scholarly journals Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: study protocol of a multi-center prospective randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiao-Qing He ◽  
Yin-Qiu Huang ◽  
Yan-Ming Zeng ◽  
Yuan-Yuan Qin ◽  
Sheng-Quan Tang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Clinical Evidence ◽  
Controlled Trial ◽  
Cytomegalovirus Retinitis ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Art Initiation ◽  
Prospective Randomized Controlled Trial

Abstract Background Cytomegalovirus retinitis (CMVR) is an important opportunistic infection (OI) occurring mainly in patients with acquired immunodeficiency syndrome (AIDS) and has the potential to cause severe visual impairment and blindness among AIDS patients. Subsequent to the adoption and implementation of widespread antiretroviral therapy (ART), the prognosis of AIDS-associated CMVR has been substantially improved. Nevertheless, the equivocal clinical evidence as regards the optimal timing for ART initiation in patients with an established CMVR diagnosis is required. We therefore designed the present study in order to investigate the optimal timing for ART initiation in AIDS/CMVR patients. Methods This will be a prospective, randomized controlled trial to be performed at 17 hospitals in mainland China. A total of 300 participants with CMVR will be randomly assigned to an early ART initiation group (ART initiation within 2 weeks after anti-CMV therapy), or a deferred ART initiation group (initiation of ART more than 2 weeks after anti-CMV therapy) at a 1:1 ratio. All participants will receive 48 weeks of follow-up after anti-CMV therapy initiation. Our primary outcome will be the incidence of visual loss (to a visual acuity worse than 20/40 or 20/200) in the two groups during the 48-week follow-up period. Secondary outcomes will include changes in HIV virological suppression and serum CD4+ T-cell counts, the incidence of mortality, retinitis progression (movement of the peripheral border of a CMV lesion ≥ ½ disc diameter, or occurrence of a new CMV lesion), retinal detachment, immune recovery uveitis (IRU), and other OIs and adverse events between the two study groups during the 48 weeks of follow-up. Discussion The study aims to investigate the optimal timing for ART initiation in AIDS/CMVR patients. We hope to be able to extract robust clinical evidence for use in optimal AIDS/CMVR management should our trial be successful. Trial registration This research was registered as one of the twelve clinical trials under the name of a general project “A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections”, ChiCTR1900021195. Registered on 1 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35362.

scholarly journals Timing of Antiretroviral Therapy for HIV-Infected Patients with Cytomegalovirus Retinitis: Study Protocol of a Multi-Center Prospective Randomized Controlled Trial

2020 ◽  
Author(s):  
Xiao-Qing He ◽  
Yin-Qiu Huang ◽  
Yan-Ming Zeng ◽  
Yuan-Yuan Qin ◽  
Sheng-Quan Tang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Controlled Trial ◽  
Cytomegalovirus Retinitis ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Art Initiation ◽  
Cell Counts ◽  
Prospective Randomized Controlled Trial

Abstract Background: Cytomegalovirus retinitis (CMVR) is an important opportunistic infection (OI) occurring mainly in patients with acquired immunodeficiency syndrome (AIDS), and has the potential to cause severe visual impairment and blindness among AIDS patients. Subsequent to the adoption and implementation of widespread antiretroviral therapy (ART), the prognosis of AIDS-associated CMVR has been substantially improved. Nevertheless, there remains some controversy with regards to the optimal timing for ART initiation in patients with an established CMVR diagnosis. We therefore designed the present study in order to investigate the optimal timing for ART initiation in AIDS/CMVR patients.Methods: This will be a prospective, randomized controlled trial to be performed at 17 hospitals in mainland China. A total of 300 participants with CMVR will be randomly assigned to an early ART initiation group (ART initiation within 2 weeks after anti-CMV therapy), or a deferred ART initiation group (initiation of ART more than 2 weeks after anti-CMV therapy) at a 1:1 ratio. All participants will receive 48-weeks of follow-up after anti-CMV therapy initiation. Our primary outcome will be the incidence of visual loss (to a visual acuity worse than 20/40 or 20/200) in the two groups during the 48-week follow-up period. Secondary outcomes will include changes in HIV virological suppression and serum CD4+ T-cell counts, the incidence of mortality, retinitis progression (movement of the peripheral border of a CMV lesion ≥ ½ disc diameter, or occurrence of a new CMV lesion), retinal detachment, immune recovery uveitis (IRU), and other OIs and adverse events between the two study groups during the 48 weeks of follow-up. Discussion:The study aims to investigate the optimal timing for ART initiation in AIDS/CMVR patients. We hope to be able to extract robust clinical evidence for use in optimal AIDS/CMVR management should our trial be successful.Trial registration: This research was registered as one of the twelve clinical trials under the name of a general project “A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections”, ChiCTR1900021195. Registered 1 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35362.

