Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for HIV Pre-Exposure Prophylaxis (PrEP): A Pooled Observational Study

Study identification

• EU PAS number:
  EUPAS24332
• Study ID:
  41844
• Official title and acronym:
  Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for HIV Pre-Exposure Prophylaxis (PrEP): A Pooled Observational Study
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Benin

  Brazil

  Canada

  Denmark

  Ecuador

  France

  Germany

  Ireland

  Italy

  Kenya

  Netherlands

  Peru

  South Africa

  Spain

  Thailand

  Uganda

  United Kingdom

  United States

  Zimbabwe
• Study description:
  GS-US-276-0104:This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Truvada for PrEP. All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, HIV-1 status, renal and bone adverse events, and seroconversion. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol. Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/04/2013

Actual: 02/11/2012

Study start date

Planned: 01/01/2014

Actual: 07/10/2013

Date of final study report

Planned: 30/12/2021

Actual: 27/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT01906255,,https://clinicaltrials.gov/ct2/show/NCT01906255?term=276-0104&rank=1