Status:
COMPLETED
Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
HIV-Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 pa...
Detailed Description
Objectives: To compare the early versus deferred initiation of antiretroviral combination therapy consisting of tenofovir, emtricitabine and atazanavir/ritonavir in treatment naive patients who prese...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01417949
Start Date
August 1 2011
End Date
May 1 2015
Last Update
November 28 2016
Active Locations (17)
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1
ICH Study Center GmbH & CO. KG
Hamburg, Hamburg, Germany, 20146
2
Vivantes Auguste-Viktoria-Klinikum
Berlin, State of Berlin, Germany, 12157
3
Charitè Universitätsmedizin Berlin Campus Virchow Klinikum
Berlin, State of Berlin, Germany, 13353
4
Universitätsklinikum Bonn, Innere Medizin I, Immunologische Ambulanz/Studienzentrale
Bonn, Germany, 53127