Overview

Triple vs. Double Therapy in naïves HIV-Infected Patients

Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to clarify whether if starting antiretroviral treatment based on dual therapy (DTG + 3TC) could provide less control of residual HIV replication and, therefore, a detriment on immune activation and inflammation compared to starting with triple therapy, and could worsen the patients' long-term prognosis. For this purpose, the investigator has designed a randomized clinical trial where will assess the immunological recovery (CD4+/CD8+), immune activation, proliferation, senescence and apoptosis in T lymphocytes CD4+ and CD8+ cells by flow cytometry, the immune activation of monocytes/ macrophages and plasma concentrations of various inflammatory mediators by ELISAS, and the thymic function, the cellular reservoir of HIV and the degree of HIV DNA transcription by digital dropped PCR.
Phase:
Phase 4
Details
Lead Sponsor:
Hospitales Universitarios Virgen del Rocío
Treatments:
Dolutegravir
Lamivudine