A Phase 4 interventional study of BIC/FTC/TAF in HIV Infections, sponsored by Carmen Hidalgo Tenorio. Completed at 15 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Carmen Hidalgo Tenorio · Phase 4, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 208 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →This is the only study on the registry with Carmen Hidalgo Tenorio as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HIV-1 infected adults, ART-naive subjects, who start BIC/FTC/TAF using test and treat strategy recruited at infectious diseases units from various Spanish public healthcare centers.
Drug: BIC/FTC/TAF
TEST and TREAT strategy: Study group will start the intervention at the first visit with their healthcare provider.
HIV-1 RNA in plasma (week 24)
copies of HIV RNA -1 in plasma at week 24
Time frame: 24 week
HIV-1 RNA in plasma week 48
copies of HIV RNA -1 in plasma at week 48
Time frame: 48 week
Medicaction adherence
proportion of pills taken, self-reported
Time frame: 48 week
Retention in care
Subjects completing all study visits
Time frame: 48 week
Quality of Life patient reported outcomes EQ-5D
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)
Time frame: 48 week
Quality of Life patient reported outcomes dichotomized HIV-Symptoms Index
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
Time frame: 48 week
Feasibility of test and treat strategy
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
Time frame: 48 week
demographics and baseline characteristics
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
Time frame: 48 week
viral resistance
Incidence of treatment-emergent genotypic or/and phenotypic resistence to any ART
Time frame: 48 week
antiviral activity
Time to viral suppression and absolute changes from baseline in lymphocyte count at week 48
Time frame: 48 week
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence and severity of adverse events and laboratory abnormalities
Time frame: 48 week
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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