Abstract:
OBJECTIVES:Despite substantial improvements in HIV outcomes with combination antiretroviral therapy (cART), morbidity and mortality remain above population norms. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Since the microbial environment surrounding a CD4 T cell may influence its development and function, we hypothesize that probiotics provided during cART might reduce inflammation and improve gut immune health in HIV-positive treatment-naïve individuals (PROOV IT I) and individuals with suboptimal CD4 recovery on cART (PROOV IT II). METHODS:These prospective, double-blinded, randomized, placebo-controlled, multicenter pilot studies will assess the impact of the probiotic Visbiome at 900 billion bacteria daily. Forty HIV positive cART-naïve men will be randomized in the PROOV IT I study, coincident with antiretroviral initiation, and be followed for 24 weeks. In PROOV IT II, 36 men on cART, but with a CD4 T-cell count below 350 cells/mm(3) will be followed for 48 weeks. The primary outcome for both studies is the comparison of blood CD8 T-cell immune activation. Secondary analyses will include comparison of blood inflammatory biomarkers, microbial translocation, blood and gut immunology and HIV levels, the bacterial community composition, diet, intestinal permeability, and the safety, adherence and tolerability of the study product. DISCUSSION:These studies will evaluate the ability of probiotics as a safe and tolerable therapeutic intervention to reduce systemic immune activation and to accelerate gut immune restoration in people living with HIV.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
Kim CJ,Walmsley SL,Raboud JM,Kovacs C,Coburn B,Rousseau R,Reinhard R,Rosenes R,Kaul Rdoi
10.1080/15284336.2016.1184827subject
Has Abstractpub_date
2016-07-01 00:00:00pages
147-57issue
4eissn
1528-4336issn
1945-5771journal_volume
17pub_type
临床试验,杂志文章,多中心研究,随机对照试验abstract:UNLABELLED:Patients with prior virologic failure (VF) are at an increased risk of subsequent failure, emergence of resistance, and death. This analysis identifies outcomes and correlates of VF in a high-risk population. METHODS:A5251 was designed to evaluate an enhanced adherence counseling intervention delivered by n...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1080/15284336.2016.1189754
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:To analyze the changes over two decades in HIV-infected pregnant women followed at a highly specialized regional center for antenatal care in southern Italy. METHOD:Since 1985, all HIV-infected pregnant women attending our center have been monitored using progressively updated protocols. RESULTS:By December 2...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0901-36
更新日期:2008-01-01 00:00:00
abstract:PURPOSE:A comprehensive study comparing the costs and efficacies of darunavir/ritonavir 800/100 mg qd and the other ritonavir-boosted (/r) protease inhibitors (PIs) recommended for treatment-naïve individuals with HIV-1 infection would help health care decision makers identify the value of each boosted PI. METHODS:A c...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1103-133
更新日期:2010-05-01 00:00:00
abstract:OBJECTIVES:Antiretroviral regimen switching may be considered for HIV-1-infected, virologically-suppressed patients to enable treatment simplification or improve tolerability, but should be guided by knowledge of pre-existing drug resistance. The current study examined the impact of pre-existing drug resistance mutatio...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1080/15284336.2015.1115585
更新日期:2016-02-01 00:00:00
abstract:OBJECTIVE:To determine the prevalence of CCR5-tropic HIV-1 among treatment-experienced patients in Spain. DESIGN:Epidemiologic, cross-sectional, and non-interventional study between January and June 2008 in HIV-1-infected patients in Spain. METHODS:A total of 485 treatment-experienced patients from across Spainand wi...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1006-394
更新日期:2009-11-01 00:00:00
abstract::AIDS is characterized with immune dysregulation and depletion of CD4+ T cells and increased vulnerability to different pathological conditions, including many dermatoses. The present report describes features of Darier disease (DD) in an HIV-positive patient. The subject of this report was a 45-year old Ghanaian man r...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1201-48
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND:We hypothesized that nitazoxanide (NTZ) added to pegylated interferon alfa-2a (PEG-IFN) and weight-based ribavirin (WBR) would improve hepatitis C virus (HCV) virologic responses in HCV treatment-naïve HIV-1/HCV genotype 1 coinfected persons. METHODS:Prospective, single-arm study in which subjects received ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/hct1406-274
