Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events - Full Text View

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:

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:	October 2016 (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 (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

Contacts


Contact: Jan van Lunzen, Prof. Dr.	+49 40 7410 52831	v.lunzen@uke.uni-hamburg.de

Locations


Germany
Vivantes Auguste-Viktoria-Klinikum	Recruiting
Berlin, Germany, 12157
Contact: Keikawus Arasteh, MD
Charitè Universitätsmedizin Berlin Campus Virchow Klinikum	Recruiting
Berlin, Germany, 13353
Contact: Dirk Schürmann, MD
Universitätsklinikum Bonn, Innere Medizin I, Immunologische Ambulanz/Studienzentrale	Recruiting
Bonn, Germany, 53127
Principal Investigator: Jürgen Rockstroh, MD, PhD
Medizinische Klinik Nord	Recruiting
Dortmund, Germany, 44137
Principal Investigator: Bernhard Schaaf, MD, PhD
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie	Recruiting
Düsseldorf, Germany, 40225
Principal Investigator: Stefan Reuter, MD, PhD
Universitätshauptklinik Essen	Recruiting
Essen, Germany, 45122
Principal Investigator: Guido Gerken, MD, PhD
Universitätsklinikum Frankfurt, Medizinische Klinik II / Infektiologie	Recruiting
Frankfurt am Main, Germany, 60590
Principal Investigator: Christoph Stephan, MD, PhD
Universitätsklinikum Freiburg, Centrum Chronische Immundefizienz (CCI)	Recruiting
Freiburg, Germany, 79106
Principal Investigator: Winfried Kern, MD, PhD
ifi Hamburg an der Asklepios Klinik St. Georg	Recruiting
Hamburg, Germany, 20099
Principal Investigator: Albrecht Stoehr, MD, PhD
ICH Study Center GmbH & CO. KG	Recruiting
Hamburg, Germany, 20146
Principal Investigator: Christian Hoffmann, MD, PhD
University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit,	Recruiting
Hamburg, Germany, 20249
Principal Investigator: Jan van Lunzen, MD,PhD
Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie	Recruiting
Hannover, Germany, 30625
Principal Investigator: Matthias Stoll, MD, PhD
Universitätsklinikum Kiel, II. Medizinisch Klinik, UKSH, Campus Kiel	Recruiting
Kiel, Germany, 24116
Principal Investigator: Heinz A Horst, MD, PhD
Universitätsklinik Köln, Klinik I für Innere Medizin	Recruiting
Köln, Germany, 50937
Principal Investigator: Gerd Fätkenheuer, MD, PhD
Universitätsklinikum München, Infektionsabteilung, Med. Poliklinik, Klinikum der Universität München, Campus Innenstadt	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	Recruiting
Ulm, Germany, 89081
Principal Investigator: Georg Härter, MD, PhD
Universitätsklinikum Würzburg	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


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:	May 27, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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 September 23, 2016

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