Universität zu Köln

Schaefer, Guido, Hoffmann, Christian, Arasteh, Keikawus, Schuermann, Dirk, Stephan, Christoph, Jensen, Bjoern, Stoll, Matthias, Bogner, Johannes R., Faetkenheuer, Gerd, Rockstroh, Juergen, Klinker, Hartwig, Haerter, Georg, Stoehr, Albrecht, Degen, Olaf, Freiwald, Eric, Huefner, Anja, Jordan, Sabine, Zur Wiesch, Julian Schulze, Addo, Marylyn, Lohse, Ansgar W., van Lunzen, Jan and Schmiedel, Stefan (2019). 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). Aids Res. Ther., 16 (1). LONDON: BMC. ISSN 1742-6405

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schaefer, Guido UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoffmann, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Arasteh, Keikawus UNSPECIFIED UNSPECIFIED UNSPECIFIED Schuermann, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Stephan, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Jensen, Bjoern UNSPECIFIED UNSPECIFIED UNSPECIFIED Stoll, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Bogner, Johannes R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Rockstroh, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Klinker, Hartwig UNSPECIFIED UNSPECIFIED UNSPECIFIED Haerter, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Stoehr, Albrecht UNSPECIFIED UNSPECIFIED UNSPECIFIED Degen, Olaf UNSPECIFIED UNSPECIFIED UNSPECIFIED Freiwald, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Huefner, Anja UNSPECIFIED UNSPECIFIED UNSPECIFIED Jordan, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Zur Wiesch, Julian Schulze UNSPECIFIED UNSPECIFIED UNSPECIFIED Addo, Marylyn UNSPECIFIED UNSPECIFIED UNSPECIFIED Lohse, Ansgar W. UNSPECIFIED UNSPECIFIED UNSPECIFIED van Lunzen, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmiedel, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-127526
DOI:	10.1186/s12981-019-0250-2
Journal or Publication Title:	Aids Res. Ther.
Volume:	16
Number:	1
Date:	2019
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1742-6405
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language LATE DIAGNOSIS; INITIATION; START; CONSEQUENCES; INDIVIDUALS; COMBINATION; EFFICACY; EARLIER; SAFETY; TIME Multiple languages Infectious Diseases Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/12752