A randomized control trial of high-dose micronutrient-antioxidant supplementation in healthy persons with untreated HIV infection.

BACKGROUND: Although micronutrient and antioxidant supplementation are widely used by persons with human immunodeficiency virus (HIV), a therapeutic role beyond recommended daily allowances (RDA) remains unproven. An oral high-dose micronutrient and antioxidant supplement (Treatment) was compared to an RDA supplement (Control) for time to progressive immunodeficiency or initiation of antiretroviral therapy (ART) in people living with HIV (PLWH). METHODS: This study was a randomized, double-blind, placebo-controlled multicenter clinical trial. PLWH were recruited from Canadian HIV Trials Network sites, and followed quarterly for two years. Eligible participants were asymptomatic, antiretroviral treatment (ART)-naïve, HIV-seropositive adults with a CD4 T lymphocyte count (CD4 count) between 375-750 cells/µL. Participants were randomly allocated 1:1 to receive Treatment or Control supplements. The primary outcome was a composite of time-to-first of confirmed CD4 count below 350 cells/µL, initiation of ART, AIDS-defining illness or death. Primary analysis was by intention-to-treat. Secondary outcomes included CD4 count trajectory from baseline to ART initiation or two years. A Data and Safety Monitoring Board reviewed the study for safety, recruitment and protocol adherence every six months. RESULTS: Of 171 enrolled participants: 66 (38.6%) experienced a primary outcome: 27 reached a CD4 count below 350 cells/µL, and 57 started ART. There was no significant difference in time-to-first outcome between groups (Hazard Ratio = 1.05; 95%CI: 0.65, 1.70), or in time to any component outcome. Using intent-to-treat censoring, mean annualized rates of CD4 count decline were -42.703 cells/µL and -79.763 cells/µL for Treatment and Control groups, with no statistical difference in the mean change between groups (-37.06 cells/µL/52 weeks, 95%CI: (-93.59, 19.47); p = 0.1993). Accrual was stopped at 171 of the 212 intended participants after an interim analysis for futility, although participant follow-up was completed. CONCLUSIONS: In ART-naïve PLWH, high-dose antioxidant, micronutrient supplementation compared to RDA supplementation had no significant effect on disease progression or ART initiation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00798772.

The importance of motherhood in HIV-positive women of reproductive age in Ontario, Canada.

Motherhood is personally, culturally, and historically rooted. Recent publications have focused on medical issues related to pregnancy and HIV, with attention on fetal well-being. There is limited literature on the importance of motherhood for HIV-positive women. Our study's purpose was to investigate the importance of motherhood among HIV-positive women of reproductive age in Ontario, Canada and to analyze the correlates thereof. We present our findings using a secondary analysis of cross-sectionally collected data from a study assessing fertility desires and intentions of HIV-positive women. The sub-analysis's outcome of interest was based on the question: "Being a mother is important to me" with a 5-point Likert scale that was dichotomized into strongly agree/agree vs. neutral/disagree/strongly disagree. Logistic regression models were fit to calculate unadjusted and adjusted odds ratios (ORs) for significant correlates. Of the 497 respondents, median age was 38 (interquartile range [IQR] 32-43), 46% were African, 74% had given birth, and 57% intended to give birth. A total of 452 (91%) agreed (N = 75) or strongly agreed (N = 377) that being a mother was important to them. Age less than 40 years (OR 3.0; 95% confidence interval [CI] 1.6-5.7, African ethnicity (OR 9.2; 95% CI 3.2-26.3), immigration within 10 years (OR 19.6, 95% CI 4.6-83.1), and partner or family desire for a pregnancy (OR 3.3; 95% CI 1.5-7.3) were significant correlates of the importance of motherhood in a univariate analysis. Importance of motherhood was associated with desire (OR 6.2, 95% CI 3.1-12.3) and intention to give birth (OR 6.9, 95% CI 3.1-15.2), and previous birth (OR 8.5, 95% CI 4.2-16.8). In the multivariable model, the significant correlates were of age less than 40 years (OR 3.9; 95% CI 1.8-8.4), immigration within 10 years (OR 14.1; 95% CI 3.2-61.5), and having previously given birth (OR 11.2; 95% CI 5.1-24.4). The majority of women felt strongly that motherhood was important to them particularly among younger women, recent immigrants, and women who were mothers.

Self-Reported Preconception Care of HIV-Positive Women of Reproductive Potential: A Retrospective Study.

OBJECTIVES: We determined the proportion and correlates of self-reported pregnancy planning discussions (that is preconception counseling) that HIV-positive women reported to their family physicians (FPs), HIV specialists, and obstetrician/gynecologists (OB/Gyns). METHODS: In a cross-sectional substudy, HIV-positive women of reproductive potential were asked whether their care providers discussed pregnancy planning. Logistic regression was used to calculate odds ratios for the correlates of preconception counseling. RESULTS: A total of 431 eligible participants (median age 38, interquartile range = 32-43) reported having discussion with a physician (92% FP, 96% HIV specialists, and 45% OB/Gyns). In all, 34%, 41%, and 38% had their pregnancy planning discussion with FP, HIV specialist, and Ob/Gyns, respectively; 51% overall. In the multivariable model, significant correlates of preconception counseling were age (P = .02), marital status (P < .01), number of years living in Canada (P < .001), and age of youngest child (P < .01). CONCLUSIONS: Preconception care in our cohort was suboptimal. We recommend that counseling on healthy preconception should be part of routine HIV care.

Fertility desires and intentions of HIV-positive women of reproductive age in Ontario, Canada: a cross-sectional study.

BACKGROUND: Improvements in life expectancy and quality of life for HIV-positive women coupled with reduced vertical transmission will likely lead numerous HIV-positive women to consider becoming pregnant. In order to clarify the demand, and aid with appropriate health services planning for this population, our study aims to assess the fertility desires and intentions of HIV-positive women of reproductive age living in Ontario, Canada. METHODOLOGY/PRINCIPAL FINDINGS: A cross-sectional study with recruitment stratified to match the geographic distribution of HIV-positive women of reproductive age (18-52) living in Ontario was carried out. Women were recruited from 38 sites between October 2007 and April 2009 and invited to complete a 189-item self-administered survey entitled "The HIV Pregnancy Planning Questionnaire" designed to assess fertility desires, intentions and actions. Logistic regression models were fit to calculate unadjusted and adjusted odds ratios of significant predictors of fertility intentions. The median age of the 490 participating HIV-positive women was 38 (IQR, 32-43) and 61%, 52%, 47% and 74% were born outside of Canada, living in Toronto, of African ethnicity and currently on antiretroviral therapy, respectively. Of total respondents, 69% (95% CI, 64%-73%) desired to give birth and 57% (95% CI, 53%-62%) intended to give birth in the future. In the multivariable model, the significant predictors of fertility intentions were: younger age (age<40) (p<0.0001), African ethnicity (p<0.0001), living in Toronto (p = 0.002), and a lower number of lifetime births (p = 0.02). CONCLUSIONS/SIGNIFICANCE: The proportions of HIV-positive women of reproductive age living in Ontario desiring and intending pregnancy were higher than reported in earlier North American studies. Proportions were more similar to those reported from African populations. Healthcare providers and policy makers need to consider increasing services and support for pregnancy planning for HIV-positive women. This may be particularly significant in jurisdictions with high levels of African immigration.

Serum sickness-like reaction possibly associated with meropenem use.

Serum sickness-like reactions most commonly occur secondary to drug administration. We describe a serum sickness-like reaction that was possibly associated with meropenem therapy.