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Mildronate capsule as the primary drug that inhibits EBOV infection, and are not expected to have a significant effect pharmacy online northern ireland on morbidity or mortality. Pre-exposure prophylaxis (PrEP) is currently used worldwide to prevent HIV infection. While a number of studies in humans demonstrate that PrEP can reduce both the rate of HIV acquisition and the duration of virus shedding, exact mechanism by which PrEP reduces infection rates has not been well understood. Several investigators have suggested that PrEP may enhance the ability of HIV-1 to infect the CD4 + T lymphocytes that respond to ART. However, no conclusive evidence has been obtained to support this contention. This study examines the potential protective role of flavonoid pectin in both HIV-1-infected and uninfected subjects. We hypothesize that pectin reduces the number of CD4 + T lymphocytes that are infected with HIV and that this effect is due to inhibition of viral replication. This would be in contrast to previous studies showing that pectin, like most flavonoids, does not affect the ability of HIV to infect CD4 + T lymphocytes (e.g., Dalla et al., 2003). Materials and Methods Subjects We studied three HIV-1-infected patients and four uninfected controls via in-person interviews and blood samples before after 1 week of pretreatment with either a placebo capsule containing pectin (n = 9) or an active control capsule containing no flavonoid (n = 10). The placebo capsules contained an equal amount of pectin and had a sugar content of 2.5% (w/w) similar to that of a typical chewing gum (3.5% w/w). The active control capsule contained no flavonoid. All subjects received an additional placebo capsule 1 week after the first treatment as a control. Subjects who had already used ART were recruited from a larger population of subjects previously treated with ART, HIV-1 infection confirmed by positive virus tests and CD4 + T cell counts >500 cells/mm3. In addition, eight subjects were enrolled in a clinical trial of pectin for the prevention tuberculosis (Dalla et al., 2003). Study Design All study participants entered a double-blind, randomized, placebo-controlled, phase I clinical trial to compare the safety, immunogenicity, and efficacy of a flavonoid-based HIV-1 preventive drug (flavate, pectin, or a combination) compared with placebo (ClinicalTrials.gov Identifier: NCT01827752). All patients received vaistas mildronate 500mg a single-antigen regimen of the flavonoid-based drug. Interventions and Assessments A single-point study visit was scheduled 1 week after the pretreatment period began. Inpatient and outpatient blood samples were collected at enrollment and again 2 weeks after the first visit, and plasma was collected at both visits. Study participants were evaluated for symptoms of illness and CD4 cell count, participants who were HIV-infected and had a plasma sample available were evaluated at each visit and the end of study. Subjects with HIV-1 infection and CD4 cell count >500 cells/mm3 were randomly assigned to receive either a placebo (n = 9) or an anti-CD3 antibody-based drug (n = 10) in a blinded fashion. HIV-1 infection status was confirmed by negative HIV-1 RNA testing at baseline and after the first visit, by viral load at enrollment and 1 week after the first visit. Data were collected using a computerized, self-reported, questionnaire-based interview and a review of medical files. The clinical-record review board approved study, as did the Institutional Review Board at University of Pittsburgh. All study participants provided written informed consent to participate in the study. Study Site Study sites included the Pittsburgh, PA, Metropolitan University: University Hospital Health Center, the of Pittsburgh Medical and University Florida College of Medicine. Protocols and Statistical Analysis Data were categorized by a multivariable, logistic regression analysis (Excel version 6.0) that controlled for baseline age, sex, HIV-1 serostatus, race, and treatment regimen. We used the following categorical variables: HIV-1 serostatus, treatment regimen, age, race, sex (male or female), and presence of medical conditions. HIV-1 serostatus category included those who were in a stable HIV-1 infection status, those who had recently received ART, those who had previously started ART, and those who had been treated with ART but had not achieved viral suppression. HIV-1 treatment regimen category included those who had started ART as part of the primary HIV therapy regimen, those who had started ART alone, those who used less than 200 mg of ART per week.
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