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2.  Interleukin 10 Responses Are Associated With Sustained CD4 T-Cell Counts in Treated HIV Infection 
The Journal of Infectious Diseases  2012;206(5):780-789.
Background.Inflammation persists in treated human immunodeficiency virus (HIV) infection and may contribute to an increased risk for non–AIDS-related pathologies. We investigated the correlation of cytokine responses with changes in CD4 T-cell levels and coinfection with hepatitis C virus (HCV) during highly active antiretroviral treatment (HAART).
Methods.A total of 383 participants in the Women's Interagency HIV Study (212 with HIV monoinfection, 56 with HCV monoinfection, and 115 with HIV/HCV coinfection) were studied. HIV-infected women had <1000 HIV RNA copies/mL, 99.7% had >200 CD4 T cells/μL; 98% were receiving HAART at baseline. Changes in CD4 T-cell count between baseline and 2–4 years later were calculated. Peripheral blood mononuclear cells (PBMCs) obtained at baseline were used to measure interleukin 1β (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), interleukin 12 (IL-12), and tumor necrosis factor α (TNF-α) responses to Toll-like receptor (TLR) 3 and TLR4 stimulation.
Results.Undetectable HIV RNA (<80 copies/mL) at baseline and secretion of IL-10 by PBMCs were positively associated with gains in CD4 T-cell counts at follow-up. Inflammatory cytokines (IL-1β, IL-6, IL-12, and TNF-α) were also produced in TLR-stimulated cultures, but only IL-10 was significantly associated with sustained increases in CD4 T-cell levels. This association was significant only in women with HIV monoinfection, indicating that HCV coinfection is an important factor limiting gains in CD4 T-cell counts, possibly by contributing to unbalanced persistent inflammation.
Conclusions.Secreted IL-10 from PBMCs may balance the inflammatory environment of HIV, resulting in CD4 T-cell stability.
doi:10.1093/infdis/jis380
PMCID: PMC3491747  PMID: 22693231
3.  Isoflavone Soy Protein Supplementation and Atherosclerosis Progression in Healthy Postmenopausal Women: A Randomized Controlled Trial 
Background and Purpose
Although epidemiological and experimental studies suggest that dietary intake of soy may be cardioprotective, use of isoflavone soy protein (ISP) supplementation as a primary preventive therapy remains unexplored. We determined whether ISP reduces subclinical atherosclerosis assessed as carotid artery intima-media thickness (CIMT) progression.
Methods
In a double-blind, placebo-controlled trial, 350 postmenopausal women 45–92 years of age without diabetes and cardiovascular disease (CVD) were randomized to 2 evenly divided daily doses of 25 g soy protein containing 91 mg aglycon isoflavone equivalents or placebo for 2.7-years.
Results
Overall, mean (95% confidence interval) CIMT progression rate was 4.77(3.39–6.16) μm/year in the ISP group and 5.68(4.30–7.06) μm/year in the placebo group. Although CIMT progression was reduced on average by 16% in the ISP group relative to the placebo group, this treatment effect was not statistically significant (p=0.36). Among the subgroup of women who were randomized within 5 years of menopause, ISP participants had on average a 68% lower CIMT progression rate than placebo participants 2.16(−1.10–5.43) vs. 6.79(3.56–10.01) μm/year, p=0.05). ISP supplementation had a null effect on women who were >5 years beyond menopause when randomized. There were no major adverse events from ISP supplementation.
Conclusion
ISP supplementation did not significantly reduce subclinical atherosclerosis progression in postmenopausal women. Subgroup analysis suggest that ISP supplementation may reduce subclinical atherosclerosis in healthy young (median age, 53 years) women at low-risk for CVD who were <5 years postmenopausal. These first trial results of their kind warrant further investigation.
doi:10.1161/STROKEAHA.111.620831
PMCID: PMC3202054  PMID: 21903957
Atherosclerosis; Cardiovascular disease; Intima-media thickness; Isoflavones; Menopause; Soy; Women
4.  The Impact of the AIDS Drug Assistance Program (ADAP) on Use of Highly Active Antiretroviral and Antihypertensive Therapy among HIV-Infected Women 
Objectives
To evaluate the association between enrollment into an AIDS Drug Assistance Program (ADAP) and use of highly active antiretroviral therapy (HAART) and antihypertensive therapy.
Methods
Cross-sectional analyses of data were performed on HAART-eligible women enrolled in the California (n=439), Illinois (n=168), and New York (n=487) Women’s Interagency HIV Study (WIHS) sites. A subset of HIV-infected women with hypertension (n=395) was also analyzed. Unadjusted and adjusted backward stepwise elimination logistic regression measured the association between demographic, behavioral, and health service factors and non-use of HAART or antihypertensive medication.
