PROTEA: A clinical trial comparing the efficacy of darunavir/ritonavir 800/100 mg monotherapy versus a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors in patients with undetectable plasma HIV-1 RNA on current treatment
- Conditions
- HIV-1 infectionMedDRA version: 14.0Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-001635-23-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
- 260
HIV-1 infection; receiving HAART for at least 48 weeks; Have plasma HIV-1 RNA <50 copies/mL for at least 48 weeks prior to 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 255
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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 coinfected with hepatitis B
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method