NCT04295460

Triple vs. Double Therapy in naïves HIV-Infected Patients

Effectiveness of a Dual Therapy (Dolutegravir + Lamivudine) on Reduction of the Viral Reservoir, Immune Recovery and Immune Activation Compared With a Triple Therapy (Dolutegravir + Tenofovir Alafenamide/Emtricitabine) in Treatment-naïve HIV-Infected Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hospitales Universitarios Virgen del Rocío · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Randomize	Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment

Timeline

• Start date: 2020-03-10
• Primary completion: 2022-01-01
• Completion: 2023-03-01
• First posted: 2020-03-04
• Last updated: 2020-08-18

Locations

1 site across 1 country: Spain