Immediate versus deferred antiretroviral therapy in HIV-infected patients presenting with acute AIDS-defining events (toxoplasmosis, Pneumocystis jirovecii-pneumonia): a prospective, randomized, open-label multicenter study (IDEAL-study)

  • Background: To evaluate clinical outcomes after either immediate or deferred initiation of antiretroviral therapy in HIV-1-infected patients, presenting late with pneumocystis pneumonia (PCP) or toxoplasma encephalitis (TE). Methods: Phase IV, multicenter, prospective, randomized open-label clinical trial. Patients were randomized into an immediate therapy arm (starting antiretroviral therapy (ART) within 7 days after initiation of OI treatment) versus a deferred arm (starting ART after completing the OI-therapy). All patients were followed for 24 weeks. The rates of clinical progression (death, new or relapsing opportunistic infections (OI) and other grade 4 clinical endpoints) were compared, using a combined primary endpoint. Secondary endpoints were hospitalization rates after completion of OI treatment, incidence of immune reconstitution inflammatory syndrome (IRIS), virologic and immunological outcome, adherence to proteinase-inhibitor based antiretroviral therapy (ART) protocol and quality of life. Results: 61 patients (11 patients suffering TE, 50 with PCP) were enrolled. No differences between the two therapy groups in all examined primary and secondary endpoints could be identified: immunological and virologic outcome was similar in both groups, there was no significant difference in the incidence of IRIS (11 and 10 cases), furthermore 9 events (combined endpoint of death, new/relapsing OI and grade 4 events) occurred in each group. Conclusions: In summary, this study supports the notion that immediate initiation of ART with a ritonavir-boosted proteinase-inhibitor and two nucleoside reverse transcriptase inhibitors is safe and has no negative effects on incidence of disease progression or IRIS, nor on immunological and virologic outcomes or on quality of life.

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Author:Guido Schäfer, Christian Hoffmann, Keikawus Arasteh, Dirk Schürmann, Christoph Stephan, Björn Jensen, Matthias Stoll, Johannes Bogner, Gerd Fätkenheuer, Jürgen Rockstroh, Hartwig Klinker, Georg Härter, Albrecht Stöhr, Olaf Degen, Eric Freiwald, Anja Hüfner, Sabine Jordan, Julian Constantin Raimar Schulze zur Wiesch, Marylyn M. Addo, Ansgar W. Lohse, Jan Van Lunzen, Stefan Schmiedel
Pubmed Id:
Parent Title (English):AIDS research and therapy
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Year of Completion:2019
Date of first Publication:2019/11/15
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Contributing Corporation:IDEAL study group
Release Date:2020/04/22
Tag:Cerebral toxoplasmosis HIV; Diagnosis; Late presentation; Opportunistic infections; PCP; Pneumocystis jirovecii; Treatment
Issue:1, Art. 34
Page Number:8
First Page:1
Last Page:8
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 4.0