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Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01417949
First received: August 10, 2011
Last updated: November 25, 2016
Last verified: September 2016
  Purpose
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).

Condition Intervention Phase
HIV-Infection
Other: Time of starting antiretroviral therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL-Study)

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Hospitalization days after completion of initial OI treatment between both groups [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Hospitalization days after completion of OI treatment

  • incidence of immune reconstitution inflammatory syndrome [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Incidence of immune reconstitution inflammatory syndrome (IRIS) as judged by the site investigator (for definitions see below) compared in the two groups during the first 24 weeks.

  • virological outcome [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Virological outcome at week 24 (proportion of patients achieving HIV RNA < 400 (<50 copies/mL).

  • efficacy and toxicity of the antiretroviral therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Proportion of patients with changes in ARV regimen for lack of efficacy or of toxicity

  • quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Quality of life (QOL), including overall self-reported QOL at Week 24

  • immunological outcome [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    For evaluation of immunological outcome, CD4 T-cell counts at week 24 (absolute, relative, CD4/CD8 ratio) and the change in CD4 T-cell counts from baseline will be assessed.


Enrollment: 61
Study Start Date: August 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate arm
Immediate arm: ART should be initiated as soon as possible but no later than 3 days after initiation of OI treatment.
Other: Time of starting antiretroviral therapy
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.
Active Comparator: Deferred arm
Deferred 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.
Other: Time of starting antiretroviral therapy
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417949

Locations
Germany
Vivantes Auguste-Viktoria-Klinikum
Berlin, Germany, 12157
Charitè Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany, 13353
Universitätsklinikum Bonn, Innere Medizin I, Immunologische Ambulanz/Studienzentrale
Bonn, Germany, 53127
Medizinische Klinik Nord
Dortmund, Germany, 44137
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
Düsseldorf, Germany, 40225
Universitätshauptklinik Essen
Essen, Germany, 45122
Universitätsklinikum Frankfurt, Medizinische Klinik II / Infektiologie
Frankfurt am Main, Germany, 60590
Universitätsklinikum Freiburg, Centrum Chronische Immundefizienz (CCI)
Freiburg, Germany, 79106
ifi Hamburg an der Asklepios Klinik St. Georg
Hamburg, Germany, 20099
ICH Study Center GmbH & CO. KG
Hamburg, Germany, 20146
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit,
Hamburg, Germany, 20249
Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie
Hannover, Germany, 30625
Universitätsklinikum Kiel, II. Medizinisch Klinik, UKSH, Campus Kiel
Kiel, Germany, 24116
Universitätsklinik Köln, Klinik I für Innere Medizin
Köln, Germany, 50937
Universitätsklinikum München, Infektionsabteilung, Med. Poliklinik, Klinikum der Universität München, Campus Innenstadt
München, Germany, 80336
Universitätsklinkum Ulm, Comprehensive Infectious Diseases Center (CIDC) Ulm, Sektion Infektiologie und Klinische Immunologie, Zentrum für Innere Medizin, Innere Medizin III
Ulm, Germany, 89081
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Stefan Schmiedel, MD Infectious Diseases Unit, University Medical Center Hamburg-Eppendorf
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01417949     History of Changes
Other Study ID Numbers: EudraCT Nr. 2010-022413-26 
Study First Received: August 10, 2011
Last Updated: November 25, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on December 06, 2016