更新日期:2013-11-01 00:00:00
abstract:BACKGROUND:A safe, effective, easy-to-dose antiretroviral therapy that minimizes hepatic complication risk is essential in optimizing HIV-HCV treatment. Nucleoside-sparing boosted protease inhibitor monotherapy may achieve this goal. METHODS:A prospective, open-label pilot simplification study of once-daily lopinavir/...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/hct1304-179
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:Nevirapine, a nonnucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the durable suppression of HIV with nevirapine when used along with other nucleosides in HIV-infected patients who are treated in clinical practice n...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1310/4nb4-1gx6-4xvk-pbgl
更新日期:2003-07-01 00:00:00
abstract:BACKGROUND:Immune response rates following influenza vaccination are often lower in HIV-infected individuals. Low vitamin D levels were correlated with weak immune response in cancer patients and are known to be lower in HIV-infected patients. METHODS:Diagnostic study to determine immune response against the H1N1v com...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1404-175
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND:Exercise training has been shown to be an effective strategy to balance oxidative stress status; however, this is underexplored in people living with HIV/AIDS (PLWHA). OBJECTIVE:To evaluate the effects of exercise training on oxidative stress in PLWHA receiving antiretroviral therapy. METHODS:Patients perf...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1080/15284336.2018.1481247
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND:The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. OBJECTIVE:This paper describes the challenges and specific strategies used to re...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1080/15284336.2018.1513711
更新日期:2018-10-01 00:00:00
abstract:PURPOSE:To characterize the steady-state pharmacokinetic combination of the nonpeptidic protease inhibitor tipranavir (TPV) with ritonavir (RTV) in 95 healthy adult volunteers, a phase 1, single-center, open-label, randomized, parallel-group trial was conducted. METHOD:Participants received 250-mg self-emulsifying dru...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1310/RRX7-49ME-27V7-MWWV
更新日期:2004-11-01 00:00:00
abstract:PURPOSE:To assess the virologic and immunologic response to a boosted double-protease inhibitor (PI) regimen of highly pretreated patients infected with HIV-1 and to examine the role of PI resistance and concentration of serum saquinavir. METHOD:In an open-label prospective study, lopinavir/ritonavir, saquinavir-sgc, ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/HAG3-8YA5-UDQC-36NX
更新日期:2005-03-01 00:00:00
abstract:BACKGROUND:Impaired allostimulatory function of dendritic cells in patients with AIDS has been reported previously. Granulocyte-macrophage colony-stimulating factor (GM-CSF) can restore the T-cell stimulatory function in transforming growth factor-beta 1 (TGF-beta 1)-inhibited murine accessory cells. We now report the ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/HP8B-NF27-VFWA-80YX
更新日期:2002-05-01 00:00:00
abstract:PURPOSE:We investigated the evolution of serum lipid levels in HIV-infected pregnant women and the potential effect of antiretroviral treatment during pregnancy using data from a national surveillance study. METHOD:Fasting lipid measurements collected during routine care in pregnancy were used, analyzing longitudinal ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0704-184
更新日期:2006-07-01 00:00:00
abstract:PURPOSE:The outdated rules of older HIV genotypic resistance algorithms can affect virologic responses. This study was designed to determine how often these incorrect resistance interpretations affect analyses of long-term clinical trials, antiretroviral (ARV) choices, and HIV disease progression rates. METHOD:Baselin...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0805-293
更新日期:2007-09-01 00:00:00
abstract:PURPOSE:We obtained peripheral blood monocytes from HIV-1-infected patients and differentiated them into macrophages in vitro to investigate the contribution of purified monocytes to plasma viremia in HIV-infected patients. METHOD:We compared the production of HIV-1 from purified monocytes isolated from patients who w...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/EF26-V3PC-AG5X-FCF4
更新日期:2002-11-01 00:00:00
