Status:
COMPLETED
Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only
Lead Sponsor:
Hospital de Calella
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 \< 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.
Detailed Description
RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingl...
Eligibility Criteria
Inclusion
- Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
- Age \>= 18 years.
- Confirmed diagnosis of HIV-1 infection.
- Viral load \< 50 copies/ml over the previous six months, including at least two consecutive determinations.
- Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
- Acceptance and signature of the informed consent form.
Exclusion
- Pregnant women or those who intend to become pregnant in the study period.
- Having had an active infection in the previous month.
- Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
- Simultaneous treatment with methadone.
- Patients with serious hepatic dysfunction
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00415090
Start Date
August 1 2004
End Date
July 1 2006
Last Update
October 31 2008
Active Locations (17)
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1
Hospital.Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Centre Penitenciari Brians
Barcelona, Barcelona, Spain, 08009
3
Hopsital de Sant Pau
Barcelona, Barcelona, Spain, 08025
4
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain, 08035