Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events
IDEAL
1 other identifier
interventional
61
1 country
17
Brief Summary
The purpose of this study is to compare the early versus deferred initiation of antiretroviral combination therapy consisting of tenofovir, emtricitabine and atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2011
Longer than P75 for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedNovember 28, 2016
September 1, 2016
3.8 years
August 10, 2011
November 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization
Clinical Progression (death, all new or relapsing OI, other Grade 4 clinical endpoint) within 24 weeks. For abnormalities not found in the Toxicity Tables, a Grade 4 event will be defined as potentially life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Patients who drop out of study observation before end of week 12 are counted as clinical progression.
24 weeks
Secondary Outcomes (6)
Hospitalization days after completion of initial OI treatment between both groups
24 weeks
incidence of immune reconstitution inflammatory syndrome
24 weeks
virological outcome
24 weeks
efficacy and toxicity of the antiretroviral therapy
24 weeks
quality of life
24 weeks
- +1 more secondary outcomes
Study Arms (2)
Immediate arm
ACTIVE COMPARATORImmediate arm: ART should be initiated as soon as possible but no later than 3 days after initiation of OI treatment.
Deferred arm
ACTIVE COMPARATORDeferred arm: ART should be initiated after the completion of OI treatment which is achieved at the earliest at day 21 for PCP and at day 28 for TE. ART should be initiated no later than 6 weeks after initiation of OI treatment.
Interventions
Within 24 hours after sending the screening form, the site investigator will receive a randomization sheet with the decision when to start ART ("immediate" or "deferred"). The day of receiving the randomization sheet will be defined as baseline visit.
Eligibility Criteria
You may qualify if:
- Adult (at least 18 years) HIV-1 infected subjects
- Antiretroviral naïve HIV-1-infected patients who have developed an acute AIDS defining event, namely PCP or Toxoplasmosis (women receiving prior MTCT prophylaxis may be enrolled)
- Patients who are able to take or to receive antiretroviral treatment and who are able to give written consent
You may not qualify if:
- Renal failure or CrCl \< 60 mL/min
- Patients who are not able to initiate ART or with current contraindications against atazanavir/ritonavir
- Other AIDS-defining events than PCP or TE (exceptions see below)
- Pregnancy/Women of childbearing potential who want to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
ICH Study Center GmbH & CO. KG
Hamburg, Hamburg, 20146, Germany
Vivantes Auguste-Viktoria-Klinikum
Berlin, State of Berlin, 12157, Germany
Charitè Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, State of Berlin, 13353, Germany
Universitätsklinikum Bonn, Innere Medizin I, Immunologische Ambulanz/Studienzentrale
Bonn, 53127, Germany
Universitätsklinik Köln, Klinik I für Innere Medizin
Cologne, 50937, Germany
Medizinische Klinik Nord
Dortmund, 44137, Germany
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
Düsseldorf, 40225, Germany
Universitätshauptklinik Essen
Essen, 45122, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik II / Infektiologie
Frankfurt am Main, 60590, Germany
Universitätsklinikum Freiburg, Centrum Chronische Immundefizienz (CCI)
Freiburg im Breisgau, 79106, Germany
ifi Hamburg an der Asklepios Klinik St. Georg
Hamburg, 20099, Germany
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit,
Hamburg, 20249, Germany
Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie
Hanover, 30625, Germany
Universitätsklinikum Kiel, II. Medizinisch Klinik, UKSH, Campus Kiel
Kiel, 24116, Germany
Universitätsklinikum München, Infektionsabteilung, Med. Poliklinik, Klinikum der Universität München, Campus Innenstadt
München, 80336, Germany
Universitätsklinkum Ulm, Comprehensive Infectious Diseases Center (CIDC) Ulm, Sektion Infektiologie und Klinische Immunologie, Zentrum für Innere Medizin, Innere Medizin III
Ulm, 89081, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Schmiedel, MD
Infectious Diseases Unit, University Medical Center Hamburg-Eppendorf
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 16, 2011
Study Start
August 1, 2011
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
November 28, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share