Triple vs. Double Therapy in naïves HIV-Infected Patients - Trial NCT04295460
Access comprehensive clinical trial information for NCT04295460 through Pure Global AI's free database. This Phase 4 trial is sponsored by Hospitales Universitarios Virgen del Rocío and is currently Recruiting. The study focuses on HIV Infection. Target enrollment is 70 participants.
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Study Focus
Sponsor & Location
Hospitales Universitarios Virgen del Rocío
Timeline & Enrollment
Phase 4
Mar 10, 2020
Mar 01, 2023
Primary Outcome
proviral HIV-DNA
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04295460
Non-Device Trial