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

NCT05606055 | Completed Phase 4 DMC

• 1 other identifier: 123456
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Efficacy of immediate treatment.

  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.

  48 weeks

Secondary Outcomes (1)

• Secondary Efficacy Endpoints

  48 weeks

Study Arms (2)

SDT

EXPERIMENTAL

-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

Conventional

ACTIVE COMPARATOR

\- 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

Interventions

BIC/FTC/TAF: Bictegravir/emtricitabina/tenofovir alafenamida fumarato DRUG

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.

Conventional; SDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Hospital FUNDACIÓN JIMÉNEZ DÍAZ

Madrid, Spain

Location

Related Publications (2)

• Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006 Jun 26;20(10):1447-50. doi: 10.1097/01.aids.0000233579.79714.8d.

  PMID: 16791020 RESULT

• Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

  PMID: 28867497 RESULT

Related Links

• UNAIDS is leading the global effort to end AIDS as a public health threat by 2030 as part of the Sustainable Development Goals.
• GUIDELINES FOR MANAGING ADVANCED HIV DISEASE AND RAPID INITIATION OF ANTIRETROVIRAL THERAPY

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subinvestigator Infectious disease. Irene Carrillo

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: November 4, 2022
• Study Start: December 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 3, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)