Status:
COMPLETED
A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Human Immunodeficiency Virus (HIV) Infections
Acquired Immunodeficiency Syndrome (AIDS) Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg ...
Detailed Description
This is phase IIIb, randomised (study medication is assigned by chance), open-label (both the patient and the study physician will know to which treatment group the patient is assigned) trial to compa...
Eligibility Criteria
Inclusion
- HIV-1 infection
- receiving HAART for at least 48 weeks
- Have at least 2 documented plasma HIV-1 RNA \<50 copies/mL, and no HIV-1 RNA \>=50 copies/mL in the 48 weeks prior to the screening
- Be taking the same antiretroviral (ARV) combination for at least 8 weeks before screening
- Have the preference, together with the physician, to change the current HAART regimen for reasons of simplification and/or toxicity
Exclusion
- Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA \>500 copies/mL while on previous or current antiretroviral therapy
- Has a history of any primary PI mutations
- Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency)
- Is diagnosed with acute viral hepatitis at screening or before Baseline 1
- Is co-infected with hepatitis B
Key Trial Info
Start Date :
March 15 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2015
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT01448707
Start Date
March 15 2012
End Date
March 18 2015
Last Update
November 27 2017
Active Locations (34)
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1
Graz, Austria
2
Vienna, Austria
3
Antwerp, Belgium
4
Brussels, Belgium