Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
