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

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 |

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.
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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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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.
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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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- 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.
- Hospitalization days after completion of initial OI treatment between both groups [ Time Frame: 24 weeks ]Hospitalization days after completion of OI treatment
- 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.
- virological outcome [ Time Frame: 24 weeks ]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 ]Proportion of patients with changes in ARV regimen for lack of efficacy or of toxicity
- quality of life [ Time Frame: 24 weeks ]Quality of life (QOL), including overall self-reported QOL at Week 24
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Stefan Schmiedel, MD | Infectious Diseases Unit, University Medical Center Hamburg-Eppendorf |
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 |