Randomised, controlled open label trial to compare the efficacy safety and tolerability of a treatment simplification by darunavir/ritonavir DRV/r 800/100 mg OD vs a triple combination therapy containing DRV/r in HIV-1 infected subjects with undetectable plasma HIV-1 RNA on their current treatments - TMC114HIV3006
- Conditions
- HIV-1 patients with plasma RNA HIV-1 undetectable in current treatmentMedDRA version: 9.1Level: LLTClassification code 10049829Term: Blood HIV RNA below assay limit
- Registration Number
- EUCTR2006-006437-40-IT
- Lead Sponsor
- JANSSEN-CILAG INTERNATIONAL N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
Documented HIV infection Male and female subjects aged 18 or older ICON voluntarily signed HAART therapy ongoing for 24 weeks HIV-1 RNA plasma 50 copies/ml for at least 24 weeks prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
History of virological failure defined as two consecutive plasma HIV-1 RNA 500 copies per ml while on previous or current ARV therapy History of any primary PI mutations as defined in IAS-USA guideline 2006
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate non inferiority in efficacy of DRV/r vs tritherapy containing DRV/r with restect to confirmed virologic response defined as plasma HIV-1 RNA 50 copies per ml at 48 weeks;Secondary Objective: Compare safety and tolerabiltiy of a simplified therapeutic regimen based on DRV/r therapy instead of tritherapy containing DRV/r;Primary end point(s): plasma RNA HIV-1 50 copies per ml on week 48
- Secondary Outcome Measures
Name Time Method