A multicenter, randomized, prospective, controlled study to evaluate the efficacy and the tolerability of a switch to a two different-dosed, nevirapine-based HAARTs in HIV-1 infected patients with undetectable plasma viremia. - SNODO
- Conditions
- pazienti HIV-1 positiviMedDRA version: 6.1Level: PTClassification code 10000565
- Registration Number
- EUCTR2006-002582-39-IT
- Lead Sponsor
- FONDAZIONE NADIR ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
HIV-1 documented infection Age 18 and 65 years Current therapy with a HAART including 1 PI ritonavir and 2 NRTIs Any CD4 cell count see exclusion criteria for female patients Plasma HIV-RNA 50 copies/mL for at least 6 months before randomization Stable clinical conditions
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) no
F.1.3.1 Number of subjects for this age range
Active opportunistic infections, neoplasms, acute viral hepatitis, drug or alcohol abuse. Chronic hepatitis caused by HBV od HCV is not a cause for exclusion CD4 cell count 250 cells/microliter in female subjects Unability to give and/or to maintain an informed consent Previous NNRTI treatment that was discontinued due to virologic failure Previous nevirapine treatment that was discontinued due to intolerance and/or toxicity
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