135 HIV-infected participants from the FRAM cohort and 281 controls from the CARDIA study. The associations of HIV and HIV/HCV infection with CRP levels were estimated by multivariable linear regression.
Results
Compared with controls, HIV monoinfection was associated with an 88% higher CRP level in men (P < 0.0001) but with no difference in women (5%; P = 0.80) in multivariate analysis. CRP levels were not associated with ARV therapy, HIV RNA level, or CD4 cell count. Compared with controls, HIV/HCV coinfection was associated with a 41% lower CRP level in women (P = 0.012) but with no difference in men (+4%; P = 0.90). Among HIV-infected participants, HCV coinfection was associated with 50% lower CRP levels after multivariable analysis (P < 0.0001) in men and women. Greater visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) were strongly associated with CRP levels. Among HIV- infected participants, CRP levels were 17% (P < 0.001) and 21% (P = 0.002) higher per doubling of VAT and SAT; among controls, CRP levels were 34% (P < 0.001) and 61% (P = 0.009) higher, respectively.
Conclusions
In the absence of HCV coinfection, HIV infection is associated with higher CRP levels in men. HCV coinfection is associated with lower CRP levels in men and women.
doi:10.1097/QAI.0b013e3181685727
PMCID: PMC2561207  PMID: 18344877
cardiovascular disease; C-reactive protein; hepatitis C virus; HIV; inflammation

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