PMID- 31729999
OWN - NLM
STAT- MEDLINE
DCOM- 20200505
LR  - 20231019
IS  - 1742-6405 (Electronic)
IS  - 1742-6405 (Linking)
VI  - 16
IP  - 1
DP  - 2019 Nov 15
TI  - 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).
PG  - 34
LID - 10.1186/s12981-019-0250-2 [doi]
LID - 34
AB  - 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.
FAU - Schafer, Guido
AU  - Schafer G
AUID- ORCID: 0000-0002-0983-4234
AD  - Infectious Diseases Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, 
      Germany. g.schaefer@uke.de.
AD  - 1st Medical Department, Section Infectious Diseases & Tropical Medicine, 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany. g.schaefer@uke.de.
FAU - Hoffmann, Christian
AU  - Hoffmann C
AD  - ICH Study Center GmbH & Co KG, Hamburg, Germany.
FAU - Arasteh, Keikawus
AU  - Arasteh K
AD  - Department for Infectious Diseases, Vivantes Auguste-Viktoria-Klinikum, Berlin, 
      Germany.
FAU - Schurmann, Dirk
AU  - Schurmann D
AD  - Department for Pneumology and Infectious Diseases, Charite Universitatsmedizin, 
      Berlin, Germany.
FAU - Stephan, Christoph
AU  - Stephan C
AD  - 2nd Medical Department, Section Infectious Diseases, University Medical Center, 
      Frankfurt am Main, Germany.
FAU - Jensen, Bjorn
AU  - Jensen B
AD  - Department for Gastroenterology, Hepatology, Infectious Diseases, 
      Universitatsklinikum Dusseldorf, Dusseldorf, Germany.
FAU - Stoll, Matthias
AU  - Stoll M
AD  - Department for Immunology and Rheumatology, Medizinische Hochschule Hannover, 
      Hannover, Germany.
FAU - Bogner, Johannes R
AU  - Bogner JR
AD  - Department for Infectious Diseases, Mediznische Klinik und Poliklinik IV der 
      Universitat Munchen, Munich, Germany.
FAU - Faetkenheuer, Gerd
AU  - Faetkenheuer G
AD  - 1st Medical Department, Section Infectious Diseases, Universitatsklinikum Koln, 
      Cologne, Germany.
FAU - Rockstroh, Jurgen
AU  - Rockstroh J
AD  - Medical Department, Section Infectious Diseases, Universitatsklinikum Bonn, Bonn, 
      Germany.
FAU - Klinker, Hartwig
AU  - Klinker H
AD  - Department for Infectious Diseases, Julius Maximilians University, Wurzburg, 
      Germany.
FAU - Harter, Georg
AU  - Harter G
AD  - Department for Infectious Diseases, University Hospital, Ulm, Germany.
FAU - Stohr, Albrecht
AU  - Stohr A
AD  - ifi-Institute for Interdisciplinary Medicine, Hamburg, Germany.
FAU - Degen, Olaf
AU  - Degen O
AD  - Infectious Diseases Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, 
      Germany.
FAU - Freiwald, Eric
AU  - Freiwald E
AD  - Institute for Medical Biometry and Epidemiology, University Medical Center 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - Hufner, Anja
AU  - Hufner A
AD  - Infectious Diseases Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, 
      Germany.
FAU - Jordan, Sabine
AU  - Jordan S
AD  - Infectious Diseases Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, 
      Germany.
AD  - 1st Medical Department, Section Infectious Diseases & Tropical Medicine, 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
FAU - Schulze Zur Wiesch, Julian
AU  - Schulze Zur Wiesch J
AD  - Infectious Diseases Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, 
      Germany.
AD  - 1st Medical Department, Section Infectious Diseases & Tropical Medicine, 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
FAU - Addo, Marylyn
AU  - Addo M
AD  - 1st Medical Department, Section Infectious Diseases & Tropical Medicine, 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
FAU - Lohse, Ansgar W
AU  - Lohse AW
AD  - 1st Medical Department, Section Infectious Diseases & Tropical Medicine, 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
FAU - van Lunzen, Jan
AU  - van Lunzen J
AD  - ViiV Healthcare, Research Triangle, USA.
FAU - Schmiedel, Stefan
AU  - Schmiedel S
AD  - Infectious Diseases Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, 
      Germany.
AD  - 1st Medical Department, Section Infectious Diseases & Tropical Medicine, 
      University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
CN  - IDEAL study group
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191115
PL  - England
TA  - AIDS Res Ther
JT  - AIDS research and therapy
JID - 101237921
RN  - 0 (Anti-Retroviral Agents)
SB  - IM
MH  - AIDS-Related Opportunistic Infections
MH  - Acquired Immunodeficiency Syndrome/complications/*drug therapy
MH  - Adult
MH  - Anti-Retroviral Agents/*therapeutic use
MH  - *Antiretroviral Therapy, Highly Active
MH  - Disease Progression
MH  - Drug Administration Schedule
MH  - Female
MH  - Germany
MH  - HIV Infections/complications/*drug therapy
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Pneumonia, Pneumocystis/*virology
MH  - Prospective Studies
MH  - Quality of Life
MH  - Toxoplasmosis/*virology
PMC - PMC6857475
OTO - NOTNLM
OT  - Cerebral toxoplasmosis HIV
OT  - Diagnosis
OT  - Late presentation
OT  - Opportunistic infections
OT  - PCP
OT  - Pneumocystis jirovecii
OT  - Treatment
COIS- 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.
EDAT- 2019/11/16 06:00
MHDA- 2020/05/06 06:00
PMCR- 2019/11/15
CRDT- 2019/11/16 06:00
PHST- 2019/08/13 00:00 [received]
PHST- 2019/10/26 00:00 [accepted]
PHST- 2019/11/16 06:00 [entrez]
PHST- 2019/11/16 06:00 [pubmed]
PHST- 2020/05/06 06:00 [medline]
PHST- 2019/11/15 00:00 [pmc-release]
AID - 10.1186/s12981-019-0250-2 [pii]
AID - 250 [pii]
AID - 10.1186/s12981-019-0250-2 [doi]
PST - epublish
SO  - AIDS Res Ther. 2019 Nov 15;16(1):34. doi: 10.1186/s12981-019-0250-2.