HIV Infections Clinical Trial
Official title:
Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors
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.
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 increasingly better described and acknowledged, whereby the number of salvage regimens
that may be built following the appearance of this resistance to these drugs is by no means
unlimited.
This proactive treatment change in patients on RTNI-based regimens while the viral load is
still suppressed would avoid the selective replication period under antiviral pressure
following the failure of the regimen in which resistance-associated mutations accumulate.
This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit
not in this scenario.
If we wait until the viral load is detectable there is sufficient evidence that resistance
to RTNI will appear and that this resistance will compromise future salvage options.
To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide
analog), the NNRTI are an optimal alternative.There is vast experience with NVP in
simplification/maintenance trials. In direct comparative simplification studies in patients
with virological response, the response rates with NVP or EFV have shown no differences.
With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of
PI (protease inhibitors), NVP is one of the best simplification treatment options in
HIV-1-infected patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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