Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL)
This study is not yet open for participant recruitment.
Verified August 2011 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01417949
First received: August 10, 2011
Last updated: August 15, 2011
Last verified: August 2011
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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.
| Estimated Enrollment: | 210 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | August 2013 (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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417949
Contacts
| Contact: Jan van Lunzen, Prof. Dr. | +49 40 7410 52831 | v.lunzen@uke.uni-hamburg.de |
Locations
| Germany | |
| Universitätsklinikum Bonn, Innere Medizin I, Immunologische Ambulanz/Studienzentrale | Not yet recruiting |
| Bonn, Germany, 53127 | |
| Principal Investigator: Jürgen Rockstroh, MD, PhD | |
| Medizinische Klinik Nord | Not yet recruiting |
| Dortmund, Germany, 44137 | |
| Principal Investigator: Bernhard Schaaf, MD, PhD | |
| Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie | Not yet recruiting |
| Düsseldorf, Germany, 40225 | |
| Principal Investigator: Stefan Reuter, MD, PhD | |
| Universitätshauptklinik Essen | Not yet recruiting |
| Essen, Germany, 45122 | |
| Principal Investigator: Guido Gerken, MD, PhD | |
| Universitätsklinikum Frankfurt, Medizinische Klinik II / Infektiologie | Not yet recruiting |
| Frankfurt am Main, Germany, 60590 | |
| Principal Investigator: Christoph Stephan, MD, PhD | |
| Universitätsklinikum Freiburg, Centrum Chronische Immundefizienz (CCI) | Not yet recruiting |
| Freiburg, Germany, 79106 | |
| Principal Investigator: Winfried Kern, MD, PhD | |
| ifi Hamburg an der Asklepios Klinik St. Georg | Not yet recruiting |
| Hamburg, Germany, 20099 | |
| Principal Investigator: Albrecht Stoehr, MD, PhD | |
| ICH Study Center GmbH & CO. KG | Not yet recruiting |
| Hamburg, Germany, 20146 | |
| Principal Investigator: Christian Hoffmann, MD, PhD | |
| University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit, | Not yet recruiting |
| Hamburg, Germany, 20249 | |
| Principal Investigator: Jan van Lunzen, MD,PhD | |
| Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie | Not yet recruiting |
| Hannover, Germany, 30625 | |
| Principal Investigator: Matthias Stoll, MD, PhD | |
| Universitätsklinikum Kiel, II. Medizinisch Klinik, UKSH, Campus Kiel | Not yet recruiting |
| Kiel, Germany, 24116 | |
| Principal Investigator: Heinz A Horst, MD, PhD | |
| Universitätsklinik Köln, Klinik I für Innere Medizin | Not yet recruiting |
| Köln, Germany, 50937 | |
| Principal Investigator: Gerd Fätkenheuer, MD, PhD | |
| Universitätsklinikum München, Infektionsabteilung, Med. Poliklinik, Klinikum der Universität München, Campus Innenstadt | Not yet recruiting |
| München, Germany, 80336 | |
| Principal Investigator: Johannes Bogner, MD, PhD | |
| Universitätsklinkum Ulm, Comprehensive Infectious Diseases Center (CIDC) Ulm, Sektion Infektiologie und Klinische Immunologie, Zentrum für Innere Medizin, Innere Medizin III | Not yet recruiting |
| Ulm, Germany, 89081 | |
| Principal Investigator: Georg Härter, MD, PhD | |
| Universitätsklinikum Würzburg | Not yet recruiting |
| Würzburg, Germany, 97080 | |
| Principal Investigator: Hartwig Klinker, Prof. Dr. | |
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
| Principal Investigator: | Jan van Lunzen, MD | Infectious Diseases Unit, University Medical Center Hamburg-Eppendorf |
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. Jan van Lunzen, University Medical Center Hamburg-Eppendorf - Infectious Diseases Unit |
| ClinicalTrials.gov Identifier: | NCT01417949 History of Changes |
| Other Study ID Numbers: | EudraCT Nr. 2010-022413-26 |
| Study First Received: | August 10, 2011 |
| Last Updated: | August 15, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013