HIV Infections Clinical Trial
Official title:
Randomised, Prospective Multicentre Clinical Study on the Effect of the Combination of Lopinavir/Rtv + Nevirapine as Maintenance Bitherapy (Without Nucleoside Analogues) in Comparison With a Triple Therapy Including Lopinavir/Rtv + Nucleoside Analogues in HIV-Infected Patients
The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.
At the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of
toxicity associated with nucleoside analogues, including lipoatrophy, which at facial level
is a stigmatising factor for patients with HIV infection.
The primary outcome measure of the design of an "NTRI-sparing" bitherapy is to retard the
onset of mitochondrial toxicity or reverse it, mainly with regard to the loss of
subcutaneous fat or lipoatrophy.
Lopinavir/ritonavir and nevirapine are two antiretrovirals with different mutation patterns
and with high antiviral potency. Their combination therefore guarantees antiviral success.
The NEKA study endorses efficacy immunologically and virologically (Negredo E. et al,
NRTI-sparing regimen. XIV International AIDS Conference. Barcelona 2002. LB PeB9021).
Similarly, the protective effect of nevirapine on lipid metabolism would counteract the
negative impact attributed to lopinavir/ritonavir, reducing cardiovascular risk in these
patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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