NCT05606055

The Benefits of Immediate Treatment Initiation Without Immunovirological Data Compared to Conventional BIC / FTC / TAF Treatment in Naive Patients With Type 1 HIV (Human Immunodeficiency Virus) Infection

Phase IV, Single-center, Open Study to Evaluate the Benefits of the Start of Immediate Treatment Without Immunovirological Data ("Same Day Treatment") Compared to Conventional Treatment With BIC / FTC / TAF (Bictegravir/Emtricitabina/Tenofovir) in Naive Patients With Type 1 HIV (Human Immunodeficiency Virus) Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data ("Same Day Treatment") compared to conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV (human immunodeficiency virus) infection

Detailed description

150 patients (75 in each treatment arm) with a confirmed diagnosis of HIV-1 infection and without prior antiretroviral treatment will be included. Expected study period 48 weeks of treatment Main objective of effectiveness Determine the time from the first determination of CD4 and HIV-1 viral load to achieve HIV viral load \<50 cop / ml. Secondary objectives of efficacy * Evaluate changes in CD4 T cell count. * Determine the time from HIV diagnosis to achieve undetectable HIV viral load. * Determine the degree of anxiety of patients. * Determine the number of sexual contacts with potential for transmission of HIV infection. * Determine the quality of patients before and after SDT. Both arms of the study have the same treatment with triple therapy (BIC / FTC / TAF). The treatment guidelines will be as follows: * Patients in the immediate treatment arm (SDT) will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF) orally, once a day, from the moment they are seen in the specialist's office (without immunovirological data information). * Patients in the conventional treatment arm will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF) orally, once a day, from the moment the immunovirological results are obtained (either because it is available them at the first visit with the specialist, or because the patient wishes to wait for such information prior to the start of the treatment). It is a single-center, open and non-randomized study. 150 adult patients with confirmed diagnosis of HIV-1 and without prior antiretroviral treatment may participate in the study. Patients will be divided into two groups, one in immediate treatment (arm 1 or SDT) and another in conventional treatment (arm 2), both strategies being considered part of the usual clinical practice that leads to a low intervention study. * 75 patients of immediate treatment, will be those patients without immuno-virological data that accept to start the treatment the same day of the first consultation with the hospital specialist (arm 1 or SDT). * 75 patients of conventional treatment, will be those who in their first consultation with the hospital specialist already have previous immuno-virological data or reject the start of immediate treatment (arm 2). Patients will voluntarily grant informed consent before performing any study procedure and will be assigned a patient code for the entire study. The study will include a total of 5 visits and periodic clinical exams will be performed on visits of weeks 0, 4, 12, 24 and 48.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	BIC/FTC/TAF: Bictegravir/emtricitabina/tenofovir alafenamida fumarato	This is a study to assess the impact of immediate ART (FAST ART or SDT) against conventional treatment (CT) on the time to reach an undetectable HIV-1 viral load.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-02-01
• Completion: 2022-03-03
• First posted: 2022-11-04
• Last updated: 2022-11-04

Locations

1 site across 1 country: Spain