Status:
COMPLETED
Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV+ Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiv...
Detailed Description
Patients will receive one of the current standard of care regimens for the treatment of HIV infection, i.e. nevirapine (Viramune®) must be administered in conjunction with 2NRTIs, as prescribed by the...
Eligibility Criteria
Inclusion
- Main Inclusion criteria:
- Subject suffering with clinically evident fat redistribution including the lipodystrophic syndrome and/or with abnormal values of triglycerides, cholesterol and/or insulin resistance
- Subject on treatment with HAART including PIs for at least 9 months, without therapeutic changes for at least 6 months
- Baseline CD4+ \>200 cells/mm3
- HIV-1 RNA levels \<200 copies/mL at baseline and during the previous 6 months
- Main Exclusion criteria:
- Subject with other serious or chronic disease unrelated to HIV
- Subject with active invasive infections
- Subject with Karnofsky score less than 50
- Prior NNRTs experience
- Documented or suspected acute hepatitis within 30 days prior to baseline visit, irrespective of AST and ALT values that are \>5 ULN
- Subject receiving hypolipidemic and/or antidiabetic drugs at study entry
- Subjects with central nervous system disease or pre-existing mental disturbance
- Subjects on methadone chronic treatment at study entry
Exclusion
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00274001
Start Date
September 1 2001
End Date
March 1 2004
Last Update
November 1 2013
Active Locations (24)
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1
Ospedale Regionale
Ancona, Italy, 60020
2
Ospedale Santa Maria Annunziata
Antella (fi), Italy, 50011
3
Clinica di Malattie Infettive
Bari, Italy, 70124
4
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128