abstract::Three HIV individuals with chronic hepatitis C presented with esophageal variceal bleeding. They had mild liver fibrosis and normal liver function tests. All had received didanosine for long periods. Noncirrhotic portal hypertension associated with didanosine may appear in HIV patients without any liver disease or add...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0906-440
更新日期:2008-11-01 00:00:00
abstract:BACKGROUND:Some individuals control HIV replication without antiretroviral (ARV) therapy. OBJECTIVE:To analyze viral suppression in young women in rural South Africa enrolled in a trial evaluating a behavioral intervention for HIV prevention. METHODS:Plasma samples were obtained from women ages 13-24 (81 infected at ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1080/15284336.2018.1531534
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:The lack of human resources for health is presently recognized as a major factor limiting scale-up of antiretroviral treatment (ART) programs in resourcelimited settings. The mobilization of public and private partners, the decentralization of care, and the training of non-HIV specialist nurses and general p...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0705-255
更新日期:2006-09-01 00:00:00
abstract:BACKGROUND:Simple antiretroviral drug combinations might provide a comparable benefit to standard triple regimens in patients with mild HIV disease, because poor adherence and toxicities often compromise the sustained benefit of the latest triple regimens, especially when protease inhibitors are used. Bad adherence is ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1310/FAJF-7A8G-QAR4-Q0X5
更新日期:2002-01-01 00:00:00
abstract:PURPOSE:Questionnaires assessing patient-reported outcomes in HIV are either too long or not HIV-specific. Our aim was to develop and validate a simplified HIV patient questionnaire. METHOD:607 HIV patients treated with a combination of antiretroviral (ARV) drugs were enrolled in an observational, longitudinal study. ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1004-215
更新日期:2009-07-01 00:00:00
abstract::This article reports noteworthy HIV/AIDS clinical trials presented at the XVth International AIDS Conference, Bangkok, July 2004, and also outlines goals of comprehensive prevention, care, treatment, and monitoring plans. The Bangkok conference theme was "Access for All." Outlined are goals of comprehensive prevention...
journal_title:HIV clinical trials
pub_type:
doi:10.1310/RM35-RE2A-J9L2-8J47
更新日期:2005-01-01 00:00:00
abstract::Naturally occurring polymorphisms at positions involved in resistance to antiretroviral agents are frequently seen in HIV-1 non-B subtypes. Although they do not seem to affect significantly the susceptibility to antiretroviral drugs in vitro, they may facilitate the selection of different pathways and/or a more rapid ...
journal_title:HIV clinical trials
pub_type: 杂志文章,评审
doi:10.1310/7bwp-0x7f-nxna-qrnp
更新日期:2002-09-01 00:00:00
abstract:BACKGROUND:Raltegravir (RAL) constitutes the first available integrase strand transfer inhibitor (INSTI) available in clinical practice. Three independent pathways have been described to confer resistance to RAL. Secondary mutations with little effect on INSTI susceptibility and additional substitutions with an uncerta...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1310/hct1401-10
更新日期:2013-01-01 00:00:00
abstract:OBJECTIVES:ARTEMIS demonstrated significantly greater efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100 mg versus lopinavir/ritonavir 800/200 mg (total daily dose) in treatment-naïve, HIV-1-infected patients at week 96. The influence of baseline characteristics on efficacy and safety was analyzed in DRV/r pati...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/hct1206-313
更新日期:2011-11-01 00:00:00
abstract:METHOD:Analysis of virological, immunological, and clinical data over 24 weeks of treatment of drug-experienced patients administered didanosine (ddI) and tenofovir (TDF) plus either PI or NNRTI (17 patients) compared to 14 patients on ddI plus lamivudine and to 19 patients on ddI plus stavudine. RESULTS:Patients trea...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/0B0R-J1LP-KQPF-43HB
更新日期:2006-01-01 00:00:00
abstract:PURPOSE:The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients. METHOD:We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1310/brbv-3941-h1pp-ndry
更新日期:2003-03-01 00:00:00
abstract:PURPOSE:Treatment options for HIV-associated lipodystrophy syndrome (HALS) remain limited. The objective of this randomized open-label study was to compare three emerging therapies, rosiglitazone, pravastatin, and growth hormone alone and together, in men and women with HALS. METHOD:Sixty-four subjects received daily ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1310/hct0904-254
更新日期:2008-07-01 00:00:00