Status:
COMPLETED
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
HIV Infections
AIDS Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucle...
Detailed Description
This study is randomised (patients are assigned different treatments based on chance), controlled, open-label trial to compare the efficacy, safety and tolerability of darunavir/ritonavir (DRV/r) 800/...
Eligibility Criteria
Inclusion
- Patients with documented HIV-1 infection
- Patients currently receiving HAART for at least 24 weeks
- Plasma viral load \< 50 copies/mL for at least 24 weeks prior to screening (two results must be documented)
- Patients taking the same antiretroviral combination for at least 8 weeks before screening
- Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity
- CD4 \> 100/mm3 at the start of HAART and \> 200/mm3 at screening.
Exclusion
- No history of virological failure defined as two consecutive plasma HIV-1 RNA \> 500 copies/mL while on previous or current antiretroviral therapy
- No history of any primary PI mutations as defined by the IAS-USA guidelines 2006
- No patients co-infected with hepatitis B
- No pregnant or breastfeeding women
- No active clinically significant disease or life threatening disease or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00458302
Start Date
June 1 2007
End Date
January 1 2011
Last Update
December 19 2012
Active Locations (27)
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1
Vienna, Austria
2
Antwerp, Belgium
3
Brussels, Belgium
4
Aarhus, Denmark