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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01417949
First received: August 10, 2011
Last updated: May 27, 2013
Last verified: May 2013

August 10, 2011
May 27, 2013
August 2011
October 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01417949 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events
Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL-Study)

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-Infection
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: Immediate arm
    Immediate arm: ART should be initiated as soon as possible but no later than 3 days after initiation of OI treatment.
    Intervention: Other: Time of starting antiretroviral therapy
  • 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.
    Intervention: Other: Time of starting antiretroviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
Not Provided
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jan van Lunzen, Prof. Dr. +49 40 7410 52831 v.lunzen@uke.uni-hamburg.de
Germany
 
NCT01417949
EudraCT Nr. 2010-022413-26
Yes
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Jan van Lunzen, MD Infectious Diseases Unit, University Medical Center Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP