Tripe Versus Dual Antiretroviral Therapy in HIV-infected Patients With Virological Suppression (Tridual)
Status:
Completed
Trial end date:
2021-02-03
Target enrollment:
Participant gender:
Summary
The persistence of an aberrant state of immune activation and inflammation (pIA) may
contribute to the emergence of serious non-AIDS events which carry a higher morbimortality in
HIV-infected patients. Although combined antiretroviral treatment (cART) reduces both
cellular and soluble activation markers, it fails to completely control pIA despite
consistent plasma viral load suppression. One of the mechanisms involved in pIA is may be an
incomplete suppression of viral replication not reflected by plasma viral load, which only
reflects a balance between viral replication and clearance of HIV-RNA. In addition, low-level
viremia detected in most HIV-1-infected patients despite years on cART. Unintegrated 2-LTR
HIV-DNA, and cellular associated HIV-RNAs, as products of active integrated DNA
transcription, support this issue.
Furthermore, the key rationales behind simplifying cART are a reduction of toxicities, lower
risk of resistance mutations in case of virological failure and saving costs. One of these
simplification strategies is a dual therapy which, based on the data up to date and in our
clinical experience, has similar virological efficacy than cART. However, it is unknown if
this strategy could increase the persistent HIV-1 replication and, therefore, pIA. The
CD4+/CD8+ T cell ratio as a marker of immune recovery, the changes in T cell immune
activation, senescence, exhaustion and apoptosis, and the cellular associated HIV-DNA and
-RNA would answer the question if simplification to dual therapy would provide less control
of residual HIV replication and, therefore, a detriment on pIA compared to triple therapy
and, therefore, would worsen the patients' long-term prognosis.
Phase:
Phase 4
Details
Lead Sponsor:
Hospitales Universitarios Virgen del Rocío
Collaborators:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Instituto de Salud Carlos III