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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-006437-40-IT
• Date of registration: 24/04/2007
• Prospective Registration: Yes
• Primary sponsor: JANSSEN-CILAG INTERNATIONAL N.V.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 23/05/2007
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006437-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Denmark, Germany, Hungary, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV-1 patients with plasma RNA HIV-1 undetectable in current treatment
MedDRA version: 9.1 Level: LLT Classification code 10049829 Term: Blood HIV RNA below assay limit

Intervention(s)

Product Name: darunavir
Product Code: TMC114
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: TMC114
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: NORVIR
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: Compare safety and tolerabiltiy of a simplified therapeutic regimen based on DRV/r therapy instead of tritherapy containing DRV/r

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

Primary end point(s): plasma RNA HIV-1 50 copies per ml on week 48

Secondary ID(s)

2006-006437-40-GB

TMC114HIV3006