Results
In adjusted analysis of HAART non-use, women without ADAP were significantly more likely not to use HAART (odds ratio [OR] = 2.4, 95% confidence interval [CI] = 1.5–3.7) than women with ADAP. In adjusted analysis of antihypertensive medication non-use, women without ADAP had an increased but not significant odds of antihypertensive medication non-use (OR = 2.4, 95% CI = 0.93–6.0) than women with ADAP.
Conclusions
Government-funded programs for prescription drug coverage, such as ADAP, may play an important role in how HIV-positive women to access and use essential medications for chronic diseases.
doi:10.1097/QAI.0b013e31820a9d04
PMCID: PMC3042745  PMID: 21239994
AIDS; antiretroviral therapy; hypertension; women; healthcare disparity; prescription insurance
5.  Urine accurately reflects circulating isoflavonoids and ascertains compliance during soy intervention 
BACKGROUND
Isoflavonoids (IFLs) may protect against chronic diseases including cancer. IFL exposure is traditionally measured from plasma but the reliability of urine is uncertain. We assessed whether IFL excretion in overnight urine (OU) or spot urine (SU) reliably reflects IFLs in plasma (PL) and the usefulness of the three matrices to determine soy intake compliance.
METHODS
In a randomized, double-blind, placebo-controlled soy intervention trial with 350 postmenopausal women, IFLs (daidzein, genistein, glycitein, equol, O-desmethylangolensin, dihydrodaidzein, dihydrogenistein) were analyzed by LCMS in OU, SU, and PL collected at baseline and every 6 months over 2.5 years.
RESULTS
High between-subjects intraclass correlations between all three matrices (median 0.94) and high between-subjects Pearson correlations (median rOU-PL=0.80; median rSU-PL=0.80; median rOU-SU=0.92) allowed the development of equations to predict IFL values from any of the three matrices. Equations developed from a randomly selected 87% of all available data were valid as high correlations were found on the residual 13% of data between equation-generated and measured IFL values (median rOU-PL=0.86; median rSU-PL=0.78; median rOU-SU=0.84); median absolute IFL differences for OU-PL, SU-PL, and OU-SU were 8.8 nM, 10.3 nM and 0.28 nmol/mg, respectively. All three matrices showed highly significant IFL differences between the placebo and soy intervention group at study end (P<0.0001) and highly significant correlations between IFL values and counted soy doses in the intervention group.
CONCLUSIONS
OU and SU IFL excretion reflect circulating PL IFL levels in healthy postmenopausal women accurately.
IMPACT
Noninvasively-collected urine can be used to reliably determine systemic IFL exposure and soy intake compliance.
doi:10.1158/1055-9965.EPI-10-0116
PMCID: PMC2950801  PMID: 20615889
isoflavonoids; urine; plasma; compliance; soy; intervention; biomarker
6.  Retention and Attendance of Women Enrolled in a Large Prospective Study of HIV-1 in the United States 
Journal of Women's Health  2009;18(10):1627-1637.
Abstract
Objective
The objective was to assess study retention and attendance for two recruitment waves of participants in the Women's Interagency HIV Study (WIHS).
Methods
The WIHS, a prospective study at six clinical centers in the United States, has experienced two phases of participant recruitment. In phase one, women were screened and enrolled at the same time, and in phase two, women were screened and enrolled at separate visits. Compliance with study follow-up was evaluated by examining semiannual study retention and visit attendance.
Results
After 10 study visits, the retention rate in the original recruits (enrolled in 1994–1995) was 83% for the HIV-infected women and 69% for the HIV-uninfected women compared with 86% and 86%, respectively, in the new recruits (enrolled in 2001–2002). In logistic regression analysis of the HIV-infected women, factors associated with early (visits 2 and 3) nonattendance were temporary housing, moderate alcohol consumption, use of crack/cocaine/heroin, having a primary care provider, WIHS site of enrollment, lower CD4 cell count, and higher viral load. Among HIV-uninfected women, the factors associated with early nonattendance were recruitment into the original cohort, household income ≥$12,000 per year, temporary housing, unemployment, use of crack/cocaine/heroin, and WIHS site of enrollment. Factors associated with nonattendance at later visits (7–10) among HIV-infected participants were younger age, white race, not having a primary care provider, not having health insurance, WIHS site of enrollment, higher viral load, and nonattendance at a previous visit. In HIV-uninfected participants, younger age, white race, WIHS site of enrollment, and nonattendance at a previous visit were significantly associated with nonattendance at later visits.
Conclusions
Preventing early loss to follow-up resulted in better study retention early, but late loss to follow-up may require different retention strategies.
doi:10.1089/jwh.2008.1337
PMCID: PMC2825719  PMID: 19788344

Results 1-6 (6)