EUCTR2006-006437-40-IT
Active, not recruiting
Not Applicable
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
ConditionsHIV-1 patients with plasma RNA HIV-1 undetectable in current treatmentMedDRA version: 9.1Level: LLTClassification code 10049829Term: Blood HIV RNA below assay limit
DrugsNORVIR
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1 patients with plasma RNA HIV-1 undetectable in current treatment
- Sponsor
- JANSSEN-CILAG INTERNATIONAL N.V.
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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