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Clinical Trials/EUCTR2006-002582-39-IT
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.

Registry
who.int
Start Date
August 30, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FONDAZIONE NADIR ONLUS

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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