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1.  Association of HIV infection with Incident Diabetes Mellitus: Impact of using Hemoglobin A1C as a Criterion for Diabetes 
Background
Data regarding the association between HIV and DM are conflicting, with little known regarding the impact of including hemoglobin A1C (A1C) as a criterion for DM.
Methods
Pooled logistic regression was used to quantify the association between HIV and DM in 1501 HIV-infected and 550 HIV-uninfected participants from the Women’s Interagency HIV Study. Incident DM was defined using three DM definitions: (I) fasting glucose (FG) ≥126mg/dl, anti-DM medication, or reporting DM diagnosis (with confirmation by FG≥126mg/dl or anti-DM medication); (II) confirmation with a second FG≥126mg/dl; and (III) addition of A1C≥6.5% confirmed by FG≥126mg/dl or anti-DM medication.
Results
DM incidence per 100 person-years was 2.44, 1.55, and 1.70 for HIV-infected women; 1.89, 0.85, and 1.13 for HIV-uninfected women, using definition I, II, and III, respectively. After adjustment for traditional DM risk factors, HIV infection was associated with 1.23, 1.90, and 1.38-fold higher risk of incident DM, respectively; the association reached statistical significance only when confirmation with a second FG≥126mg/dl was required. Older age, obesity, and a family history of DM were each consistently and strongly associated with increased DM risk.
Conclusions
HIV infection is consistently associated with greater risk of DM. Inclusion of an elevated A1C to define DM increases the accuracy of the diagnosis and only slightly attenuates the magnitude of the association otherwise observed between HIV and DM. By contrast, a DM diagnosis made without any confirmatory criteria for FG ≥126mg/dl overestimates the incidence, while also underestimating the effects of HIV on DM risk, and should be avoided.
doi:10.1097/QAI.0b013e31826bfc32
PMCID: PMC3480977  PMID: 22878421
Diabetes mellitus; HIV; Women; Hemoglobin A1C
2.  Improved Estimation of the Distribution of Suppressed Plasma HIV-1 RNA in Men Receiving Effective Antiretroviral Therapy 
Plasma HIV-1 RNA was measured in 306 samples, collected from 273 highly active antiretroviral therapy (HAART)-experienced men, using both the Roche COBAS TaqMan (limit of detection [LD]=20 copies/mL) and Roche Amplicor (LD=50 copies/mL) assays. Mixtures of Gaussian distributions incorporating left-censored data were used in analyses. The more sensitive TaqMan assay estimated that 23% and 0.0003% of HIV-1 RNA values would be below 1 copy/mL and 1 copy/3L, respectively. This is in sharp contrast to the overestimation provided by the less sensitive Amplicor assay, whereby the corresponding predicted percentages were 51% and 1%. Both assays appropriately characterized sub-optimal virologic response as the rightmost peaks of both distributions provided an excellent fit to the observed data. Our results based on a widely available 20 copies/mL sensitive assay reproduce those obtained using customized assays that quantified HIV-1 RNA values as low as 1 copy/mL.
doi:10.1097/QAI.0b013e318246bfce
PMCID: PMC3299865  PMID: 22217679
limit of detection; HIV-1 RNA; bimodal distribution; HAART
3.  Improved equations estimating GFR in children with chronic kidney disease using an immunonephelometric determination of cystatin C 
Kidney international  2012;82(4):445-453.
The Chronic Kidney Disease in Children study is a cohort of about 600 children with chronic kidney disease (CKD) in the United States and Canada. The independent variable for our observations was a measurement of glomerular filtration rate (GFR) by iohexol disappearance (iGFR) at the first two visits one year apart and during alternate years thereafter. In a previous report, we had developed GFR estimating equations utilizing serum creatinine, blood urea nitrogen, height, gender and cystatin C measured by an immunoturbidimetric method; however the correlation coefficient of cystatin C and GFR (-0.69) was less robust than expected. Therefore, 495 samples were re-assayed using immunonephelometry. The reciprocal of immunonephelometric cystatin C was as well correlated with iGFR as was height/serum creatinine (both 0.88). We developed a new GFR estimating equation using a random 2/3 of 965 person-visits and applied it to the remaining 1/3 as a validation data set. In the validation data set, the correlation of the estimated GFR with iGFR was 0.92 with high precision and no bias; 91% and 45% of eGFR values were within 30% and 10% of iGFR, respectively. This equation works well in children with CKD in a range of GFR from 15 to 75 ml/min per 1.73 m2. Further studies are needed to establish the applicability to children of normal stature and muscle mass, and higher GFR.
doi:10.1038/ki.2012.169
PMCID: PMC3433576  PMID: 22622496
4.  Predictive power of hepatitis B 1762T/1764A mutations in plasma for hepatocellular carcinoma risk in Qidong, China 
Carcinogenesis  2011;32(6):860-865.
