Study identification

EU PAS number

EUPAS108061

Study ID

108126

Official title and acronym

Study of Bictegravir/Emtricitavine/Tenofovir alafenamide in HIV-1 infected naïve patients using test and treat stategy rapid-initiation model of care: BIC-NOW clinical trial (BIC-NOW)

DARWIN EU® study

No

Study countries

Spain

Study description

The HIV epidemic is not over, according to data of WHO and UNAIDS in 2017, a total of 36.9 million people infected with HIV in the world, 1,8 million people were newly infected with HIV, and 10% of those among children <15 years old. In Spain there are more than 10 new infections diagnosed every day, a 0,2% of world total, with 3381 new infections and a total of 140.000-170.000 are living in Spain with HIV at 2017, 18% of those do not knowing it. In the province of Andalusia, results are better but still high with 574 new infections in 2017 (6.85/100.000 pp) Bictegravir (BIC) is an INSTI commercialized is Spain in a single tablet regimen (STR) associated with TAF/FTC, have a great genetic barrier (so do not need a previous genotypic resistance test to be prescribed) and does not experience differences in effectivity from gender, race, age, CD4 count or plasmatic viral load, no need of HLA study and only creatinine is needed to be prescribed (use is not recommended in patients with CrCl <30 mL/minute) Until now, the only ART capable of that was TAF/FTC/DRV/c, demonstrated in the DIAMOND clinical trial For all the reasons above, the primary objective 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. Secondary clinical objectives are: To evaluate the effect of patient demographics and baseline characteristics on response to BIC/FTC/TAF over time, to asses viral resistance tests in subject meeting confirmed virologic failure, to evaluate antiviral activity, to evaluate the safety and tolerability of BIC/FTC/TAF over time, to analyze subject adherence to the healthcare system.

Study status

Ongoing

Contact details

HIDALGO-TENORIO CARMEN

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GILEAD
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable