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

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ClinicalTrials.gov Identifier: NCT01417949
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV-Infection Other: Time of starting antiretroviral therapy Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL-Study)
Study Start Date : August 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization [ Time Frame: 24 weeks ]
    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 :
  1. Hospitalization days after completion of initial OI treatment between both groups [ Time Frame: 24 weeks ]
    Hospitalization days after completion of OI treatment

  2. incidence of immune reconstitution inflammatory syndrome [ Time Frame: 24 weeks ]
    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.

  3. virological outcome [ Time Frame: 24 weeks ]
    Virological outcome at week 24 (proportion of patients achieving HIV RNA < 400 (<50 copies/mL).

  4. efficacy and toxicity of the antiretroviral therapy [ Time Frame: 24 weeks ]
    Proportion of patients with changes in ARV regimen for lack of efficacy or of toxicity

  5. quality of life [ Time Frame: 24 weeks ]
    Quality of life (QOL), including overall self-reported QOL at Week 24

  6. immunological outcome [ Time Frame: 24 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01417949     History of Changes
Other Study ID Numbers: EudraCT Nr. 2010-022413-26
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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