Hepatocellular carcinoma (HCC) is a leading cause of cancer mortality with nearly 700 000 deaths occurring annually. Hepatitis B virus (HBV) is a major contributor to HCC and acquired mutations in the HBV genome may accelerate its pathogenesis. In this study, a matched case–control investigation of 345 men who died of HCC and 625 controls were nested within a cohort of male hepatitis B surface antigen (HBsAg) carriers from Qidong, China. Matched preserving odds ratios (ORs) were used as a measure of association and 95% confidence intervals (CIs) as a measure of precision. Real-time polymerase chain reaction allowed for a quantitative comparison of the levels of the HBV 1762T/1764A mutation in cases and controls. A total of 278 (81%) of the cases were positive for the HBV 1762T/1764A mutation compared with 250 (40%) of the controls. The matched preserving OR of 6.72 (95% CI: 4.66 to 9.68) strongly indicated that cases were significantly more probably than controls to have the mutation. Plasma levels of DNA harboring the HBV mutation were on average 15-fold higher in cases compared with controls (P < 0.001). Most strikingly, the level of the mutation in the 20 controls who later developed and died of HCC were on average 274-fold higher than controls who did not develop HCC. Thus, within this cohort of HBsAg carriers at high risk of developing HCC, individuals positive for the HBV 1762T/1764A mutation at enrollment were substantially more probably to subsequently develop HCC, with a higher concentration of the mutation in plasma enhancing predisposition for cancer development.
doi:10.1093/carcin/bgr055
PMCID: PMC3106439  PMID: 21474708
6.  Sleep and Fatigue Symptoms in Children and Adolescents With CKD: A Cross-sectional Analysis From the Chronic Kidney Disease in Children (CKiD) Study 
Background
Although symptoms of sleepiness and fatigue are common among adults with Chronic Kidney Disease (CKD), little is known about the prevalence of these symptoms in children with CKD.
Study Design
Cross-sectional analysis within a cohort study.
Setting & Participants
We describe the frequency and severity of sleep problems and fatigue, and we assess the extent of their association with measured glomerular filtration rate (mGFR) and Health-Related Quality of Life (HRQOL) among 301 participants of the Chronic Kidney Disease in Children cohort.
Outcomes and Measurements
Sleep and fatigue-related items from the Pediatric Quality of Life Inventory 4.0 Generic Scales and the CKD-related Symptoms List were used.
Results
Median mGFR was 42.0 ml/min/1.73m2 (25th–75th percentiles, 31.2–53.2) [EF1]and median age was 13.9 years (25th–75th percentiles, 10.8–16.2). Children with mGFR 40-<50, 30-<40, or <30 had 2.07 (95% CI, 1.05–4.09), 2.35 (95% CI 1.17, 4.72) and 2.59 (95% CI 1.15, 5.85) higher odds of having more severe parent reports of low energy than children with mGFR ≥50. Compared to participants with mGFR ≥50, those with mGFR <30 had 3.92 (95% CI 1.37, 11.17) higher odds of reporting more severe weakness, and those with mGFR 40-<50 had 2.95 (95% CI 1.26, 6.88) higher odds of falling asleep during the day. Low energy, trouble sleeping and weakness were associated with lower HRQOL scores.
Limitations
Symptoms of sleep and fatigue represent the child or parent’s perception of symptom severity, while individual items can lead to imprecise measurements of sleep and fatigue.
Conclusions
Lower mGFR was associated with increased weakness, low energy, and daytime sleepiness. Furthermore, a strong association between trouble sleeping, low energy and weakness with decrements in overall HRQOL was observed. Detection and treatment of poor sleep and fatigue may improve the development and HRQOL of children and adolescents with CKD.
doi:10.1053/j.ajkd.2009.09.021
PMCID: PMC2814922  PMID: 20034719
children; adolescents; chronic kidney disease; sleep; fatigue; glomerular filtration rate; health-related quality of life
7.  Relationship of Injection Drug Use, Antiretroviral Therapy Resistance, and Genetic Diversity in the HIV-1 pol Gene 
Objectives
To determine if a history of injection drug use influences genotypic PI resistance to antiretroviral agents..
