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

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.