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Clinical Trial
. 2019 Nov 15;16(1):34.
doi: 10.1186/s12981-019-0250-2.

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)

Guido Schäfer  1   2 , Christian Hoffmann  3 , Keikawus Arasteh  4 , Dirk Schürmann  5 , Christoph Stephan  6 , Björn Jensen  7 , Matthias Stoll  8 , Johannes R Bogner  9 , Gerd Faetkenheuer  10 , Jürgen Rockstroh  11 , Hartwig Klinker  12 , Georg Härter  13 , Albrecht Stöhr  14 , Olaf Degen  15 , Eric Freiwald  16 , Anja Hüfner  15 , Sabine Jordan  15   17 , Julian Schulze Zur Wiesch  15   17 , Marylyn Addo  17 , Ansgar W Lohse  17 , Jan van Lunzen  18 , Stefan Schmiedel  15   17 ; IDEAL study group
Affiliations
Clinical Trial

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)

Guido Schäfer et al. AIDS Res Ther. .

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.

Keywords: Cerebral toxoplasmosis HIV; Diagnosis; Late presentation; Opportunistic infections; PCP; Pneumocystis jirovecii; Treatment.

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Conflict of interest statement

Johannes R. Bogner received honorary for advisory boards and lecturing from AbbVie, ViiV, MSD, Gilead, Janssen, BMS, Hexal. Christian Hoffmann has received honoraria for lecturing, advisory boards and travelling grants and research grants from AbbVie, Bristol Myers-Squibb, Boehringer-Ingelheim, Gilead Sciences, HEXAL, Hormosan, Janssen-Cilag, MSD, Teratech and ViiV Healthcare. Gerd Faetkenheuer received lecture fees, honorary for advisory boards, and travel and research grants: Bristol Myers Squibb, Gilead, Merck Sharp & Dohme. Jan van Lunzen has received honoraria for lecturing, advisory boards and travelling grants from AbbVie, Bristol Myers-Squibb, Boehringer-Ingelheim, Gilead Sciences, HEXAL, Janssen-Cilag, MSD, Teratech and ViiV Healthcare. Christoph Stephan received financial support, related to scientific projects by MSD, BMS, AbbVie and received honorary for lectures or scientific advisory boards from: Abbott, BMS, ViiV, Gilead, Janssen, Roche. Juergen Rockstroh has received honoraria for consulting or speaking at educational events from Abbvie, BMS, Gilead, Merck, Janssen and ViiV. Olaf Degen received honoraria for lecturing, advisory boards and travelling grants from ViiV, GSK, Gilead, BMS, Janssen-Cilag. Matthias Stoll received honoraria as advisor, lecturer or funding of studies by Abbott, Abbvie, Boehringer-Ingelheim, Bristol-Myers-Squibb, Gilead, Glaxo-Smith-Kline, Hexal, Hormosan, Janssen-Cilag, Merck, Sharp & Dohme, Novartis, Pfizer, Roche, Tibotec, ViiV, Viro-Pharmaceuticals. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study subject enrollment and discontinuations
See this image and copyright information in PMC

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