Methods
We assessed the presence of resistance mutations in PI-naive injection drug users (IDUs) and non-IDUs participating in the Women’s Interagency HIV Study. Eighteen HIV-infected participants who reported injection drug use prior to study enrollment and 32 HIV-infected non-IDUs contributed a total of 34 and 65 person-visits, respectively to analyses.
Results
Based on data from multiple clones obtained from different time points from each individual we determined that primary PI resistance mutations were more frequent among person-visits contributed by IDUs (24%) than non-IDUs (8%, p=0.05). While neither reached statistical significance, diversity was higher within the protease region among study visits carrying PI resistant clones at both the nucleotide level (2.66 vs. 2.35; p=0.08) and at the amino acid level (1.60 vs. 1.32; p=0.23). Most of the primary resistance mutations could not be detected using the standard population sequencing employed in the clinical setting. Five of six individuals in whom clones encoding PI resistance mutations were identified failed PI-containing HAART within 12 months of therapy initiation.
Conclusions
Our findings indicate that more aggressive sampling for resistance mutations among viral clones prior to HAART initiation might permit selection of more effective treatment, particularly in IDUs.
doi:10.1097/QAI.0b013e318198a619
PMCID: PMC2937199  PMID: 19214121
Injection drug use; antiretroviral therapy; genotypic resistance; HIV; clonal sequencing; population sequencing
8.  Association of hepatitis C virus and HIV infection with subclinical atherosclerosis in the women’s interagency HIV study 
AIDS (London, England)  2009;23(13):1781-1784.
Whether hepatitis C virus coinfection might accelerate atherosclerosis in HIV-infected individuals is unclear. We examined the relationship of HIV and hepatitis C virus with carotid artery intima media thickness and the presence of carotid plaques in the Women’s Interagency HIV Study. Hepatitis C virus infection was not associated with greater carotid artery intima media thickness after adjustment for demographic and traditional cardiovascular risk factors. Further follow-up is needed to clarify whether HIV/hepatitis C virus coinfection may be associated with a greater risk of carotid plaque.
doi:10.1097/QAD.0b013e32832d7aa8
PMCID: PMC2847440  PMID: 19553807
9.  Antiretroviral Therapy Exposure and Insulin Resistance in the Women’s Interagency HIV Study 
Background
Evidence suggesting an increased risk of cardiovascular disease in HIV-infected individuals has heightened the need to understand the relation of HIV infection, antiretroviral therapy use, and non–HIV-related factors with insulin resistance (IR).
Methods
Prospective study of 1614 HIV-infected and 604 HIV-uninfected participants from the Women’s Interagency HIV Study between October 2000 and March 2007. Homeostasis model assessment (HOMA)–estimated IR at 11,019 semiannual visits.
Results
HIV-infected women reporting highly active antiretroviral therapy (HAART) had higher median HOMA than HIV-uninfected women {1.20 [95% confidence interval (CI): 1.11 to 1.30] times higher for those reporting protease inhibitor–containing HAART; 1.10 (95% CI: 1.01 to 1.20) times higher for those reporting non–protease inhibitor–containing HAART}. Among HIV-infected, cumulative exposure to nucleoside reverse transcriptase inhibitors (NRTIs) of >3 years was associated with HOMA 1.13 (95% CI: 1.02 to 1.25) times higher than the HOMA without any cumulative NRTI exposure. Cumulative exposure to the NRTI stavudine of >1 year was associated with HOMA 1.15 (95% CI: 1.05 to 1.27) times higher than the HOMA without any cumulative stavudine use. Family history of diabetes, hepatitis C virus seropositivity, higher body mass index, or reporting menopause was associated with higher HOMA.
Conclusions
Longer cumulative exposure to NRTI; in particular, stavudine is associated with greater IR in HIV-infected women.
PMCID: PMC2889144  PMID: 19186350
antiretroviral therapy; HIV; HOMA; insulin resistance; nucleoside reverse transcriptase inhibitor; protease inhibitor
10.  Association of Child Care Burden and Household Composition with Adherence to Highly Active Antiretroviral Therapy in the Women's Interagency HIV Study 
AIDS Patient Care and STDs  2009;23(4):289-296.
