Study identification

PURI

https://redirect.ema.europa.eu/resource/38881

EU PAS number

EUPAS11010

Study ID

38881

Official title and acronym

Non-Interventional Real-Life Study of Effectiveness, Safety, Adherence, and Health-Related Quality of Life in Adult Patients receiving Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (E/C/F/TAF) or Emtricitabine/Tenofovir alafenamide (F/TAF) or Rilpivirine/Emtricitabine/Tenofovir alafenamide (R/F/TAF) for HIV-1 Infection in Germany (TAFNES)

DARWIN EU® study

No

Study countries

Germany

Study description

GS-DE-292-1912: The study enrolled 767 adult (age ≥ 18) treatment-naive and treatment-experienced HIV-1 infected subjects initiating treatment with E/C/F/TAF (318), F/TAF (257) or R/F/TAF (192) in routine care. The study enrolled treatment-naïve and treatment-experienced subjects in each arm. Enrolled subjects were documented for 24 months. The study descriptively analysed effectiveness, safety, resource utilization, and patient reported outcomes for quality of life for the use of E/C/F/TAF, F/TAF or R/F/TAF in routine care.

Study status

Finalised
Research institution and networks

Institutions

Gilead Sciences
First published:
12/02/2024
Institution
Pharmaceutical company
Multiple centres: 38 centres are involved in the study

Contact details

Gilead Study Director

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences
Study protocol
Initial protocol

amd-1-GS-DE-292-1912-FINAL-COMPLETE

English (1.48 MB - PDF)View document
Updated protocol

GS-DE-292-1912-appendix-16.1.1-protocol-amendment 2_f-redact

English (1.42 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable