A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada for Pre-Exposure Prophylaxis (PrEP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37077
• EU PAS number:
  EUPAS24374
• Study ID:
  37077
• Official title and acronym:
  A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada for Pre-Exposure Prophylaxis (PrEP)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Benin

  Brazil

  Canada

  China

  France

  Kenya

  Malawi

  Netherlands

  Peru

  South Africa

  Tanzania, United Republic of

  Thailand

  Uganda

  United Kingdom

  United States

  Zimbabwe
• Study description:
  GS-US-276-0103: This study evaluated HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assessed the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collected information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 15 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/11/2012

Actual: 30/11/2012

Study start date

Planned: 02/09/2013

Actual: 02/09/2013

Date of final study report

Planned: 30/06/2020

Actual: 20/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences, Inc.

Study protocol

Initial protocol

protocol GS-US-276-0103_f-redact

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

NCT01902472https://clinicaltrials.gov/ct2/show/NCT01902472