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Completed
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
Conditions: HIV-1-infection
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 100
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Location: Spain
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
Eligibility Criteria
Inclusion Criteria:- Men and women > 18 years oldConfirmed and documented diagnosis of HIV-1 infectionWithout prior antiretroviral treatment (excluding 28-day post-exposure prophylaxis)Signed informed consentNegative 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 monthsExclusion Criteria:Inability to obtain written informed consent to participate in the studyPregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methodsAny suspicion or confirmation of resistance to TAF, FTC or BICEstimated 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 allowedContraindications to the use of TAFClinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will end the studySimultaneous 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
Source: ClinicalTrials.gov (NCT05606055). StuddyBuddy aggregates publicly available trial information.