NCT04295460

Triple vs. Double Therapy in naïves HIV-Infected Patients

Name: Clinical Trial NCT04295460
Creator: Hospitales Universitarios Virgen del Rocío
Keywords: HIV Infection, Randomize, Phase 4, drug, clinical trial, Spain

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

Hospitales Universitarios Virgen del Rocío·Phase 4·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: HIV Infection
Drug/Device/Intervention: Randomize
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Hospitales Universitarios Virgen del Rocío
Location: Seville, Spain

Timeline & enrollment

Phase: Phase 4
Start date: Mar 10, 2020
End date: Mar 01, 2023
Enrollment: 70 participants

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

HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04295460
Type: Non-Device Trial

About this record

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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