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

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other)

Overall Status

Completed

CT.gov ID

NCT05606055

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection	Drug: BIC/FTC/TAF: Bictegravir/emtricitabina/tenofovir alafenamida fumarato	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Mar 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SDT -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).	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.
Active Comparator: Conventional - 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 or conventional).	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.

Arm

Intervention/Treatment

Experimental: SDT

-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).

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.

Active Comparator: Conventional

- 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 or conventional).

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.

Outcome Measures

Primary Outcome Measures

Efficacy of immediate treatment. [48 weeks]
The time in weeks from the first determination of CD4 and HIV-1 viral load until achieving HIV viral load <50 cop/ml, in number.

Secondary Outcome Measures

Secondary Efficacy Endpoints [48 weeks]
CD4 cell count in number Time from HIV diagnosis to achieving undetectable HIV viral load, in weeks. Degree of anxiety of patients (mild, moderate and severe degree according to the HADS scale). Number of sexual contacts with potential for transmission of HIV infection, in number. Quality of patients before and after SDT, según escala EQ-5D 5 (numerical value from 1 to 5).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women > 18 years old
Confirmed and documented diagnosis of HIV-1 infection
Without prior antiretroviral treatment (excluding 28-day post-exposure prophylaxis)
Signed informed consent
Negative pregnancy test (women of childbearing age only). Women of childbearing age are considered to be those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months

Exclusion Criteria:

Inability to obtain written informed consent to participate in the study
Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods
Any suspicion or confirmation of resistance to TAF, FTC or BIC
Estimated glomerular filtration rate (TFGe) <30 mg / ml / m2 measured by any of the available formulas. The determination of the TFGe of a routine prior analysis of ≤ 12 weeks prior to the signing of the consent is allowed
Contraindications to the use of TAF
Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will end the study
Simultaneous participation in another clinical trial or research study that requires the need for treatment with other drugs outside the study or interferes with visits to it.
Any situation that, in the opinion of the investigator, may interfere with the patient's ability to comply with the treatment schedule and protocol evaluations