HIV Infections Clinical Trial
Official title:
Study of the Influence of Atorvastatin in Plasma Viral Replication Given Prior to Antiretroviral Treatment Interruption in Patients With HIV-1 Infection and Viral Suppression.
To determine the influence of atorvastatin on plasma viral replication when the latter is given before and during highly active anti-retroviral therapy (HAART) in patients with HIV infection and viral suppression.
Recently, the inhibitory effect of the statins on the replication of the human
immunodeficiency virus Type 1 (HIV-1) through two independent mechanisms of action has been
described: the blockade of Rho guanosine triphosphatase that intervenes in the entry and
exit of the virus and the blockade of the interaction between LFA-1 (leukocyte function
antigen 1) and its ICAM 1 ligand (intercellular adhesion molecule 1) that intervenes in the
process through which the virus binds to the target cell.
These initial data have led to the study of the effect of atorvastatin on the plasma
replication of HIV in HIV+ patients that interrupt antiretroviral therapy (Ator Study 3)
developed in our unit. The data of this study indicate that baseline plasma cholesterol
determines viral load rebound on interrupting antiretroviral treatment. However, the
introduction of atorvastatin on the day of interruption provided no virological or
immunological benefit in comparison with an interruption of antiretrovirals without statins.
This may be due to the fact that the potent inhibitory effect of atorvastatin is unable to
compensate their activating effect on the production of HIV also described in our study.
Overall, our results pose a possible usefulness of atorvastatin in the control of viral
replication if given before the interruption of antiretroviral therapy due to:
- Their capacity to reduce serum cholesterol at the time of interruption and consequently
the cholesterol of the cell membrane.
- Their potent capacity to purge the HIV reservoir
Therefore, in this study we aim to investigate the impact of atorvastatin on viral
replication when it is given 8 weeks before the interruption of the antiretroviral treatment
and determine whether this impact is due to the reduction in serum and/or membrane
cholesterol, or whether, on the other hand, there is a contribution by atorvastatin's
capacity to induce the expression of viral products.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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