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Effect of micronutrient supplementation on disease progression in asymptomatic, antiretroviral-naive, HIV-infected adults in Botswana: a randomized clinical trial.

ABSTRACT: Micronutrient deficiencies occur early in human immunodeficiency virus (HIV) infection, and supplementation with micronutrients may be beneficial; however, its effectiveness has not been investigated early in HIV disease among adults who are antiretroviral therapy (ART) naive.To investigate whether long-term micronutrient supplementation is effective and safe in delaying disease progression when implemented early in adults infected with HIV subtype C who are ART-naive.Randomized clinical trial of supplementation with either daily multivitamins (B vitamins and vitamins C and E), selenium alone, or multivitamins with selenium vs placebo in a factorial design for 24 months. The study was conducted in 878 patients infected with HIV subtype C with a CD4 cell count greater than 350/?L who were not receiving ART at Princess Marina Hospital in Gaborone, Botswana, between December 2004 and July 2009.Daily oral supplements of B vitamins and vitamins C and E, selenium alone, or multivitamins plus selenium, compared with placebo.Reaching a CD4 cell count less than 200/?L until May 2008; after this date, reaching a CD4 cell count of 250/?L or less, consistent with the standard of care in Botswana for initiation of ART at the time of the study.There were 878 participants enrolled and randomized into the study. All participants were ART-naive throughout the study. In intent-to-treat analysis, participants receiving the combined supplement of multivitamins plus selenium had a significantly lower risk vs placebo of reaching CD4 cell count 250/?L or less (adjusted hazard ratio [HR], 0.46; 95% CI, 0.25-0.85; P?=?.01; absolute event rate [AER], 4.79/100 person-years; censoring rate, 0.92; 17 events; placebo AER, 9.22/100 person-years; censoring rate, 0.85; 32 events). Multivitamins plus selenium in a single supplement, vs placebo, also reduced the risk of secondary events of combined outcomes for disease progression (CD4 cell count ?250/?L, AIDS-defining conditions, or AIDS-related death, whichever occurred earlier [adjusted HR, 0.56; 95% CI, 0.33-0.95; P?=?.03; AER, 6.48/100 person-years; censoring rate, 0.90; 23 events]). There was no effect of supplementation on HIV viral load. Multivitamins alone and selenium supplementation alone were not statistically different from placebo for any end point. Reported adverse events were adjudicated as unlikely to be related to the intervention, and there were no notable differences in incidence of HIV-related and health-related events among study groups.In ART-naive HIV-infected adults, 24-month supplementation with a single supplement containing multivitamins and selenium was safe and significantly reduced the risk of immune decline and morbidity. Micronutrient supplementation may be effective when started in the early stages of HIV disease.

SUBMITTER: Baum MK

PROVIDER: S-EPMC4347896 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Effect of micronutrient supplementation on disease progression in asymptomatic, antiretroviral-naive, HIV-infected adults in Botswana: a randomized clinical trial.

Baum Marianna K MK Campa Adriana A Lai Shenghan S Sales Martinez Sabrina S Tsalaile Lesedi L Burns Patricia P Farahani Mansour M Li Yinghui Y van Widenfelt Erik E Page John Bryan JB Bussmann Hermann H Fawzi Wafaie W WW Moyo Sikhulele S Makhema Joseph J Thior Ibou I Essex Myron M Marlink Richard R

JAMA 20131101 20

<h4>Importance</h4>Micronutrient deficiencies occur early in human immunodeficiency virus (HIV) infection, and supplementation with micronutrients may be beneficial; however, its effectiveness has not been investigated early in HIV disease among adults who are antiretroviral therapy (ART) naive.<h4>Objective</h4>To investigate whether long-term micronutrient supplementation is effective and safe in delaying disease progression when implemented early in adults infected with HIV subtype C who are ...[more]

PMID: 24281460

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Project description:ObjectivesThere are limited data on the prevalence of doravirine (DOR)-associated drug resistance mutations in people with HIV (PWH) in Botswana. This cross-sectional, retrospective study aimed to explore the prevalence of DOR-associated resistance mutations among ART-naïve and -experienced PWH in Botswana enrolled in the population-based Botswana Combination Prevention Project (BCPP).MethodsA total of 6078 HIV-1C pol sequences were analysed for DOR-associated resistance mutations using the Stanford HIV drug resistance database, and their levels were predicted according to the Stanford DRM penalty scores and resistance interpretation. Virologic failure was defined as HIV-1 RNA load (VL) >400 copies/mL.ResultsAmong 6078 PWH, 5999 (99%) had known ART status, and 4529/5999 (79%) were on ART at time of sampling. The suppression rate among ART-experienced was 4517/4729 (96%). The overall prevalence of any DOR-associated resistance mutations was 181/1473 (12.3% [95% confidence interval {CI}: 10.7-14.1]); by ART status: 42/212 (19.8% [95% CI: 14.7-25.4]) among ART-failing individuals (VL ≥400 copies/mL) and 139/1261 (11.0% [95% CI: 9.3-12.9]) among ART-naïve individuals (P < 0.01). Intermediate DOR-associated resistance mutations were observed in 106/1261 (7.8% [95% CI: 6.9-10.1]) in ART-naïve individuals and 29/212 (13.7% [95% CI: 9.4-8.5]) among ART-experienced participants (P < 0.01). High-level DOR-associated resistance mutations were observed in 33/1261 (2.6% [95% CI: 1.8-3.7]) among ART-naïve and 13/212 (6.1% [95% CI: 3.6-10.8]) among ART-failing PWH (P < 0.01). PWH failing ART with at least one EFV/NVP-associated resistance mutation had high prevalence 13/67 (19.4%) of high-level DOR-associated resistance mutations.ConclusionDOR-associated mutations were rare (11.0%) among ART-naive PWH but present in 62.7% of Botswana individuals who failed NNRTI-based ART with at least one EFV/NVP-associated resistance mutation. Testing for HIV drug resistance should underpin the use of DOR in PWH who have taken first-generation NNRTIs.