Abstract
Our objective was to describe the association that childcare burden, household composition, and health care utilization have with adherence to highly active antiretroviral therapy (HAART) among women in the United States. The primary outcome was 95% or more adherence to HAART evaluated at 10,916 semiannual visits between October 1998 and March 2006 among 1419 HIV-infected participants enrolled in the Women's Interagency HIV Study. HAART adherence levels of 95% or more were reported at 76% of the semiannual visits. At only 4% of the person-visits did women report either quite a bit or extreme difficulty in caring for child; at 52% of the person-visits women reported at least one child 18 years of age or older living in the household. We found a one-unit increase in the difficulty in caring for children (childcare burden was assessed on a 5-point scale: not difficult [1] to extremely difficult [5]) was associated with a 6% decreased odds of 95% or more HAART adherence (adjusted odds ratio [OR] = 0.94; p = 0.07). Each additional child 18 years of age or less living in the household was associated with an 8% decreased odds of 95% or more adherence (adjusted OR = 0.92, p = 0.03). Both the number and type of adult living in the household, as well as health care utilization were not associated with HAART adherence. Greater child care burden and number of children 18 years old or younger living in household were both inversely associated with HAART adherence. Assessing patients' difficulties in caring for children and household composition are important factors to consider when addressing adherence to HAART.
doi:10.1089/apc.2008.0161
PMCID: PMC2674283  PMID: 19243274
11.  Multiple-infection and recombination in HIV-1 within a longitudinal cohort of women 
Retrovirology  2009;6:54.
Background
Recombination between strains of HIV-1 only occurs in individuals with multiple infections, and the incidence of recombinant forms implies that multiple infection is common. Most direct studies indicate that multiple infection is rare. We determined the rate of multiple infection in a longitudinal study of 58 HIV-1 positive participants from The Women's Interagency HIV Study with a richer sampling design than previous direct studies, and we investigated the role of recombination and sampling design on estimating the multiple infection rate.
Results
40% of our sample had multiple HIV-1 infections. This rate of multiple infection is statistically consistent with previous studies once differences in sampling design are taken into account. Injection drug use significantly increased the incidence of multiple infections. In general there was rapid elimination of secondary strains to undetectable levels, but in 3 cases a superinfecting strain displaced the initial infecting strain and in two cases the strains coexisted throughout the study. All but one secondary strain was detected as an inter- and/or intra-genic recombinant. Injection drug use significantly increased the rate of observed recombinants.
Conclusion
Our multiple infection rate is consistent with rates estimated from the frequency of recombinant forms of HIV-1. The fact that our results are also consistent with previous direct studies that had reported a much lower rate illustrates the critical role of sampling design in estimating this rate. Multiple infection and recombination significantly add to the genetic diversity of HIV-1 and its evolutionary potential, and injection drug use significantly increases both.
doi:10.1186/1742-4690-6-54
PMCID: PMC2700066  PMID: 19493346
12.  Association of Child Care Burden and Household Composition with Adherence to Highly Active Antiretroviral Therapy in the Women’s Interagency HIV Study 
AIDS patient care and STDs  2009;23(4):289-296.
Our objective was to describe the association that childcare burden, household composition, and health care utilization have with adherence to highly active antiretroviral therapy (HAART) among women in the United States. The primary outcome was 95% or more adherence to HAART evaluated at 10,916 semiannual visits between October 1998 and March 2006 among 1419 HIV-infected participants enrolled in the Women’s Interagency HIV Study. HAART adherence levels of 95% or more were reported at 76% of the semiannual visits. At only 4% of the person-visits did women report either quite a bit or extreme difficulty in caring for child; at 52% of the person-visits women reported at least one child 18 years of age or older living in the household. We found a one-unit increase in the difficulty in caring for children (childcare burden was assessed on a 5-point scale: not difficult [1] to extremely difficult [5]) was associated with a 6% decreased odds of 95% or more HAART adherence (adjusted odds ratio [OR]=0.94; p=0.07). Each additional child 18 years of age or less living in the household was associated with an 8% decreased odds of 95% or more adherence (adjusted OR=0.92, p=0.03). Both the number and type of adult living in the household, as well as health care utilization were not associated with HAART adherence. Greater child care burden and number of children 18 years old or younger living in household were both inversely associated with HAART adherence. Assessing patients’ difficulties in caring for children and household composition are important factors to consider when addressing adherence to HAART.
doi:10.1089/apc.2008.0161
PMCID: PMC2674283  PMID: 19243274
13.  ASSOCIATION OF COMPLEMENTARY AND ALTERNATIVE MEDICINE USE WITH HIGHLY ACTIVE ANTIRETROVIRAL THERAPY INITIATION 
Objective
To assess whether complementary and alternative medicine (CAM) use is associated with the timing of highly active antiretroviral therapy (HAART) initiation among human immunodeficiency virus (HIV)–infected participants of the Women’s Interagency HIV Study.
