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 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)

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 ]
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 ]
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.


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)
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

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
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

ClinicalTrials.gov processed this record on August 22, 2017

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