Project description:IntroductionThe MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance (RDA) vitamins in slowing HIV immune deficiency progression in ART-naïve people with HIV infection.ObjectiveWe planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates, as well as tolerance and adherence to study interventions.MethodsParticipants receive eight capsules twice daily of 1) high-dose or 2) RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression, safety and tolerability. Regression analysis was used to identify correlates of micronutrient levels at baseline. Adherence was measured by residual pill count, self-report using the General Treatment Scale (GTS) and short-term recall HIV Adherence Treatment Scale (HATS).ResultsPrior micronutrient supplementation (within 30 days) was 27% at screening and 10% of study population, and was not correlated with baseline micronutrient levels. Low levels were frequent for carotene (24%<1 nmol/L), vitamin D (24%<40 nmol/L) and serum folate (20%<15 nmol/L). The proportion with B12 deficiency (<133 pmol/L) was 2.4%. Lower baseline levels of B12 correlated lower baseline CD4 count (r?=?0.21, p?=?0.02) with a 21 pmol/L reduction in B12 per 100 cells/µL CD4. Vitamin D levels were higher in men (p<0.001). After a median follow-up of 1.63 years, there were 19 (15%) early withdrawals from the study treatment. Mean treatment adherence using pill count was 88%. Subjective adherence by the GTS was 81% and was moderately but significantly correlated with pill count (r?=?0.29, p<0.001). Adherence based on short-term recall (HATS) was >80% in 75% of participants.ConclusionMicronutrient levels in asymptomatic HIV+ persons are in keeping with population norms, but micronutrient deficiencies are frequent. Adherence levels are high, and will permit a valid evaluation of treatment effects.Trial registrationClinicalTrials.gov NCT00798772.

Project description:Both under- and over-nutrition may occur among human immunodeficiency virus (HIV)-infected individuals and impact on the course of the acquired immune deficiency syndrome (AIDS) and its management due to the close interaction between immunity and nutrition. We investigated occurrence of undernutrition, excess weight and lipid abnormalities among antiretroviral naïve HIV-infected adults in Addis Ababa, Ethiopia.A cross-sectional study on 594 antiretroviral therapy (ART) naïve HIV-infected adults was conducted in four hospitals in Addis Ababa from February to September 2013. Hematological parameters (CD4+ T cell count and hemoglobin concentration), fasting serum glucose, total cholesterol (TC) and triglycerides (TG) were determined. Information on socio-demographic, anthropometric and World Health Organization (WHO) clinical stages was collected from patient clinical records, and triangulated by structured questionnaire. Height and weight measurements were taken and body mass index (BMI), undernutrition (BMI <18.5 kg/m2) and excess weight (BMI ?25 kg/m2) determined. Statistical comparisons were made to identify significant factors associated with nutritional status and lipid profiles.The prevalence of undernutrition was 15.1%, and the prevalence of excess weight was 22.1%, including 5.4% who were obese. The prevalence of hypercholesterolemia was 16.6% and it was higher in women (18.9%) than in men (11.0%) (p<0.05). However, the prevalence of hypertriglyceridemia was 29.8%. There was significant positive Spearman correlation between CD4+ T cell count and serum TC (r = 0.210, p<0.001), but no correlation was observed between CD4+ T cell count and TG (r = -0.007, p>0.05). Age categories 30-39 and 40-79, and WHO clinical stages III/IV for undernutrition; age categories 30-39 and 40-79, WHO clinical stages III/IV and TC ?200 mg/dL for excess weight; and being female, age categories 30-39 and 40-79, and hypertriglyceridemia for hypercholesterolemia were found to be independent predictors by binomial logistic regression analysis.Undernutrition, excess weight, hypercholesterolemia and hypertriglyceridemia were variably prevalent in ART naïve HIV-infected populations. This emphasizes the need for targeted nutritional programs as an integral part of HIV/AIDS care. Lipid levels need to be monitored regularly in patients whether on or off ART. In addition, improvement on household income and positive change in lifestyle and/or nutritional treatment to reduce morbidity and mortality are necessary interventions in HIV/AIDs patient management.

Dataset Information

Effect of micronutrient supplementation on disease progression in asymptomatic, antiretroviral-naive, HIV-infected adults in Botswana: a randomized clinical trial.

Publications

Effect of micronutrient supplementation on disease progression in asymptomatic, antiretroviral-naive, HIV-infected adults in Botswana: a randomized clinical trial.

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