HIV Infections
Conditions
Keywords
HIV, TEST and TREAT, IMPLEMENTATION
Brief summary
The goal of this study is to analyze in treatment-naïve HIV patients the antiviral activity, using a test and treat strategy, in real life of BIC/FTC/TAF. Secondary, this study aims to evaluate outcomes for implementation of the evidence based test and treat strategy.
Interventions
DRUGBIC/FTC/TAF
TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.
Sponsors
Gilead Sciences
Carmen Hidalgo Tenorio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV-1 infected adults (\>17 y.o.) 2. Antiretroviral-naïve. 3. Be able to comply with protocol requirements and instructions. 4. Subject or the subject's representative capable of giving signed informed consent
Exclusion criteria
1. Women who are breastfeeding or plan to become pregnant during the study. 2. Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending. 3. Patients with anticipated need to change the ART before study ending.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 RNA in plasma (week 24) | 24 week | copies of HIV RNA -1 in plasma at week 24 |
| HIV-1 RNA in plasma week 48 | 48 week | copies of HIV RNA -1 in plasma at week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life patient reported outcomes EQ-5D | 48 week | effect of test and treat strategy on health related quality of life and HIV-related symptoms to treatment-naïve HIV patients through PROs EQ-5D (Five dimensions descriptive system of quality of live from EuroQoL) |
| Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index | 48 week | effect of test and treat strategy on health related quality of life and HIV-related symptoms to treatment-naïve HIV patients through PROs dichotomized HIV-SI |
| Feasibility of test and treat strategy | 48 week | Time to full enrolment of 139 eligible treatment-naïve HIV patients at 22 public healthcare centers in Spain and by physicians using screening data reports |
| Medicaction adherence | 48 week | proportion of pills taken, self-reported |
| viral resistance | 48 week | Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART |
| antiviral activity | 48 week | Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 48 week | Incidence and severity of adverse events and laboratory abnormalities |
| demographics and baseline characteristics | 48 week | Proportion of subjects by patient subgroup (e.g. by gender, age…) with plasma HIV-1 RNA \<50 copies/mL at week 48 using FDA Snapshot algorithm |
| Retention in care | 48 week | Subjects completing all study visits |
Countries
Spain
Outcome results
None listed