scholarly journals Timing of antiretroviral therapy for HIV-infected patients with moderate-to-severe Pneumocystis pneumonia: study protocol for a multi-center prospective randomized controlled trial

2020 ◽  
Author(s):  
Yuanyuan Qin ◽  
Yanqiu Lu ◽  
Yihong Zhou ◽  
Vijay Harypursat ◽  
Feng Sun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Opportunistic Infections ◽  
Controlled Trial ◽  
Pneumocystis Pneumonia ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Art Initiation ◽  
Prospective Randomized Controlled Trial ◽  
Registration Number

Abstract Background: Pneumocystis pneumonia (PCP) is a common AIDS-related opportunistic infection. Recent reports estimate that more than 400,000 HIV patients develop PCP each year globally. However, the timing of antiretroviral therapy (ART) initiation for HIV infected patients with PCP is still controversial, and the benefits and risks of early initiation of ART are not completely clear. We thus designed this study in order to determine the optimal timing for ART initiation for HIV-positive patients with moderate to severe PCP.Methods: This study will be an open-labelled, multi-center, prospective, randomized controlled trial. A total of 200 subjects will be randomized to an early ART initiation group (≤14 days after PCP diagnosis), and a deferred ART initiation group (>14 days after PCP diagnosis) at a 1:1 ratio. All subjects will be followed up for 48 weeks after starting ART. The primary outcome is incidence of disease progression (including new opportunistic infections and all-cause mortality) at week 48. The secondary endpoints are the changes in CD4 counts from baseline at week 12, week 24 and week 48, the degree of virological suppression (HIV-RNA<50 copies/mL) at week 24 and week 48, the rate of development of PCP-associated immune reconstitution inflammatory syndrome (IRIS), and adverse events(AEs) at each visit.Discussion: We hope that the results of this study will reveal the optimal timing for initiation of ART in HIV-infected patients with moderate to severe PCP.Trial registration: This trial was registered as one of the twelve trials under the name of a general project at chictr.org.cn on February 1, 2019, and the registration number of the general project is ChiCTR1900021195.

scholarly journals Prospective, Randomized, Controlled Trial Using Best-Selling Smoking-Cessation Book

2017 ◽  
Vol 96 (7) ◽  
pp. 258-263
Author(s):  
James P. Foshee ◽  
Anita Oh ◽  
Adam Luginbuhl ◽  
Joseph Curry ◽  
William Keane ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Smoking Cessation Counseling ◽  
Randomized Controlled ◽  
Quit Smoking ◽  
Stop Smoking ◽  
Prospective Randomized Controlled Trial

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information

2011 ◽  
Vol 45 (11) ◽  
pp. 1378-1383 ◽  
Author(s):  
Kyle Wilby ◽  
Carlo A Marra ◽  
Jack H da Silva ◽  
Maja Grubisic ◽  
Stephanie Harvard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Fisher Exact Test ◽  
Intended Meaning ◽  
Randomized Controlled ◽  
Medication Information

Background:: Antiretroviral therapy for the management of HIV typically requires the chronic use of 3 or more medications. As such, patients with HIV are required to manage complex dosing schedules and are at risk of multiple potential adverse effects. The use of pictograms on medication vials as a means of improving patients' understanding of medication information has been shown to positively influence understanding and adherence compared to those using text atone. Objective: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can interpret the intended meaning of pictograms that they had not seen previously. Methods: A randomized, controlled trial was conducted in HIV-positive patients aged 19 years or older who were receiving a new prescription for an antiretroviral medication from the ambulatory pharmacy at St. Paul's Hospital in Vancouver, British Columbia, Canada. Participants were randomized to receive either pictogram-enhanced medication information or standard counseling. At the first follow-up visit, each patient's recall of the medication information was evaluated, and differences between groups were compared. Results: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly equal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 in the control arm completed the study. The majority (88%) of the targeted pieces of information in the intervention group were correctly identified at follow-up, compared to only 2% in the control group (Fisher exact test; p < 0.0001). Conclusions: Pictograms improve the recall of targeted medication information among patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal explanation of each pictogram prior to use.

Sign in / Sign up

Export Citation Format

Share Document