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

• Status: Completed
• Trial end date: 2022-03-03
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Treatments: Emtricitabine; Tenofovir

Criteria

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