Superiority of Directly Administered Antiretroviral Therapy over Self-Administered Therapy among HIV-Infected Drug Users: A 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.

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

Trials ◽

10.1186/s13063-021-05159-y ◽

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.

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

10.21203/rs.3.rs-19306/v1 ◽

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.

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