TY  - JOUR
A1  - Schäfer, Guido
A1  - Hoffmann, Christian
A1  - Arasteh, Keikawus
A1  - Schürmann, Dirk
A1  - Stephan, Christoph
A1  - Jensen, Björn
A1  - Stoll, Matthias
A1  - Bogner, Johannes
A1  - Fätkenheuer, Gerd
A1  - Rockstroh, Jürgen
A1  - Klinker, Hartwig
A1  - Härter, Georg
A1  - Stöhr, Albrecht
A1  - Degen, Olaf
A1  - Freiwald, Eric
A1  - Hüfner, Anja
A1  - Jordan, Sabine
A1  - Schulze zur Wiesch, Julian Constantin Raimar
A1  - Addo, Marylyn M.
A1  - Lohse, Ansgar W.
A1  - Van Lunzen, Jan
A1  - Schmiedel, Stefan
T1  - 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)
T2  - AIDS research and therapy
N2  - 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.
KW  - Late presentation
KW  - Opportunistic infections
KW  - Pneumocystis jirovecii
KW  - PCP
KW  - Cerebral toxoplasmosis HIV
KW  - Diagnosis
KW  - Treatment
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/53346
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-533468
SN  - 1742-6405
N1  - Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), 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 (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
VL  - 16
IS  - 1, Art. 34
SP  - 1
EP  - 8
PB  - BioMed Central
CY  - London
ER  -