Comparing Weight Gain on F/TAF and Placebo Using DISCOVER and iPrEx Study Data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000509
• EU PAS number:
  EUPAS1000000509
• Study ID:
  1000000509
• Official title and acronym:
  Comparing Weight Gain on F/TAF and Placebo Using DISCOVER and iPrEx Study Data
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Brazil

  Canada

  Denmark

  Ecuador

  France

  Germany

  Ireland

  Italy

  Netherlands

  Peru

  South Africa

  Spain

  Thailand

  United Kingdom

  United States
• Study description:
  GS-US-311-7562: This is a non-interventional study utilizing data from 2 Phase 3 Clinical studies, iPrEx (Study CO-US-104-0288; NCT00458393; emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®, FTC/TDF) versus placebo) and DISCOVER (Study GS-US-412-2055; NCT02842086; emtricitabine/tenofovir alafenamide (coformulated; Descovy®, F/TAF) versus FTC/TDF) to compare F/TAF with placebo weight trajectories, using the common FTC/TDF groups as a negative control to assess the validity of the primary analysis results. ; ; The primary objective of this study is to compare weight change/trajectory distributions between F/TAF and placebo cohorts.
• Study status:
  Planned

Research institutions and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Planned: 01/12/2025

Study start date

Planned: 30/04/2025

Date of final study report

Planned: 31/03/2026

Study protocol

Initial protocol

GS-US-311-7562-appendix-16.1.1-Observational Study Protocol_f-redact.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable