HIV AIDS
Conditions
Interventions
Trade Name: BIKTARVY
Product Name: BIKTARVY
Product Code: EMEA/H/C/004449
Pharmaceutical Form: Coated tablet
Sponsors
Gileas Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants wishing to take part in the study must meet all of the criteria listed below: 1. Vulnerable person =18 years old. 2. Understand and sign the informed consent form. 3. Confirmed HIV infection. 4. HIV viral load >1000 copies/mL 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Exclusion criteria. Participants with any of the following criteria will not be eligible to participate: 1. inability to provide contact details. 2. History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine. 3. Have been on antiretroviral treatment for less than 6 months and have no evidence of poor adherence to ART or hospital appointments. 4. Pregnancy or breastfeeding at the time of screening or gestational desires during the study period. 5. Suspected or diagnosed active opportunistic disease. 6. History of severe liver disease (Child-Pugh C) or history of decompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice). 7. History of renal disease CKP-EPI<30ml/min. 8. Presenting any condition which, in the opinion of the researcher, makes the patient not a candidate for inclusion (active disease, social situation, intoxication, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective. To implement a model of access and retention in HIV care for vulnerable people using a mobile screening unit and a same-day diagnosis and treatment initiation strategy.;Secondary Objective: Secondary objectives. 1) To evaluate the effectiveness of the strategy. 2) To assess the safety of the strategy. 3) To assess the implementation and feasibility of the intervention;Primary end point(s): ASSESSMENT OF TRIAL ENDPOINTS. Assessing the effectiveness of the strategy Proportion of subjects who agree to participate in the study. Proportion of subjects initiating ART after enrolment. Median time from study enrolment to ART initiation. Proportion of subjects with plasma HIV-1 RNA <50 copies/mL at 24 weeks after enrolment. Absolute values and changes from baseline in CD4+ cell count and CD4:CD8 ratio at 24 weeks. Proportion of subjects making visits at weeks 24 and 48. To assess the safety of the strategy Incidence and severity of adverse events (clinical and laboratory) up to week 24. Incidence of adverse events leading to treatment discontinuation up to week 24. Incidence of genotypic resistance mutations in participants with virologic failure at week 48.;Timepoint(s) of evaluation of this end point: The duration of the study is defined for each participant as the date the signed written informed consent is provided until the last follow-up visit, which can be up to month 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate strategy implementation - Assessment of the acceptability, convenience, appropriateness, usefulness, appropriateness, quality and perceived benefit and satisfaction of the intervention (see Appendix 6 ) at the baseline visit and at the week 24 visit. These parameters will be collected on a scale of 0 to 5. - To evaluate the implementation of this project, in addition to the aspects of the previous point, the endpoints referred to above will be used (Evaluate the effectiveness of the strategy and Evaluate the safety of the strategy).;Timepoint(s) of evaluation of this end point: The duration of the study is defined for each participant as the date the signed written informed consent is provided until the last follow-up visit, which can be up to month 18 | — |
Countries
Spain
Contacts
Public ContactMarta de Miguel Montero
Fundacion SEIMC-Gesida
Outcome results
None listed