EUCTR2006-002582-39-IT
Active, not recruiting
Not Applicable
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
FONDAZIONE NADIR ONLUS0 sites200 target enrollmentAugust 30, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FONDAZIONE NADIR ONLUS
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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