Study Methods
Prospective cohort study between January 1996 and March 2002. Differences in the cumulative incidence of HAART initiation were compared between CAM users and non–CAM users using a logrank test. Cox regression model was used to assess associations of CAM exposures with time to HAART initiation.
Main Outcome and Exposures
Study outcome was time from January 1996 to initiation of HAART. Primary exposure was use of any CAM modality before January 1996, and secondary exposures included the number and type of CAM modalities used (ingestible CAM medication, body practice, or spiritual healing) during the same period.
Results
One thousand thirty-four HIV-infected women contributed a total of 4987 person-visits during follow-up. At any time point, the cumulative incidence of HAART initiation among CAM users was higher than that among non–CAM users. After adjustment for potential confounders, those reporting CAM use were 1.34 times (95% confidence interval: 1.09, 1.64) more likely to initiate HAART than non–CAM users.
Conclusion
Female CAM users initiated HAART regimens earlier than non–CAM users. Initiation of HAART is an important clinical marker, but more research is needed to elucidate the role specific CAM modalities play in HIV disease progression.
PMCID: PMC2651402  PMID: 18780580
14.  Association Between Living With Children and Adherence to Highly Active Antiretroviral Therapy in the Women’s Interagency HIV Study 
Pediatrics  2008;121(4):e787-e793.
OBJECTIVE
The purpose of this work was to evaluate whether living with children adversely affects adherence to highly active antiretroviral therapy in HIV-infected women.
PARTICIPANTS AND METHODS
We conducted a prospective cohort study between October 1998 and September 2005. The study outcome was ≥95% adherence to highly active antiretroviral therapy evaluated at 5832 semiannual visits among 1366 HIV-infected women in the Women’s Interagency HIV Study. The primary exposure defined at the visit immediately before outcome ascertainment was the number of children ≤18 years of age reported living in the household.
RESULTS
The percentage of women who reported ≥2 children in the household who also reported ≥95% adherence ranged from 68% to 75% compared with adherence when either 1 child or no children were reported. Each additional child reported living in the household was associated with a 6% decrease in the odds of ≥95% adherence.
CONCLUSION
The impact of living with a child on the ability to take medications by HIV-infected women has not been examined thoroughly. Our data suggest that adherence to highly active antiretroviral therapy is inversely associated with the number of children living in the household.
doi:10.1542/peds.2007-1586
PMCID: PMC2651400  PMID: 18381507
adherence; children; HAART; HIV
15.  Serological Detection of Human Papillomavirus Type 16 Infection in Human Immunodeficiency Virus (HIV)-Positive and High-Risk HIV-Negative Women 
Clinical and Vaccine Immunology  2006;13(4):511-519.
Serial measurement of antibodies has not been used to provide evidence of active viral replication of human papillomavirus (HPV). Serum specimens from sequential study visits contributed by 642 human immunodeficiency virus (HIV)-positive and 116 HIV-negative participants enrolled in the Women's Interagency HIV Study were used to detect significant rises in HPV type 16 (HPV-16) antibody levels. Factors associated with a significant rise were identified using multivariable logistic regression models with generalized estimating equations. Among HIV-positive women, 8.3% of 1,997 pairs showed antibody rises, compared to 6.1% of 361 pairs among HIV-negative women (P = 0.191). For HIV-positive women, rises were associated with current (odds ratio [OR], 23.4; P < 0.001) or past (OR, 8.9; P < 0.001) HPV-16 infection relative to never being HPV-16 infected and with CD4+ cell counts (OR per 100-cell increase, 0.8; P < 0.001) but not with sexual behavior. For HIV-negative women, rises were associated with past (OR, 10.9; P = 0.033) HPV-16 infection relative to no HPV-16, current cigarette smoking (OR, 5.0; P = 0.029) relative to no smoking history, and having 6 to 10 lifetime sexual partners compared to 0 to 5 partners (OR, 9.9; P = 0.036). Serial measurement of HPV-16 serum antibodies is a useful tool for identifying active HPV-16 viral replication. Rises among HIV-positive women may more often result from reactivation of a latent HPV infection in the context of HIV-induced immunosuppression, while rises among HIV-negative women may more often result from reinfection with HPV.
doi:10.1128/CVI.13.4.511-519.2006
PMCID: PMC1459636  PMID: 16603621

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