HIV infection
Conditions
Interventions
Trade Name: Biktarvy
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BICTEGRAVIR
Other descriptive name: BICTEGRAVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main efficacy objective: To 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.;Secondary Objective: To assess the safety and tolerability of the administration of triple therapy (BIC / FTC / TAF) as ART.;Primary end point(s): • Changes in time since the first visit to the HIV specialist and the first determination of viral load <50 cop / ml. • Changes in CD4 T cell count from the start of treatment until week 48 • Changes in viral suppression rates from the start of treatment until week 48 • Changes in the anxiety scale from the first visit until week 48 • Changes in the number of potential sexual contacts with risk of HIV transmission (due to the presence of detectable CV in the study subject) from the first visit to the specialist until week 48 • Changes in the quality of life from the first visit until week 48;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of adverse events (AE) and severe AA (SAE);Timepoint(s) of evaluation of this end point: 48 WEEKS | — |
Countries
Spain
Contacts
Public ContactUNIDAD DE INVESTIGACION CLINICA
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Outcome results
None listed